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20% of U.S. COVID-19 deaths were aged 20-64 years
*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20% of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.
A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years.
The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease.
To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.
Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”
But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report.
The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.
Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.
Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.
More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.
SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.
*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20% of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.
A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years.
The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease.
To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.
Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”
But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report.
The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.
Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.
Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.
More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.
SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.
*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20% of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.
A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years.
The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease.
To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.
Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”
But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report.
The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.
Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.
Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.
More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.
SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.
Real-world shortages not addressed in new COVID-19 guidance
Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.
While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.
The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).
“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.
While the WHO guidance does provide solid facts to support best practices for managing COVID-19, providers will also need to look beyond the document to tackle real-world issues, said David M. Ferraro, MD, FCCP, a pulmonary and critical care physician and associate professor of medicine at National Jewish Health in Denver.
For example, while the guidelines address the importance of screening and triage, limited COVID-19 testing may be a barrier to timely diagnoses that might compel more individuals to comply with social distancing recommendations, according to Dr. Ferraro, vice chair of the Fundamental Disaster Management Committee for the Society of Critical Care Medicine (SCCM).
“If we’re not providing people with confirmation that they have the virus, they may potentially continue to be spreaders of the disease, because they don’t have that absolute proof,” Dr. Ferraro said in an interview. “I think that’s where we are limited right now, because often we’re not able to tell the mild symptomatic people – or even the asymptomatic people – that they really need to play a role in preventing further spread.”
Likewise, the guidelines provide sound guidance on management of severe or critical COVID-19, according to Dr. Ferraro, yet they don’t address the potential for shortages of trained health care personnel to handle more severe cases requiring ventilation. That’s clearly an important issue, he said, especially with recent reports that the COVID-19 pandemic has pushed Italian intensive care units (ICUs) to the brink of collapse.
If the pandemic reaches crisis levels in the United States, nearly 1 million people would need ventilatory support, according to a recent report from SCCM on U.S. resource availability for COVID-19. And while there are an estimated 200,000 ventilators available in the United States, it’s estimated in that report that only 135,000 patients could be handled at a time, given the shortage of ICU physicians, advanced practice providers, nurses, and respiratory therapists with training in mechanical ventilation.
“If our ICUs get overwhelmed and swarmed, we may have the technology available, but we may not have enough resources and personnel to safely manage the number of patients,” Dr. Ferraro said.
The solution to that, according to the SCCM report, is to focus on expanding the pool of trained professionals who may be needed, not only to mechanically ventilate patients with COVID-19, but also to care for other critically ill patients routinely cared for in the ICU. They also suggest adopting a “tiered staffing strategy” in which non-ICU trained health care providers augment the capacity of experienced ICU staff.
With the prospect of untrained health care workers in mind, the WHO guidance could be a valuable resource for those who do have to jump into ICU roles, according to Dr. Ferraro.
The WHO also stresses immediate implementation of appropriate measures for infection prevention and control (IPC). According to their guidance, IPC needs to be initiated right at the point where the patient enters the hospital, with screening done at the first point of contact in the emergency department or outpatient clinics.
If patients are suspected to have COVID-19, they should receive a mask, and should be directed to a separate area where they are kept at least 1 meter apart from other individuals with suspected COVID-19, according to the WHO. (The Centers for Disease Control and Prevention recommends maintaining a distance of 6 feet to prevent spread of illness).
Beyond standard precautions such as hand washing and use of personal protective equipment, health care workers should do a point-of-care risk assessment at every patient contact to determine whether additional precautions are required.
Having standard IPC measures in place is “paramount,” according to Dr. Ferraro, for a disease that has no available vaccine, no proven treatments, and a stealthy spread fueled by asymptomatic carriers.
“Those are huge weapons against us, and the only thing we really have to knock this down is really infection prevention control, so that truly is at the cornerstone,” he said. “These are things that we must strictly follow.”
Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.
While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.
The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).
“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.
While the WHO guidance does provide solid facts to support best practices for managing COVID-19, providers will also need to look beyond the document to tackle real-world issues, said David M. Ferraro, MD, FCCP, a pulmonary and critical care physician and associate professor of medicine at National Jewish Health in Denver.
