COVID-19 Updates

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

HIV increases the risk for severe COVID-19 by 6% and the risk of dying of COVID-19 in the hospital by 30%, according to a report from the World Health Organization on COVID-19 outcomes among people living with HIV. The study primarily included people from South Africa but also some data from other parts of the world, including the United States.

However, the report, presented at the 11th IAS Conference on HIV Science (IAS 2021), couldn’t answer some crucial questions clinicians have been wondering about since the COVID-19 pandemic began. For example, was the increase in COVID risk a result of the presence of HIV or because of the immune compromise caused by untreated HIV?

The report didn’t include data on viral load or CD counts, both used to evaluate the health of a person’s immune system. On effective treatment, people living with HIV have a lifespan close to their HIV-negative peers. And effective treatment causes undetectable viral loads which, when maintained for 6 months or more, eliminates transmission of HIV to sexual partners.

What’s clear is that in people with HIV, as in people without HIV, older people, men, and people with diabetes, hypertension, or obesity had the worst outcomes and were most likely to die from COVID-19.

For David Malebranche, MD, MPH, an internal medicine doctor who provides primary care for people in Atlanta, and who was not involved in the study, the WHO study didn’t add anything new. He already recommends the COVID-19 vaccine for all of his patients, HIV-positive or not.

“We don’t have any information from this about the T-cell counts [or] the rates of viral suppression, which I think is tremendously important,” he told this news organization. “To bypass that and not include that in any of the discussion puts the results in a questionable place for me.”

The results come from the WHO Clinical Platform, which culls data from WHO member country surveillance as well as manual case reports from all over the world. By April 29, data on 268,412 people hospitalized with COVID-19 from 37 countries were reported to the platform. Of those, 22,640 people are from the U.S.

A total of 15,522 participants worldwide were living with HIV, 664 in the United States. All U.S. cases were reported from the New York City Health and Hospitals system, Henry Ford Hospital in Detroit, and BronxCare Health System in New York City. Almost all of the remaining participants lived in South Africa – 14,682 of the 15,522, or 94.5%.

Of the 15,522 people living with HIV in the overall group, 37.1% of participants were male, and their median age was 45 years. More than 1 in 3 (36.2%) were admitted with severe or critical COVID-19, and nearly one quarter – 23.1% – with a known outcome died. More than half had one or more chronic conditions, including those that themselves are associated with worse COVID-19 outcomes, such as hypertension (in 33.2% of the participants), diabetes (22.7%), and BMIs above 30 (16.9%). In addition, 8.9% were smokers, 6.6% had chronic pulmonary disease, and 4.3% had chronic heart disease.

After adjusting for those chronic conditions, age, and sex, people living with HIV had a 6% higher rate of severe or critical COVID-19 illness. When investigators adjusted the analysis additionally to differentiate outcomes based on not just the presence of comorbid conditions but the number of them a person had, that increased risk rose to 13%. HIV itself is a comorbid condition, though it wasn’t counted as one in this adjusted analysis.

It didn’t matter whether researchers looked at risk for severe outcomes or deaths after removing the significant co-occurring conditions or if they looked at number of chronic illnesses (aside from HIV), said Silvia Bertagnolio, MD, medical officer at the World Health Organization and co-author of the analysis.

“Both models show almost identical [adjusted odds ratios], meaning that HIV was independently significantly associated with severe/critical presentation,” she told this news organization.

As for death, the analysis showed that, overall, people living with HIV were 30% more likely to die of COVID-19 compared with those not living with HIV. And while this held true even when they adjusted the data for comorbidities, people with HIV were more likely to die if they were over age 65 (risk increased by 82%), male (risk increased by 21%), had diabetes (risk increased by 50%), or had hypertension (risk increased by 26%).

When they broke down the data by WHO region – Africa, Europe, the Americas – investigators found that the increased risk for death held true in Africa. But there were not enough data from the other regions to model mortality risk. What’s more, when they broke the data down by country and excluded South Africa, they found that the elevated risk for death in people living with HIV did not reach statistical significance. Dr. Bertagnolio said she suspects that the small sample sizes from other regions made it impossible to detect a difference, but one could still be present.

One thing conspicuously absent from the analysis was information on viral load, CD4 T-cell count, progression of HIV to AIDS, and whether individuals were in HIV care. The first three factors were not reported in the platform, and the fourth was available for 60% of participants but was not included in the analysis. Dr. Bertagnolio pointed out that, for those 60% of participants, 91.8% were on antiretroviral treatment (ART).

“The majority of patients come from South Africa, and we know that in South Africa, over 90% of people receiving ART are virologically suppressed,” she told this news organization. “So we could speculate that this effect persists despite the use of ART, in a population likely to be virally suppressed, although we cannot assess this with certainty through the data set we had.”

A much smaller study of 749 people living with HIV and diagnosed with SARS-CoV-2, also presented at the conference, found that detectable HIV viral load was significantly associated with a slightly higher risk of severe outcomes (P < .039), but CD4 counts less than 200 cells/mm³ was not (P = .15).

And although both Dr. Bertagnolio and conference organizers presented this data as proof that HIV increases the risk for poor COVID-19 outcomes, Dr. Malebranche isn’t so sure. He estimates that only about half his patients have received the COVID-19 vaccine. But this study is unlikely to make him forcefully recommend a COVID-19 vaccination with young, otherwise healthy, and undetectable people in his care who express particular concern about long-term effects of the vaccine. He also manages a lot of people with HIV who have undetectable viral loads and CD4 counts of up to 1,200 but are older, with diabetes, obesity, and high blood pressure. Those are the people he will target with stronger messages regarding the vaccine.

“The young patients who are healthy, virally suppressed, and doing well may very much argue with me, ‘I’m not going to push it,’ but I will bring it up on the next visit,” he said. The analysis “just helps reinforce in me that I need to have these conversations and be a little bit more persuasive to my older patients with comorbid conditions.”

Dr. Bertagnolio has disclosed no relevant financial relationships. Dr. Malebranche serves on the pre-exposure prophylaxis (PrEP) speakers bureau for Gilead Sciences and has consulted and advised for ViiV Healthcare. This study was funded by the World Health Organization.

A version of this article first appeared on Medscape.com.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The amount of prescription drugs given to children in the United States decreased by 27.1% between April and December 2020, compared with the same period in 2019, based on data from a national database.

Overall, dispensing of prescription drugs to all patients in the United States decreased in the wake of COVID-19 but has since rebounded, wrote Kao-Ping Chua, MD, of the University of Michigan, Ann Arbor, and colleagues. “However, whether these same trends occurred for children is unknown.”

In a study published in Pediatrics, the researchers used the IQVIA National Prescription Audit, a database that contains monthly dispensing details from 92% of retail pharmacies in the United States. They compared changes in the dispensing of prescriptions with children aged 0-19 years during 2018-2020.

In the April 2020–December 2020 time period, prescriptions for children aged 1-2 years, 3-9 years, and 10-19 years decreased by 48.7%, 40.6%, and 16.8%, respectively, compared with the same time period in 2019.

The overall dispensing total for children from April 2020 to December 2020 was 160,630,406, representing a 27.1% reduction, compared with the 220,284,613 total from April 2019 to December 2019.

By drug class, prescriptions for antibiotics, ADHD medications, and antidepressants decreased by 55.6%, 11.8%, and 0.1%, respectively, in comparing the two time periods. Prescriptions for drug classes used typically for acute infections decreased by 51.3%, and those used for chronic diseases decreased by 17.4%.

From January 2018 to February 2020, a median of 25,744,758 prescriptions were dispensed to children aged 0-19 years each month. The total prescriptions decreased from 25,684,219 in March 2020 to 16,742,568 in April 2020, increased to 19,657,289 in October 2020, and decreased again to 15,821,914 during December 2020.

In a subgroup analysis, the decline in prescriptions was greater in children aged 0-9 years, compared with those aged 10-19 years. “Because young children have a higher rate of antibiotic use than older children, declines in antibiotic dispensing might affect overall dispensing totals to a greater degree in young children,” the researchers said.

The study findings were limited by several factors including the lack of information on clinical outcomes, disease severity, and details of new versus ongoing prescriptions, as well as the possible heterogeneity in indications within drug classes, and lack of data from small pharmacies, the researchers noted. However, the results were strengthened by the use of a national all-payer database that including most prescriptions dispensed in the United States, and the use of objective measurements of prescribing practices rather than self-reports.

Despite concerns for the decreased dispensing of chronic disease drugs to children during the pandemic, “declines in dispensing of infection-related drugs, such as antitussives and antibiotics, may be welcome developments,” the researchers said. “These declines reveal that substantial reductions in prescribing of these drugs are possible,” and ongoing monitoring is needed to follow whether the reductions continue long term.
 

COVID precautions contributed to prescription declines

The mask-wearing and social distancing imposed by the COVID-19 pandemic has contributed to reduced rates of other illnesses, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

“On the surface, with masks and social isolation, we have seen a drastic reduction in infectious disease,” she said. Fewer infections mean a reduced need for prescriptions to treat them. However, Dr. Kinsella expects the situation to change as more venues and activities open. “I expect that, as things continue to open, we will continue to see more infectious disease,” which will likely lead to more prescription drug use.

Part of the study data were provided through the IQVIA Institute’s Human Data Science Research Collaborative. Lead author Dr. Chua was supported by a career development award from the National Institute on Drug Abuse, but had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

People hospitalized with acute COVID-19 who developed acute severe respiratory distress syndrome (ARDS) had poorer exercise capacity, health-related quality of life, and overall health than the general population a median of 8 months after initial COVID diagnosis, according to a prospective cohort study.

Findings from the cohort, composed of 113 COVID-19 survivors who developed ARDS after admission to a single center before to April 16, 2020, were presented online at the 31st European Congress of Clinical Microbiology & Infectious Diseases by Judit Aranda, MD, from Complex Hospitalari Moisés Broggi in Barcelona.

Median age of the participants was 64 years, and 70% were male. At least one persistent symptom was experienced during follow-up by 81% of the cohort, with 45% reporting shortness of breath, 50% reporting muscle pain, 43% reporting memory impairment, and 46% reporting physical weakness of at least 5 on a 10-point scale.

Of the 104 participants who completed a 6-minute walk test, 30% had a decrease in oxygen saturation level of at least 4%, and 5% had an initial or final level below 88%. Of the 46 participants who underwent a pulmonary function test, 15% had a forced expiratory volume in 1 second below 70%.

And of the 49% of participants with pathologic findings on chest x-ray, most were bilateral interstitial infiltrates (88%).

In addition, more than 90% of participants developed depression, anxiety, or PTSD, Dr. Aranda reported.
 

Not the whole picture

This study shows that sicker people – “those in intensive care units with acute respiratory distress syndrome” – are “more likely to be struggling with more severe symptoms,” said Christopher Terndrup, MD, from the division of general internal medicine and geriatrics at Oregon Health & Science University, Portland.

But a Swiss study, also presented at the meeting, “shows how even mild COVID cases can lead to debilitating symptoms,” Dr. Terndrup said in an interview.

The investigation of long-term COVID symptoms in outpatients was presented online by Florian Desgranges, MD, from Lausanne (Switzerland) University Hospital. He and his colleagues found that more than half of those with a mild to moderate disease had persistent symptoms at least 3 months after diagnosis.

The prevalence of long COVID has varied in previous research, from 15% in a study of health care workers, to 46% in a study of patients with mild COVID, 52% in a study of young COVID outpatients, and 76% in a study of patients hospitalized with COVID.

Dr. Desgranges and colleagues evaluated patients seen in an ED or outpatient clinic from February to April 2020.

The 418 patients with a confirmed COVID-19 diagnosis were compared with a control group of 89 patients who presented to the same centers during the same time frame with similar symptoms – cough, shortness of breath, or fever – but had a negative SARS-CoV-2 test.

The number of patients with comorbidities was similar in the COVID and control groups (34% vs. 36%), as was median age (41 vs. 36 years) and the prevalence of women (62% vs 64%), but the proportion of health care workers was lower in the COVID group (64% vs 82%; P =.006).

Symptoms that persisted for at least 3 months were more common in the COVID than in the control group (53% vs. 37%). And patients in the COVID group reported more symptoms than those in the control group after adjustment for age, gender, smoking status, comorbidities, and timing of the survey phone call.

Levels of sleeping problems and headache were similar in the two groups.

“We have to remember that with COVID-19 came the psychosocial changes of the pandemic situation” Dr. Desgranges said.

This study suggests that some long-COVID symptoms – such as the fatigue, headache, and sleep disorders reported in the control group – could be related to the pandemic itself, which has caused psychosocial distress, Dr. Terndrup said.