For example, while the guidelines address the importance of screening and triage, limited COVID-19 testing may be a barrier to timely diagnoses that might compel more individuals to comply with social distancing recommendations, according to Dr. Ferraro, vice chair of the Fundamental Disaster Management Committee for the Society of Critical Care Medicine (SCCM).
“If we’re not providing people with confirmation that they have the virus, they may potentially continue to be spreaders of the disease, because they don’t have that absolute proof,” Dr. Ferraro said in an interview. “I think that’s where we are limited right now, because often we’re not able to tell the mild symptomatic people – or even the asymptomatic people – that they really need to play a role in preventing further spread.”
Likewise, the guidelines provide sound guidance on management of severe or critical COVID-19, according to Dr. Ferraro, yet they don’t address the potential for shortages of trained health care personnel to handle more severe cases requiring ventilation. That’s clearly an important issue, he said, especially with recent reports that the COVID-19 pandemic has pushed Italian intensive care units (ICUs) to the brink of collapse.
If the pandemic reaches crisis levels in the United States, nearly 1 million people would need ventilatory support, according to a recent report from SCCM on U.S. resource availability for COVID-19. And while there are an estimated 200,000 ventilators available in the United States, it’s estimated in that report that only 135,000 patients could be handled at a time, given the shortage of ICU physicians, advanced practice providers, nurses, and respiratory therapists with training in mechanical ventilation.
“If our ICUs get overwhelmed and swarmed, we may have the technology available, but we may not have enough resources and personnel to safely manage the number of patients,” Dr. Ferraro said.
The solution to that, according to the SCCM report, is to focus on expanding the pool of trained professionals who may be needed, not only to mechanically ventilate patients with COVID-19, but also to care for other critically ill patients routinely cared for in the ICU. They also suggest adopting a “tiered staffing strategy” in which non-ICU trained health care providers augment the capacity of experienced ICU staff.
With the prospect of untrained health care workers in mind, the WHO guidance could be a valuable resource for those who do have to jump into ICU roles, according to Dr. Ferraro.
The WHO also stresses immediate implementation of appropriate measures for infection prevention and control (IPC). According to their guidance, IPC needs to be initiated right at the point where the patient enters the hospital, with screening done at the first point of contact in the emergency department or outpatient clinics.
If patients are suspected to have COVID-19, they should receive a mask, and should be directed to a separate area where they are kept at least 1 meter apart from other individuals with suspected COVID-19, according to the WHO. (The Centers for Disease Control and Prevention recommends maintaining a distance of 6 feet to prevent spread of illness).
Beyond standard precautions such as hand washing and use of personal protective equipment, health care workers should do a point-of-care risk assessment at every patient contact to determine whether additional precautions are required.
Having standard IPC measures in place is “paramount,” according to Dr. Ferraro, for a disease that has no available vaccine, no proven treatments, and a stealthy spread fueled by asymptomatic carriers.
“Those are huge weapons against us, and the only thing we really have to knock this down is really infection prevention control, so that truly is at the cornerstone,” he said. “These are things that we must strictly follow.”
Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.
While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.
The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).
“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.
While the WHO guidance does provide solid facts to support best practices for managing COVID-19, providers will also need to look beyond the document to tackle real-world issues, said David M. Ferraro, MD, FCCP, a pulmonary and critical care physician and associate professor of medicine at National Jewish Health in Denver.
For example, while the guidelines address the importance of screening and triage, limited COVID-19 testing may be a barrier to timely diagnoses that might compel more individuals to comply with social distancing recommendations, according to Dr. Ferraro, vice chair of the Fundamental Disaster Management Committee for the Society of Critical Care Medicine (SCCM).
“If we’re not providing people with confirmation that they have the virus, they may potentially continue to be spreaders of the disease, because they don’t have that absolute proof,” Dr. Ferraro said in an interview. “I think that’s where we are limited right now, because often we’re not able to tell the mild symptomatic people – or even the asymptomatic people – that they really need to play a role in preventing further spread.”
Likewise, the guidelines provide sound guidance on management of severe or critical COVID-19, according to Dr. Ferraro, yet they don’t address the potential for shortages of trained health care personnel to handle more severe cases requiring ventilation. That’s clearly an important issue, he said, especially with recent reports that the COVID-19 pandemic has pushed Italian intensive care units (ICUs) to the brink of collapse.