Another study that looked at outpatients “has some fantastic long-term follow-up data, and shows that many patients are still engaging in rehabilitation programs nearly a year after their diagnosis,” he explained.
 

The COVID HOME study

That prospective longitudinal COVID HOME study, which assessed long-term symptoms in people who were never hospitalized for COVID, was presented online by Adriana Tami, MD, PhD, from the University Medical Center Groningen (the Netherlands).

The researchers visited the homes of patients to collect data, blood samples, and perform polymerase chain reaction (PCR) testing 1, 2, and 3 weeks after a diagnosis of COVID-19. If their PCR test was still positive, testing continued until week 6 or a negative test. In addition, participants completed questionnaires at week 2 and at months 3, 6 and 12 to assess fatigue, quality of life, and symptoms of depression and anxiety.

Three-month follow-up data were available for 134 of the 276 people initially enrolled in the study. Questionnaires were completed by 85 participants at 3 months, 62 participants at 6 months, and 10 participants at 12 months.

At least 40% of participants reported long-lasting symptoms at some point during follow-up, and at least 30% said they didn’t feel fully recovered at 12 months. The most common symptom was persistent fatigue, reported at 3, 6, and 12 months by at least 44% of participants. Other common symptoms – reported by at least 20% of respondents at 3, 6, and 12 months – were headache, mental or neurologic symptoms, and sleep disorders, shortness of breath, lack of smell or taste, and severe fatigue.

“We have a high proportion of nonhospitalized individuals who suffer from long COVID after more than 12 months,” Dr. Tami concluded, adding that the study is ongoing. “We have other variables that we want to look at, including duration viral shedding and serological results and variants.”

“These cohort studies are very helpful, but they can lead to inaccurate conclusions,” Dr. Terndrup cautioned.

They only provide pieces of the big picture, but they “do add to a growing body of knowledge about a significant portion of COVID patients still struggling with symptoms long after their initial infection. The symptoms can be quite variable but are dominated by both physical and mental fatigue, and tend to be worse in patients who were sicker at initial infection,” he said in an interview.

As a whole, these studies reinforce the need for treatment programs to help patients who suffer from long COVID, he added, but “I advise caution to folks suffering out there who seek ‘miracle cures’; across the world, we are collaborating to find solutions that are safe and effective.”

We are in desperate need of an equity lens in these studies.

“There is still a great deal to learn about long COVID,” said Dr. Terndrup. Data on underrepresented populations – such as Black, Indigenous, and people of color – are lacking from these and others studies, he explained. “We are in desperate need of an equity lens in these studies,” particularly in the United States, where there are “significant disparities” in the treatment of different populations.

However, “I do hope that this work can lead to a better understanding of how other viral infections can cause long-lasting symptoms,” said Dr. Terndrup.

“We have long proposed that after acute presentation, some microbes can cause chronic symptoms, like fatigue and widespread pain. Perhaps we can learn how to better care for these patients after learning from COVID’s significant impact on our societies across the globe.”

Dr. Aranda and Dr. Desgranges have disclosed no relevant financial relationships or study funding. The study by Dr. Tami’s team was funded by the University Medical Center Groningen Organization for Health Research and Development, and Connecting European Cohorts to Increase Common and Effective Response to SARS-CoV-2 Pandemic. Dr. Terndrup disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

People hospitalized with acute COVID-19 who developed acute severe respiratory distress syndrome (ARDS) had poorer exercise capacity, health-related quality of life, and overall health than the general population a median of 8 months after initial COVID diagnosis, according to a prospective cohort study.

Findings from the cohort, composed of 113 COVID-19 survivors who developed ARDS after admission to a single center before to April 16, 2020, were presented online at the 31st European Congress of Clinical Microbiology & Infectious Diseases by Judit Aranda, MD, from Complex Hospitalari Moisés Broggi in Barcelona.

Median age of the participants was 64 years, and 70% were male. At least one persistent symptom was experienced during follow-up by 81% of the cohort, with 45% reporting shortness of breath, 50% reporting muscle pain, 43% reporting memory impairment, and 46% reporting physical weakness of at least 5 on a 10-point scale.

Of the 104 participants who completed a 6-minute walk test, 30% had a decrease in oxygen saturation level of at least 4%, and 5% had an initial or final level below 88%. Of the 46 participants who underwent a pulmonary function test, 15% had a forced expiratory volume in 1 second below 70%.

And of the 49% of participants with pathologic findings on chest x-ray, most were bilateral interstitial infiltrates (88%).

In addition, more than 90% of participants developed depression, anxiety, or PTSD, Dr. Aranda reported.
 

Not the whole picture

This study shows that sicker people – “those in intensive care units with acute respiratory distress syndrome” – are “more likely to be struggling with more severe symptoms,” said Christopher Terndrup, MD, from the division of general internal medicine and geriatrics at Oregon Health & Science University, Portland.

But a Swiss study, also presented at the meeting, “shows how even mild COVID cases can lead to debilitating symptoms,” Dr. Terndrup said in an interview.

The investigation of long-term COVID symptoms in outpatients was presented online by Florian Desgranges, MD, from Lausanne (Switzerland) University Hospital. He and his colleagues found that more than half of those with a mild to moderate disease had persistent symptoms at least 3 months after diagnosis.

The prevalence of long COVID has varied in previous research, from 15% in a study of health care workers, to 46% in a study of patients with mild COVID, 52% in a study of young COVID outpatients, and 76% in a study of patients hospitalized with COVID.

Dr. Desgranges and colleagues evaluated patients seen in an ED or outpatient clinic from February to April 2020.

The 418 patients with a confirmed COVID-19 diagnosis were compared with a control group of 89 patients who presented to the same centers during the same time frame with similar symptoms – cough, shortness of breath, or fever – but had a negative SARS-CoV-2 test.

The number of patients with comorbidities was similar in the COVID and control groups (34% vs. 36%), as was median age (41 vs. 36 years) and the prevalence of women (62% vs 64%), but the proportion of health care workers was lower in the COVID group (64% vs 82%; P =.006).

Symptoms that persisted for at least 3 months were more common in the COVID than in the control group (53% vs. 37%). And patients in the COVID group reported more symptoms than those in the control group after adjustment for age, gender, smoking status, comorbidities, and timing of the survey phone call.

Levels of sleeping problems and headache were similar in the two groups.

“We have to remember that with COVID-19 came the psychosocial changes of the pandemic situation” Dr. Desgranges said.

This study suggests that some long-COVID symptoms – such as the fatigue, headache, and sleep disorders reported in the control group – could be related to the pandemic itself, which has caused psychosocial distress, Dr. Terndrup said.

Another study that looked at outpatients “has some fantastic long-term follow-up data, and shows that many patients are still engaging in rehabilitation programs nearly a year after their diagnosis,” he explained.
 

The COVID HOME study

That prospective longitudinal COVID HOME study, which assessed long-term symptoms in people who were never hospitalized for COVID, was presented online by Adriana Tami, MD, PhD, from the University Medical Center Groningen (the Netherlands).

The researchers visited the homes of patients to collect data, blood samples, and perform polymerase chain reaction (PCR) testing 1, 2, and 3 weeks after a diagnosis of COVID-19. If their PCR test was still positive, testing continued until week 6 or a negative test. In addition, participants completed questionnaires at week 2 and at months 3, 6 and 12 to assess fatigue, quality of life, and symptoms of depression and anxiety.

Three-month follow-up data were available for 134 of the 276 people initially enrolled in the study. Questionnaires were completed by 85 participants at 3 months, 62 participants at 6 months, and 10 participants at 12 months.

At least 40% of participants reported long-lasting symptoms at some point during follow-up, and at least 30% said they didn’t feel fully recovered at 12 months. The most common symptom was persistent fatigue, reported at 3, 6, and 12 months by at least 44% of participants. Other common symptoms – reported by at least 20% of respondents at 3, 6, and 12 months – were headache, mental or neurologic symptoms, and sleep disorders, shortness of breath, lack of smell or taste, and severe fatigue.

“We have a high proportion of nonhospitalized individuals who suffer from long COVID after more than 12 months,” Dr. Tami concluded, adding that the study is ongoing. “We have other variables that we want to look at, including duration viral shedding and serological results and variants.”

“These cohort studies are very helpful, but they can lead to inaccurate conclusions,” Dr. Terndrup cautioned.

They only provide pieces of the big picture, but they “do add to a growing body of knowledge about a significant portion of COVID patients still struggling with symptoms long after their initial infection. The symptoms can be quite variable but are dominated by both physical and mental fatigue, and tend to be worse in patients who were sicker at initial infection,” he said in an interview.

As a whole, these studies reinforce the need for treatment programs to help patients who suffer from long COVID, he added, but “I advise caution to folks suffering out there who seek ‘miracle cures’; across the world, we are collaborating to find solutions that are safe and effective.”

We are in desperate need of an equity lens in these studies.

“There is still a great deal to learn about long COVID,” said Dr. Terndrup. Data on underrepresented populations – such as Black, Indigenous, and people of color – are lacking from these and others studies, he explained. “We are in desperate need of an equity lens in these studies,” particularly in the United States, where there are “significant disparities” in the treatment of different populations.

However, “I do hope that this work can lead to a better understanding of how other viral infections can cause long-lasting symptoms,” said Dr. Terndrup.

“We have long proposed that after acute presentation, some microbes can cause chronic symptoms, like fatigue and widespread pain. Perhaps we can learn how to better care for these patients after learning from COVID’s significant impact on our societies across the globe.”

Dr. Aranda and Dr. Desgranges have disclosed no relevant financial relationships or study funding. The study by Dr. Tami’s team was funded by the University Medical Center Groningen Organization for Health Research and Development, and Connecting European Cohorts to Increase Common and Effective Response to SARS-CoV-2 Pandemic. Dr. Terndrup disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

People hospitalized with acute COVID-19 who developed acute severe respiratory distress syndrome (ARDS) had poorer exercise capacity, health-related quality of life, and overall health than the general population a median of 8 months after initial COVID diagnosis, according to a prospective cohort study.

Findings from the cohort, composed of 113 COVID-19 survivors who developed ARDS after admission to a single center before to April 16, 2020, were presented online at the 31st European Congress of Clinical Microbiology & Infectious Diseases by Judit Aranda, MD, from Complex Hospitalari Moisés Broggi in Barcelona.

Median age of the participants was 64 years, and 70% were male. At least one persistent symptom was experienced during follow-up by 81% of the cohort, with 45% reporting shortness of breath, 50% reporting muscle pain, 43% reporting memory impairment, and 46% reporting physical weakness of at least 5 on a 10-point scale.

Of the 104 participants who completed a 6-minute walk test, 30% had a decrease in oxygen saturation level of at least 4%, and 5% had an initial or final level below 88%. Of the 46 participants who underwent a pulmonary function test, 15% had a forced expiratory volume in 1 second below 70%.

And of the 49% of participants with pathologic findings on chest x-ray, most were bilateral interstitial infiltrates (88%).

In addition, more than 90% of participants developed depression, anxiety, or PTSD, Dr. Aranda reported.
 

Not the whole picture

This study shows that sicker people – “those in intensive care units with acute respiratory distress syndrome” – are “more likely to be struggling with more severe symptoms,” said Christopher Terndrup, MD, from the division of general internal medicine and geriatrics at Oregon Health & Science University, Portland.

But a Swiss study, also presented at the meeting, “shows how even mild COVID cases can lead to debilitating symptoms,” Dr. Terndrup said in an interview.

The investigation of long-term COVID symptoms in outpatients was presented online by Florian Desgranges, MD, from Lausanne (Switzerland) University Hospital. He and his colleagues found that more than half of those with a mild to moderate disease had persistent symptoms at least 3 months after diagnosis.

The prevalence of long COVID has varied in previous research, from 15% in a study of health care workers, to 46% in a study of patients with mild COVID, 52% in a study of young COVID outpatients, and 76% in a study of patients hospitalized with COVID.

Dr. Desgranges and colleagues evaluated patients seen in an ED or outpatient clinic from February to April 2020.

The 418 patients with a confirmed COVID-19 diagnosis were compared with a control group of 89 patients who presented to the same centers during the same time frame with similar symptoms – cough, shortness of breath, or fever – but had a negative SARS-CoV-2 test.

The number of patients with comorbidities was similar in the COVID and control groups (34% vs. 36%), as was median age (41 vs. 36 years) and the prevalence of women (62% vs 64%), but the proportion of health care workers was lower in the COVID group (64% vs 82%; P =.006).

Symptoms that persisted for at least 3 months were more common in the COVID than in the control group (53% vs. 37%). And patients in the COVID group reported more symptoms than those in the control group after adjustment for age, gender, smoking status, comorbidities, and timing of the survey phone call.