If the pandemic reaches crisis levels in the United States, nearly 1 million people would need ventilatory support, according to a recent report from SCCM on U.S. resource availability for COVID-19. And while there are an estimated 200,000 ventilators available in the United States, it’s estimated in that report that only 135,000 patients could be handled at a time, given the shortage of ICU physicians, advanced practice providers, nurses, and respiratory therapists with training in mechanical ventilation.
“If our ICUs get overwhelmed and swarmed, we may have the technology available, but we may not have enough resources and personnel to safely manage the number of patients,” Dr. Ferraro said.
The solution to that, according to the SCCM report, is to focus on expanding the pool of trained professionals who may be needed, not only to mechanically ventilate patients with COVID-19, but also to care for other critically ill patients routinely cared for in the ICU. They also suggest adopting a “tiered staffing strategy” in which non-ICU trained health care providers augment the capacity of experienced ICU staff.
With the prospect of untrained health care workers in mind, the WHO guidance could be a valuable resource for those who do have to jump into ICU roles, according to Dr. Ferraro.
The WHO also stresses immediate implementation of appropriate measures for infection prevention and control (IPC). According to their guidance, IPC needs to be initiated right at the point where the patient enters the hospital, with screening done at the first point of contact in the emergency department or outpatient clinics.
If patients are suspected to have COVID-19, they should receive a mask, and should be directed to a separate area where they are kept at least 1 meter apart from other individuals with suspected COVID-19, according to the WHO. (The Centers for Disease Control and Prevention recommends maintaining a distance of 6 feet to prevent spread of illness).
Beyond standard precautions such as hand washing and use of personal protective equipment, health care workers should do a point-of-care risk assessment at every patient contact to determine whether additional precautions are required.
Having standard IPC measures in place is “paramount,” according to Dr. Ferraro, for a disease that has no available vaccine, no proven treatments, and a stealthy spread fueled by asymptomatic carriers.
“Those are huge weapons against us, and the only thing we really have to knock this down is really infection prevention control, so that truly is at the cornerstone,” he said. “These are things that we must strictly follow.”
FROM THE WORLD HEALTH ORGANIZATION
Lopinavir-ritonavir trial results ‘disappointing’ for severe COVID-19
No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.
The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).
Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.
Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.
For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).
Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.
While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)
“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.
Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.
“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.
“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.
Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”
As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.
Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.
All authors had no financial conflicts of interest to disclose.
Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.
Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.
SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.
No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.
The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).
Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.
Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.
For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).
Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.
While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)
“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.
Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.
“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.
“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.
Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”
As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.
Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.
All authors had no financial conflicts of interest to disclose.
Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.
Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.
SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.
No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.
The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).
Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.
Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.
For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).
Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.
While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)
“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.
Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.
“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.
“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.
Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”
As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.
Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.
All authors had no financial conflicts of interest to disclose.
Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.
Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.
SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
AGA and colleague societies issue clinical insights for COVID-19
Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.
“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.
In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.
Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.
Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.
The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
Specific advice for the gastroenterology profession
The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.
Patient concerns
In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.
Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.
“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.
In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .
Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
Protection of practitioners
Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.
“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.
“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.
Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.
The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.
In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.
Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.
“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.
In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.
Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.
Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.
The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
Specific advice for the gastroenterology profession
The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.
Patient concerns
In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.
Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.
“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.
In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .
Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
Protection of practitioners
Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.
“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.
“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.
Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.
The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.
In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.
Amid the growing SARS-CoV-2 pandemic, currently in its expansive growth phase in the United States, the American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), the American College of Gastroenterology (ACG), and the American Society for Gastrointestinal Endoscopy (ASGE) have jointly released “COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers,” which can be found on the websites of the various societies.
“The purpose of this communication is to jointly provide you with up to date COVID-19 information in order to maintain the highest level of health and safety for our patients, staff, community, and ourselves,” according to the AGA website announcement.
In particular, the societies point out that there is recent evidence suggesting the potential for coronavirus transmission through droplets and perhaps fecal shedding, which pose potential risks in particular during endoscopy and colonoscopy procedures to other patients, endoscopy personnel, and practitioners.
Relevant clinical factors related to COVID-19 are discussed, including the fact that asymptomatic spread can occur during the prodromal phase (the mean incubation period is approximately 5 days, with a range of 0-14 days), with viral shedding greatest when symptoms begin.