Levels of sleeping problems and headache were similar in the two groups.

“We have to remember that with COVID-19 came the psychosocial changes of the pandemic situation” Dr. Desgranges said.

This study suggests that some long-COVID symptoms – such as the fatigue, headache, and sleep disorders reported in the control group – could be related to the pandemic itself, which has caused psychosocial distress, Dr. Terndrup said.

Another study that looked at outpatients “has some fantastic long-term follow-up data, and shows that many patients are still engaging in rehabilitation programs nearly a year after their diagnosis,” he explained.
 

The COVID HOME study

That prospective longitudinal COVID HOME study, which assessed long-term symptoms in people who were never hospitalized for COVID, was presented online by Adriana Tami, MD, PhD, from the University Medical Center Groningen (the Netherlands).

The researchers visited the homes of patients to collect data, blood samples, and perform polymerase chain reaction (PCR) testing 1, 2, and 3 weeks after a diagnosis of COVID-19. If their PCR test was still positive, testing continued until week 6 or a negative test. In addition, participants completed questionnaires at week 2 and at months 3, 6 and 12 to assess fatigue, quality of life, and symptoms of depression and anxiety.

Three-month follow-up data were available for 134 of the 276 people initially enrolled in the study. Questionnaires were completed by 85 participants at 3 months, 62 participants at 6 months, and 10 participants at 12 months.

At least 40% of participants reported long-lasting symptoms at some point during follow-up, and at least 30% said they didn’t feel fully recovered at 12 months. The most common symptom was persistent fatigue, reported at 3, 6, and 12 months by at least 44% of participants. Other common symptoms – reported by at least 20% of respondents at 3, 6, and 12 months – were headache, mental or neurologic symptoms, and sleep disorders, shortness of breath, lack of smell or taste, and severe fatigue.

“We have a high proportion of nonhospitalized individuals who suffer from long COVID after more than 12 months,” Dr. Tami concluded, adding that the study is ongoing. “We have other variables that we want to look at, including duration viral shedding and serological results and variants.”

“These cohort studies are very helpful, but they can lead to inaccurate conclusions,” Dr. Terndrup cautioned.

They only provide pieces of the big picture, but they “do add to a growing body of knowledge about a significant portion of COVID patients still struggling with symptoms long after their initial infection. The symptoms can be quite variable but are dominated by both physical and mental fatigue, and tend to be worse in patients who were sicker at initial infection,” he said in an interview.

As a whole, these studies reinforce the need for treatment programs to help patients who suffer from long COVID, he added, but “I advise caution to folks suffering out there who seek ‘miracle cures’; across the world, we are collaborating to find solutions that are safe and effective.”

We are in desperate need of an equity lens in these studies.

“There is still a great deal to learn about long COVID,” said Dr. Terndrup. Data on underrepresented populations – such as Black, Indigenous, and people of color – are lacking from these and others studies, he explained. “We are in desperate need of an equity lens in these studies,” particularly in the United States, where there are “significant disparities” in the treatment of different populations.

However, “I do hope that this work can lead to a better understanding of how other viral infections can cause long-lasting symptoms,” said Dr. Terndrup.

“We have long proposed that after acute presentation, some microbes can cause chronic symptoms, like fatigue and widespread pain. Perhaps we can learn how to better care for these patients after learning from COVID’s significant impact on our societies across the globe.”

Dr. Aranda and Dr. Desgranges have disclosed no relevant financial relationships or study funding. The study by Dr. Tami’s team was funded by the University Medical Center Groningen Organization for Health Research and Development, and Connecting European Cohorts to Increase Common and Effective Response to SARS-CoV-2 Pandemic. Dr. Terndrup disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

A version of this article first appeared on Medscape.com.

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

A version of this article first appeared on Medscape.com.

Thoughtful, targeted approaches are needed to increase COVID-19 vaccination rates in Black and Latinx communities, which often distrust the health care system and face barriers to vaccine access, new data show.

“Black, Latinx, and Native American individuals represent about a combined 60% of COVID-19 deaths, despite comprising significantly less of the United States population,” said Jacinda C. Abdul-Mutakabbir, PharmD, from Loma Linda (Calif.) University.

“To put this into perspective, Black individuals represent 13.4% of the United States population, while Native Americans represent 1.6%, clearly showing the disproportionate outcomes here,” she explained during her online presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

The vaccine creates an opportunity to change the disproportionate way COVID-19 has affected racial and ethnic communities, said Dr. Abdul-Mutakabbir, but “a long history of mistreatment within the U.S. health care system decreases their trust for the system to use fair practices when delivering these vaccines.”

For people in minority communities, often “the fear of cost associated with health care keeps them from being vaccinated,” she said. “Also, there is a lack of vaccines actually allocated to these communities, or inconsistent computer-based sign-ups that make WiFi mandatory, which in turn has created additional barriers for vaccination access.”

Loma Linda University maintains the largest mass-vaccination site in San Bernardino County, the fourth-largest county in southern California. However, only 3.0% of the people vaccinated there have been Black. And although 8% of the state’s population is Black, only 2.7% of the Black population has been vaccinated.

In contrast, Black Californians have accounted for about 20% of COVID-19 cases in the state, and 20%-30% of COVID-19 deaths.

To promote equitable access to COVID-19 vaccines, Dr. Abdul-Mutakabbir and colleagues developed a “three-tiered approach.” First, they had local Black faith leaders hold summits ahead of the vaccination clinics. Next, at those summits, they had a Black pharmacist educate attendees about the vaccines. And finally, they held a low-barrier community vaccination clinic in a Black community, where the pharmacist oversaw the transport and preparation of the vaccines.

Because access, transportation, and internet are all barriers to vaccination, the clinic used paper-based registration and was held as a pop-up clinic at a local Black church. The team held two clinics for the first Moderna dose, one clinic for the second Moderna dose, and one clinic for the Johnson & Johnson one-dose vaccine.

During the Moderna first-dose clinics, 673 vaccinations were administered, and during the second-dose clinic, 366 were administered. Early data showed a return rate of 87%, but the team has yet to update the final numbers, Dr. Abdul-Mutakabbir reported. During the Johnson & Johnson clinic, 314 vaccinations were administered, nearly half to Black people. After the community vaccination clinics, the mass vaccination site saw a 0.6% increase in vaccinations for Black people.