Between 20% and 30% of patients with COVID-19 infection show abnormal liver enzymes. In addition, COVID-19 patients show drops in their leukocyte counts, and elevated white blood cell counts is a poor prognostic sign, according to the release.
The Centers for Disease Control and Prevention lists vulnerable populations at the greatest risk for more serious outcomes; these include the elderly and those with severe chronic health conditions, such as heart disease, lung disease, diabetes, decompensated cirrhosis, HIV with low CD4 counts, and immunosuppression (including liver and other solid organ transplant recipients), are at higher risk of developing more serious illness. In addition pregnancy may provide added risk.
Specific advice for the gastroenterology profession
The joint statement urges that practitioners strongly consider rescheduling elective nonurgent endoscopic procedures, although some nonurgent procedures are higher priority and may need to be performed, including cancer evaluations, prosthetic removals, and evaluation of significant symptoms. “Of note, the Surgeon General on 3/14/20 advised hospitals to postpone all elective surgeries,” the document states.
Patient concerns
In all cases, patients should be prescreened for high-risk exposure or symptoms. This includes asking about history of fever or respiratory symptoms, family members or close contacts with similar symptoms, any contact with a confirmed case of COVID-19, and recent travel to a high-risk area. “Avoid bringing patients (or their escorts) into the medical facility who are over age 65 or have one of the CDC recognized risks listed above,” the societies advise.
Check body temperature of the patient upon arrival at endoscopy unit or clinic, and keep all patients at an appropriate distance from each other (6 feet is recommended) throughout the entire time in the endoscopy unit.
“For COVID-19 positive patients, or those awaiting test results, isolation precautions should be taken with procedures performed in negative pressure rooms,” according to the statement.
In addition, use telemedicine where possible in elective cases, and consider phone follow-up after any procedures at 7 and 14 days to ask about new diagnosis of COVID-19 or development of its symptoms, .
Those patients who are on immunosuppressive drugs for inflammatory bowel disease and autoimmune hepatitis should continue taking their medications because the risk of disease flare outweighs the chance of contracting coronavirus, according to the document. In addition, these patients should be advised to follow CDC guidelines for at-risk groups by avoiding crowds and limiting travel.
Protection of practitioners
Key factors in ensuring practitioner safety and maintaining practice functionality are discussed by the joint document. In particular, appropriate personal protective equipment (PPE) should be worn by all members of the endoscopy team: gloves, mask, eye shield/goggles, face shields, and gown, but practitioners should also be aware of how to put on and take off PPE appropriately.
“Conservation of PPE is critical. Only essential personnel should be present in cases. Consider extended use or reuse of surgical masks and eye protection in accordance with hospital policies,” the document recommends.
“It is important to address our collective staff needs and institute policies that protect our workforce.” To that end, the document recommends that centers should strategically assign available personnel in order to minimize concomitant exposure of those with similar or unique skill sets. This includes the use of nonphysician practitioners and fellows that cannot participate in cases for screening and triaging patients, or performing virtual visits.
Coming at a time of pandemic, when gastrointestinal symptoms have been recognized as a more common symptom of COVID-19 than previously expected and liver damage has been noted as a potential repercussion of SARS-CoV-2 infection, these clinical insights provide a template for gastroenterologists and related professionals for dealing with their patients and keeping themselves safe under dramatically changed circumstances.
The partnered organizations, AASLD, ACG, AGA, and ASGE, are committed to providing updated COVID-19 information as appropriate. However: “Given the evolving and fluid nature of the situation, institutions, hospitals and clinics have also been formulating their own local guidelines, so we urge you to follow the evolving CDC recommendations and your local requirements,” according to the AGA website announcement.
In addition to the joint communication, the society websites each offer additional COVID-19 information. The AGA practice updates on the COVID-19 webpage provides information about announcements, such as the cancellation of Digestive Disease Week® in May, a location for AGA members to discuss their COVID-19 experiences and share advice, and links to the CDC COVID-19 updates.
SOURCE: American Gastroenterological Association et al. March 2020, COVID-19 Clinical Insights for Our Community of Gastroenterologists and Gastroenterology Care Providers.
Patients with COVID-19 may face risk for liver injury
Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.
Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.
“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”
The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.
In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.
Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.
According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.
“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.
Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).
“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.
Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.
SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.
Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.
Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.
“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”
The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.
In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.
Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.
According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.
“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.
Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).
“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.
Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.
SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.
Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.
Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.
“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”
The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.
In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.
Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.
According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.
“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.
Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).
“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.
Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.
SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.
FROM LIVER INTERNATIONAL
COVID-19 will test medical supply stocks
In a JAMA Live Stream interview, in the United States.
Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.
The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.
“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”
He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”
Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
Stress test on the health care system
Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.
In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”
The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.
Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
Returning to work after COVID-19 infection
Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.
“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.
Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
Higher risk reported in cardiac patients
Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.
Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.
He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
Potential therapies
Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.
Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”
In a JAMA Live Stream interview, in the United States.
Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.
The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.
“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”
He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”
Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
Stress test on the health care system
Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.
In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”
The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.
Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
Returning to work after COVID-19 infection
Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.
“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.
Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
Higher risk reported in cardiac patients
Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.
Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.
He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
Potential therapies
Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.
Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”
In a JAMA Live Stream interview, in the United States.
Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.
The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.
“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”
He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”
Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
Stress test on the health care system
Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.
In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”
The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.
Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
Returning to work after COVID-19 infection
Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.
“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.
Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
Higher risk reported in cardiac patients
Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.
Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.
He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
Potential therapies
Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.
Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”
REPORTING FROM JAMA LIVE STREAM
COVID-19 in China: Children have less severe disease, but are vulnerable
Clinical manifestations of COVID-19 infection among children in mainland China generally have been less severe than those among adults, but children of all ages – and infants in particular – are vulnerable to infection, according to a review of 2,143 cases.
Further, infection patterns in the nationwide series of all pediatric patients reported to the Chinese Center for Disease Control and Prevention from Jan. 16 to Feb. 8, 2020, provide strong evidence of human-to-human transmission, Yuanyuan Dong, MPH, a research assistant at Shanghai Children’s Medical Center, Shanghai Jiao Tong University, China, and colleagues reported in Pediatrics.
Of the 2,143 patients included in the review, 57% were boys and the median age was 7 years; 34% had laboratory-confirmed infection and 67% had suspected infection. More than 90% had asymptomatic, mild, or moderate disease (4%, 51%, and 39%, respectively), and 46% were from Hubei Province, where the first cases were reported, the investigators found.
The median time from illness onset to diagnosis was 2 days, and there was a trend of rapid increase of disease at the early stage of the epidemic – with rapid spread from Hubei Province to surrounding provinces – followed by a gradual and steady decrease, they noted.
“The total number of pediatric patients increased remarkably between mid-January and early February, peaked around February 1, and then declined since early February 2020,” they wrote. The proportion of severe and critical cases was 11% for infants under 1 year of age, compared with 7% for those aged 1-5 years; 4% for those aged 6-10 years; 4% for those 11-15 years; and 3% for those 16 years and older.
As of Feb. 8, 2020, only one child in this group of study patients died and most cases of COVID-19 symptoms were mild. There were many fewer severe and critical cases among the children (6%), compared with those reported in adult patients in other studies (19%). “It suggests that, compared with adult patients, clinical manifestations of children’s COVID-19 may be less severe,” the investigators suggested.
“As most of these children were likely to expose themselves to family members and/or other children with COVID-19, it clearly indicates person-to-person transmission ” of novel coronavirus 2019, they said, adding that similar evidence of such transmission also has been reported from studies of adult patients.
The reasons for reduced severity in children versus adults remain unclear, but may be related to both exposure and host factors, Ms. Dong and associates said. “Children were usually well cared for at home and might have relatively [fewer] opportunities to expose themselves to pathogens and/or sick patients.”
The findings demonstrate a pediatric distribution that varied across time and space, with most cases concentrated in the Hubei province and surrounding areas. No significant gender-related difference in infection rates was observed, and although the median patient age was 7 years, the range was 1 day to 18 years, suggesting that “all ages at childhood were susceptible” to the virus, they added.
The declining number of cases over time further suggests that disease control measures implemented by the government were effective, and that cases will “continue to decline, and finally stop in the near future unless sustained human-to-human transmissions occur,” Ms. Dong and associates concluded.
In an accompanying editorial, Andrea T. Cruz, MD, of Baylor College of Medicine, Houston, and Steven L. Zeichner, MD, PhD, of the University of Virginia, Charlottesville, said the findings regarding reduced severity among children versus adults with novel coronavirus 2019 infection are consistent with data on non-COVID-19 coronavirus.