Dr. Abdul-Mutakabbir’s team also held three community clinics in Latinx communities. During the first-dose Moderna pop-up clinic, 258 vaccinations were administered, and during the second-dose clinic, 253 were, for a 98% return rate. Approximately 92% of those vaccinated were Latinx. 

The study findings are not surprising, said Rhea Boyd, MD, director of equity and justice for California Children’s Trust.

“The barriers to vaccination are known and clear,” she said in an interview. “Mobile clinics with paper appointments address a number of those barriers head on, like transportation, internet access, and accessibility. Having Black providers leading the effort and church leaders involved also has been shown to increase confidence in the operations and process.”

Information campaigns can help counter online disinformation. Ultimately, however, “the main barrier to vaccination is access,” Dr. Boyd said. “Address access and rates will increase.”

The health inequities seen in vaccination rates among Black and Latinx people “are a product of structural and systemic racism,” Dr. Abdul-Mutakabbir said. “To create equitable processes, it is essential that we evaluate how we approach each of these different minoritized groups.”

Dr. Abdul-Mutakabbir disclosed no relevant financial relationships. Dr. Boyd codeveloped THE CONVERSATION, a national campaign to bring credible information about the COVID vaccines to Black and Latinx communities in partnership with KFF, BCAC, and Unidos US.

A version of this article first appeared on Medscape.com.

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A lack of consensus in the evidence regarding the antiviral remdesivir (Veklury) to treat people with COVID-19 continues, leaving clinicians without clear direction on one of the few treatments for the illness approved under U.S. Food and Drug Administration emergency use authorization.

The latest research comes from Michael Ohl, MD, MSPH, and colleagues, who studied a large group of VA patients hospitalized with COVID-19. Compared with a matched group of veterans who did not receive the antiviral, remdesivir did not significantly improve survival.

The percentages were close: 12.2% of patients in the remdesivir group died within 30 days compared with 10.6% of those in the control group.

At the same time, the retrospective cohort study showed remdesivir was associated with more days in the hospital.

“There is still uncertainty about the role of remdesivir in treatment for people hospitalized with COVID-19,” Dr. Ohl told this news organization.

“It is reasonable to follow the CDC and Infectious Diseases Society of America guidelines for remdesivir use, “but clinicians should avoid admitting people or keeping people in the hospital solely to receive remdesivir if they do not meet other criteria for hospitalization,” said Dr. Ohl, lead author and an infectious disease specialist at the Center for Access & Delivery Research and Evaluation, Iowa City Veterans Affairs (VA) Health Care System.

The study was published online July 15 in JAMA Network Open.
 

Sticking with the official protocol?

The longer a hospital stays associated with remdesivir, a median 6 days versus 3 days, could be a result of treating people for 5 or 10 days with the antiviral agent. In other words, it is “possible that clinicians were not discharging patients who otherwise met the criteria for hospital discharge until the remdesivir course was completed,” Dr. Ohl and colleagues note.

Not doing so, they add, could have resulted in “increased used of scarce hospital beds during the pandemic.”

“The recommended remdesivir treatment course is a somewhat arbitrary 5 or 10 days depending on illness severity, and remdesivir is currently available only as an intravenous formulation for use in health care settings,” they add.

This is the “most likely explanation,” notes Gio J. Baracco, MD, in an invited commentary accompanying the study.

At the time of the study, use of remdesivir also required patient consent, close adverse event monitoring, and ongoing testing, Dr. Baracco notes.

He added that an option to discharge patients earlier if they responded to treatment might have been lost in translation from clinical trial protocol to real-world use in the VA system.

While a large clinical trial protocol called for the remdesivir infusions to be stopped early if the patient met the primary outcome and was ready to be discharged, “this detail was not adequately translated to the clinicians treating these patients,” added Dr. Baracco, who’s with the Division of Infectious Diseases at the University of Miami Miller School of Medicine and the Miami VA Healthcare System.
 

Conflicting evidence

Another large study, the World Health Organization Solidarity Trial, found remdesivir was not associated with shorter hospital stays or improved survival compared with standard of care. For this reason, the WHO recommends against use of remdesivir.

In contrast, the double-blind, randomized Adaptive COVID-19 Treatment Trial (ACTT-1) linked remdesivir treatment to shorter stays in the hospital, a median 10 days versus 15 days in a placebo group.

The FDA included the 2020 ACTT-1 in its consideration for remdesivir emergency use authorization. The FDA issued the EUA in May 2020, followed by full approval as the first treatment indicated for COVID-19 in October.

ACTT-1 lead author John H. Beigel, MD, and colleagues also looked at the death rates for remdesivir versus placebo.

By day 15, the proportion of people who died was 6.7% in the remdesivir group versus 11%. By day 29, the rate was 11.4% among those who received the antiviral versus 15.2% among those who did not.

When asked why the VA and ACTT-1 studies yielded different results, Dr. Beigel cited two reasons. The timing was different, with the VA study starting after the remdesivir EUA was issued, and ACTT-1 findings were announced.

“So at that point, clinicians understood those populations most likely to benefit from remdesivir. The use of remdesivir likely did not occur at random; it was likely to be more commonly used in those who were sicker or at higher risk for poor outcomes,” said Dr. Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID).

In addition, the studies evaluated very different populations, he said. The differences in median duration of hospitalization between the trials reflects this, Dr. Beigel added.

Furthermore, when asked if he thinks the new evidence should affect clinical use of remdesivir, Dr. Beigel replied, “No. Observational studies, even with adjustments such as propensity score matching, are not equivalent levels of proof compared to randomized trials.”
 

Study details

Dr. Ohl and colleagues identified patients admitted to one of 123 VA hospitals for the first time for COVID-19 from May 1 to Oct. 8, 2020. Each had a PCR-confirmed SARS-CoV-2 infection. The researchers then compared 1,172 patients receiving remdesivir to another 1,172 patients not receiving the agent.

Those receiving remdesivir were more likely to be older, White, have chronic obstructive pulmonary disease and have more severe COVID-19. A total 94% of the remdesivir group were men.

“Over 90% of the people included in VA study were men, mostly over the age of 60,” Dr. Ohl said when asked how generalizable the findings would be to a non-VA population.

“There is no obvious biological reason that remdesivir should have different effects in men and women, but we should be cautious about extrapolating study findings to women and younger individuals,” he added.

Limitations of the study include its observational design, which makes unadjusted confounding based on illness severity a possibility. In addition, the investigators were unable to identify specific subgroups that might benefit from remdesivir treatment.