They pointed out that Ms. Dong and associates did find that 13% of virologically-confirmed cases had asymptomatic infection, “a rate that almost certainly understates the true rate of asymptomatic infection, since many asymptomatic children are unlikely to be tested.”
Of the symptomatic children, “5% had dyspnea or hypoxemia (a substantially lower percentage than what has been reported for adults) and 0.6% progressed to acute respiratory distress syndrome (ARDS) or multiorgan system dysfunction”; this also is at a lower rate than seen in adults, they said.
Very young children –infants or children in preschool – were more likely to have severe clinical manifestations than children who were older.
Thus, it appears that certain subpopulations of children are at increased risk for more significant COVID-19 illness: “younger age, underlying pulmonary pathology, and immunocompromising conditions,” Dr. Cruz and Dr. Zeichner suggested.
The two editorialists said the findings suggest children “may play a major role in community-based viral transmission.” Evidence suggests that children may have more upper respiratory tract involvement and that fecal shedding may occur for several weeks after diagnosis; this raises concerns about fecal-oral transmission, particularly for infants and children, and about viral replication in the gastrointestinal tract, they said. This has substantial implications for community spread in day care centers, schools, and in the home.
A great deal has been learned about COVID-19 in a short time, but there still is much to learn about the effect of the virus on children, the impact of children on viral spread, and about possible vertical transmission, they said.
“Widespread availability of testing will allow for us to more accurately describe the spectrum of illness and may result in adjustment of the apparent morbidity and mortality rate as fewer ill individuals are diagnosed,” Dr. Cruz and Dr. Zeichner wrote, adding that “rigorously gauging the impact of COVID-19 on children will be important to accurately model the pandemic and to ensure that appropriate resources are allocated to children requiring care.”
They noted that understanding differences in children versus adults with COVID-19 “can yield important insights into disease pathogenesis, informing management and the development of therapeutics.”
This study was partially supported by the Science and Technology Commission of Shanghai Municipality. The authors reported having no disclosures. Dr. Cruz and Dr. Zeichner are associate editors for Pediatrics. Dr. Cruz reported having no disclosures. Dr. Zeichner is an inventor of new technologies for the rapid production of vaccines, for which the University of Virginia has filed patent applications.
SOURCE: Dong Y et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0702; Cruz A and Zeichner S. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0834.
Clinical manifestations of COVID-19 infection among children in mainland China generally have been less severe than those among adults, but children of all ages – and infants in particular – are vulnerable to infection, according to a review of 2,143 cases.
Further, infection patterns in the nationwide series of all pediatric patients reported to the Chinese Center for Disease Control and Prevention from Jan. 16 to Feb. 8, 2020, provide strong evidence of human-to-human transmission, Yuanyuan Dong, MPH, a research assistant at Shanghai Children’s Medical Center, Shanghai Jiao Tong University, China, and colleagues reported in Pediatrics.
Of the 2,143 patients included in the review, 57% were boys and the median age was 7 years; 34% had laboratory-confirmed infection and 67% had suspected infection. More than 90% had asymptomatic, mild, or moderate disease (4%, 51%, and 39%, respectively), and 46% were from Hubei Province, where the first cases were reported, the investigators found.
The median time from illness onset to diagnosis was 2 days, and there was a trend of rapid increase of disease at the early stage of the epidemic – with rapid spread from Hubei Province to surrounding provinces – followed by a gradual and steady decrease, they noted.
“The total number of pediatric patients increased remarkably between mid-January and early February, peaked around February 1, and then declined since early February 2020,” they wrote. The proportion of severe and critical cases was 11% for infants under 1 year of age, compared with 7% for those aged 1-5 years; 4% for those aged 6-10 years; 4% for those 11-15 years; and 3% for those 16 years and older.
As of Feb. 8, 2020, only one child in this group of study patients died and most cases of COVID-19 symptoms were mild. There were many fewer severe and critical cases among the children (6%), compared with those reported in adult patients in other studies (19%). “It suggests that, compared with adult patients, clinical manifestations of children’s COVID-19 may be less severe,” the investigators suggested.
“As most of these children were likely to expose themselves to family members and/or other children with COVID-19, it clearly indicates person-to-person transmission ” of novel coronavirus 2019, they said, adding that similar evidence of such transmission also has been reported from studies of adult patients.