The data did suggest that remdesivir was more effective earlier in the course of disease when patients required supplemental oxygen and before need for mechanical ventilation.

Dr. Baracco pointed out the contradictory findings in his commentary: “The real-life application of a drug promising to hasten discharge from the hospital as its primary beneficial outcome must include an assessment of how easy it is to do so and make it clear that once a patient reaches that point, they can discontinue the drug.”

“The paradoxical findings in the study by Dr. Ohl et al. compared with the study used for its authorization illustrate this point very clearly,” he adds.

Dr. Ohl reported receiving grants from Veterans Affairs Health Services Research and Development during the conduct of the study and consulting for Gilead Pharmaceuticals outside the submitted work. Dr. Baracco reported receiving salary support from the U.S. Department of Veterans Affairs. Dr. Beigel has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

A version of this article first appeared on Medscape.com.

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

A version of this article first appeared on Medscape.com.

A homeopathic doctor licensed in California was arrested July 14 and charged with a scheme to sell homeoprophylaxis immunization pellets and to falsify COVID-19 vaccination cards by making it appear that her customers had received the Moderna vaccine, according to the U.S. Department of Justice.

Juli A. Mazi, 41, of Napa, is charged with one count of wire fraud and one count of false statements related to health care matters. The case is the first federal criminal fraud prosecution related to homeoprophylaxis immunizations and fraudulent vaccination record cards, the DOJ said in a news release.

In April, according to federal authorities, an individual submitted a complaint to the Department of Health and Human Services Office of Inspector General, stating that family members had purchased the immunization pellets from Ms. Mazi. The complainant stated that the family members had told her/him that Ms. Mazi had said the pellets contained the COVID-19 virus and would create an antibody response in the immune system.

The affidavit noted that none of the family members had received injections of any of the COVID-19 vaccines authorized by the Food and Drug Administration.

However, the complainant said, Ms. Mazi sent COVID-19 vaccination cards listing Moderna to the complainant family. Ms. Mazi allegedly instructed the family members to mark the cards to falsely state that they had received the Moderna vaccine on the date that they ingested the homeoprophylaxis immunization pellets.

She also allegedly provided instructions on how to fraudulently complete the cards to make it appear that a customer had received two doses of the Moderna vaccine. She even supplied Moderna lot numbers to enter on the cards.

In addition, Ms. Mazi allegedly offered homeoprophylaxis immunizations for childhood illnesses that she falsely claimed would satisfy the immunization requirements for California schools, and falsified immunization cards that were submitted by parents to California schools.

Ms. Mazi further stated that her customers could provide the pellets to children for COVID-19 immunity, and that “the dose is actually the same for babies,” the news release said.

Ms. Mazi is alleged to have falsely claimed that ingesting the pellets would result in full lifelong immunity from COVID-19. In addition, she exploited the disinformation and fear surrounding COVID-19 vaccination by falsely claiming that the FDA-authorized vaccines contain “toxic ingredients,” the DOJ said.
 

Homeopathic preparations

According to the DOJ, “Homeophrophylaxis involves the exposure of an individual to dilute amounts of a disease, purportedly to stimulate the immune system and confer immunity.”

According to Australia’s National Centre for Immunisation Research & Surveillance (NCIRS), a private organization funded by the Australian and New South Wales governments, there is no high-quality research showing that homeopathic preparations are effective in preventing infectious disease.

Typical homeopathic preparations dilute a disease, tissue, or plant extract in water “to the point where none of the original material is contained within the preparation by the end of the process,” an NCIRS fact sheet says.

Referring to Ms. Mazi, Deputy Attorney General Lisa Monaco said in the news release, “This defendant allegedly defrauded and endangered the public by preying on fears and spreading misinformation about FDA-authorized vaccinations, while also peddling fake treatments that put people’s lives at risk.

“Even worse, the defendant allegedly created counterfeit COVID-19 vaccination cards and instructed her customers to falsely mark that they had received a vaccine, allowing them to circumvent efforts to contain the spread of the disease.”

The case against Ms. Mazi was brought in coordination with the DOJ Health Care Fraud Unit’s COVID-19 Interagency Working Group, which organizes efforts to address illegal activity involving health care programs during the pandemic.

The fraud unit leads the department’s Health Care Fraud Strike Force, which has existed since 2007. In May, U.S. Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force in partnership with other government agencies to combat and prevent pandemic-related fraud.

A version of this article first appeared on Medscape.com.

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After acute SARS-CoV-2 infection, patients report lingering malnutrition, loss of appetite, and failure to regain lost weight long after other gastrointestinal and non-GI symptoms have resolved, according to the results of a new study.

In the large, multicenter retrospective study published online in Clinical Gastroenterology and Hepatology, Anam Rizvi, MD, and colleagues at Long Island Jewish Medical Center, in New Hyde Park (N.Y.), report a high prevalence of GI symptoms among patients with COVID-19.

They followed 17,462 adult patients who were hospitalized for severe COVID-19 between March 2020 and January 2021. Of these, 3,229 (18.5%) also had GI symptoms.

The median age of the patients was 66 years, and 46.9% were women. The diverse population included White (46%), Black (23%), and Hispanic (17%) patients admitted to 12 medical centers of the Northwell Health System in Manhattan, Queens, Long Island, and Staten Island. The researchers followed patients for 3 months (88.7%) and 6 months (56.5%).

The most frequent initial GI symptoms were gastroenteritis (52.5%), malnutrition (23%), GI bleeding (20.4%), and idiopathic pancreatitis (0.5%). Notably, 50.6% of those with GI manifestations reported an inability to regain lost weight at 3 months; 32.4% reported failure to regain lost weight at 6 months.

These percentages rose among patients with malnutrition, as determined by a board-certified in-hospital nutritionist; 56.4% failed to gain weight at 6 months. A median 14.7-lb weight loss persisted at the half-year mark.

In contrast to these lingering symptoms, gastroenteritis, GI bleeding, and pancreatitis all resolved by 3 months post hospitalization.

“We were somewhat shocked that the prevalence of these symptoms was so high, but it’s overall reassuring that most GI symptoms of COVID-19 resolve,” study author Arvind J. Trindade, MD, told this news organization. “In some COVID patients, we’re seeing an inability to gain weight without diarrhea or postinfectious irritable bowel syndrome.

“Patients with an inability to regain weight should consider follow-up with a nutritionist,” continued Dr. Trindade, who is the center’s director of endoscopy and an associate professor at the Feinstein Institutes for Medical Research, in Manhasset (N.Y.). His group also recommends developing malnutrition screening assessments for COVID-19 patients who recover from the acute infection.

The study was prompted by clinical observations during follow-up.

“We saw that a lot of these patients had trouble regaining weight, but we still don’t know why,” Dr. Trindade said. There were no discriminating clinical features apart from malnutrition that indicated an increased risk, and no socioeconomic or demographic characteristics. “We also looked at whether any factors predicted malnutrition, and there weren’t any that would predispose to malnutrition,” he added.

“We’re now reaching out to nonclinical investigators to see if there’s an interest in studying the underlying science behind these symptoms,” Dr. Trindade said.

His group plans to release 12-month follow-up data from the second wave of the pandemic in January 2022.

Initial GI symptoms are thought to be due to the virus’s S1 spike protein’s binding to the angiotensin-converting enzyme 2 receptors, which are abundant in GI epithelial cells. “But why patients have long-term GI sequelae is probably a whole different physiological mechanism,” Dr. Trindade said. “The thought is that there has to be some hormone or pathway that doesn’t allow them to regain weight.”

“The hospital cohort by [Dr. Rizvi] and colleagues is unique and helpful in that patients with GI symptoms are less likely to be hospitalized, and perhaps those patients who are sick enough for admission to the hospital who also have GI symptoms need specific attention paid to their appetite, weight, and nutritional status,” said Jordan M. Shapiro, MD, who commented on the study but was not involved in it.

The constellations of GI symptoms are difficult to distinguish from other postinfectious GI syndromes, such as irritable bowel syndrome and gastroparesis, added Dr. Shapiro, an assistant professor of medicine in gastroenterology and hepatology at Baylor College of Medicine, Houston. “We’re still unpacking what is and is not specific to post–COVID-19 GI symptoms. Prospective studies are necessary to further study this phenomenon.”

Last year, a small Italian study documented significant weight loss and malnutrition in a hospital cohort of 213 discharged COVID-19 patients. In that study, the duration of disease was predictive of weight loss.

The authors note several study limitations, including that the cohort was limited to hospitalized patients from New York and that the 6-month follow-up period was short.

The study received no funding. Dr. Trindade serves as a consultant to Pentax Medical. All other authors and Dr. Shapiro have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

A version of this article first appeared on Medscape.com.

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

A version of this article first appeared on Medscape.com.

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

A version of this article first appeared on Medscape.com.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

A version of this article first appeared on Medscape.com.

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

A version of this article first appeared on Medscape.com.

Early treatment with low-molecular-weight heparin (LMWH) reduces the risk for death in patients with COVID-19, a retrospective cohort study shows.

Heparin could reduce the risk for blood clots, Andrea De Vito, MD, of the unit of infectious diseases at the University of Sassari, Italy, said during his online presentation of the findings at the 31st European Congress of Clinical Microbiology & Infectious Diseases.

“Several studies try to describe the role played by coagulopathies in COVID-19 death,” but the mechanism causing them is still unclear, Dr. De Vito explained.

Some guidelines have suggested heparin as a treatment for hospitalized COVID-19 patients, but few have looked at nonhospitalized patients. In fact, the National Institutes of Health discourages the use of heparin in nonhospitalized COVID-19 patients, and guidance for the home care of COVID-19 patients from the World Health Organization doesn’t mention heparin treatment at all, he said.

To examine the benefits of early heparin – whether administered at home or in the hospital – Dr. De Vito and colleagues looked at a cohort of older adults with COVID-19 who were evaluated or treated at an Italian university hospital.

“Some patients were hospitalized immediately after symptoms onset; other people preferred to call their general practitioner and started the treatment at home,” Dr. De Vito said in an interview. “Other people were hospitalized for worsening of symptoms later in the course of the disease.”

Of the 734 patients, 296 received heparin within 5 days of the onset of symptoms or a positive COVID-19 test. Of the remaining 438 patients, 196 received LMWH treatment later during the disease course, and the rest never received LMWH.

All patients who received early heparin were treated with LMWH 4,000 IU, or 6,000 IU if their body mass index was above 30 kg/m². This was reduced to 2,000 IU if estimated glomerular filtration rate (eGFR) dropped below 30 mL/min. None of the patients had previously received heparin.

Median age was slightly younger for patients who received early heparin than for those who did not (76.8 vs. 78.5 years).

Other demographic characteristics, such as sex and BMI, were similar in the two groups, as were rates of comorbidities, such as hypertension, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, kidney disease, and neurologic conditions. Also similar were the frequency of symptoms (such as fever, cough, and shortness of breath) and rates of treatment with remdesivir or steroids.

Rates of hospital admission were not significantly different between patients who received early heparin and those who did not (65% vs. 61%). There was also no significant difference in use of a venturi mask (35% vs. 28%), noninvasive ventilation (13% vs. 14%), or intubation (5% vs. 8%).

However, rates of death were significantly lower in patients who received early heparin than in those who did not (13% vs. 25%; P < .0001).

There was a trend toward shorter hospital stays for patients treated with early heparin, but the difference was not significant (median, 10 vs. 13 days; P = .08).

Researchers also conducted a separate analysis of 219 COVID-19 patients who received LMWH at home, regardless of when during their disease course they received it. These patients were significantly less likely to be hospitalized than were patients who did not receive LMWH at home (odds ratio, 0.2; P < .0001).

Comparatively, early heparin treatment had a greater effect on the risk for death and the risk for hospitalization than did other factors.

“Thromboemboli are a major complication of COVID. There is good consensus that hospitalized patients with COVID should receive anticoagulants prophylactically, although the best dose is being studied,” said Judy Stone, MD, an infectious disease physician and journalist who was not involved in the study.

“This study extends those findings of benefit from anticoagulants to nonhospitalized patients, with fewer deaths in those treated with low-molecular-weight heparin,” Dr. Stone told this news organization. “The major limitation is that the study is retrospective and observational. The next step would be to confirm these findings prospectively, randomizing a similar group to LMWH or no anticoagulation.”

Another limitation of the study is that some of the patients lived in nursing homes and might have received care from nurses that eliminated the need for hospitalization, Dr. De Vito added.

The study did not note any external funding. The authors have disclosed no relevant financial relationships. Dr. Stone is a member of the advisory committee for the C-Path CURE Drug Repurposing Collaboratory (CDRC) program and has written for Medscape.

A version of this article first appeared on Medscape.com.