The reasons for reduced severity in children versus adults remain unclear, but may be related to both exposure and host factors, Ms. Dong and associates said. “Children were usually well cared for at home and might have relatively [fewer] opportunities to expose themselves to pathogens and/or sick patients.”
The findings demonstrate a pediatric distribution that varied across time and space, with most cases concentrated in the Hubei province and surrounding areas. No significant gender-related difference in infection rates was observed, and although the median patient age was 7 years, the range was 1 day to 18 years, suggesting that “all ages at childhood were susceptible” to the virus, they added.
The declining number of cases over time further suggests that disease control measures implemented by the government were effective, and that cases will “continue to decline, and finally stop in the near future unless sustained human-to-human transmissions occur,” Ms. Dong and associates concluded.
In an accompanying editorial, Andrea T. Cruz, MD, of Baylor College of Medicine, Houston, and Steven L. Zeichner, MD, PhD, of the University of Virginia, Charlottesville, said the findings regarding reduced severity among children versus adults with novel coronavirus 2019 infection are consistent with data on non-COVID-19 coronavirus.
They pointed out that Ms. Dong and associates did find that 13% of virologically-confirmed cases had asymptomatic infection, “a rate that almost certainly understates the true rate of asymptomatic infection, since many asymptomatic children are unlikely to be tested.”
Of the symptomatic children, “5% had dyspnea or hypoxemia (a substantially lower percentage than what has been reported for adults) and 0.6% progressed to acute respiratory distress syndrome (ARDS) or multiorgan system dysfunction”; this also is at a lower rate than seen in adults, they said.
Very young children –infants or children in preschool – were more likely to have severe clinical manifestations than children who were older.
Thus, it appears that certain subpopulations of children are at increased risk for more significant COVID-19 illness: “younger age, underlying pulmonary pathology, and immunocompromising conditions,” Dr. Cruz and Dr. Zeichner suggested.
The two editorialists said the findings suggest children “may play a major role in community-based viral transmission.” Evidence suggests that children may have more upper respiratory tract involvement and that fecal shedding may occur for several weeks after diagnosis; this raises concerns about fecal-oral transmission, particularly for infants and children, and about viral replication in the gastrointestinal tract, they said. This has substantial implications for community spread in day care centers, schools, and in the home.
A great deal has been learned about COVID-19 in a short time, but there still is much to learn about the effect of the virus on children, the impact of children on viral spread, and about possible vertical transmission, they said.
“Widespread availability of testing will allow for us to more accurately describe the spectrum of illness and may result in adjustment of the apparent morbidity and mortality rate as fewer ill individuals are diagnosed,” Dr. Cruz and Dr. Zeichner wrote, adding that “rigorously gauging the impact of COVID-19 on children will be important to accurately model the pandemic and to ensure that appropriate resources are allocated to children requiring care.”
They noted that understanding differences in children versus adults with COVID-19 “can yield important insights into disease pathogenesis, informing management and the development of therapeutics.”
This study was partially supported by the Science and Technology Commission of Shanghai Municipality. The authors reported having no disclosures. Dr. Cruz and Dr. Zeichner are associate editors for Pediatrics. Dr. Cruz reported having no disclosures. Dr. Zeichner is an inventor of new technologies for the rapid production of vaccines, for which the University of Virginia has filed patent applications.
SOURCE: Dong Y et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0702; Cruz A and Zeichner S. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0834.
Clinical manifestations of COVID-19 infection among children in mainland China generally have been less severe than those among adults, but children of all ages – and infants in particular – are vulnerable to infection, according to a review of 2,143 cases.
Further, infection patterns in the nationwide series of all pediatric patients reported to the Chinese Center for Disease Control and Prevention from Jan. 16 to Feb. 8, 2020, provide strong evidence of human-to-human transmission, Yuanyuan Dong, MPH, a research assistant at Shanghai Children’s Medical Center, Shanghai Jiao Tong University, China, and colleagues reported in Pediatrics.
Of the 2,143 patients included in the review, 57% were boys and the median age was 7 years; 34% had laboratory-confirmed infection and 67% had suspected infection. More than 90% had asymptomatic, mild, or moderate disease (4%, 51%, and 39%, respectively), and 46% were from Hubei Province, where the first cases were reported, the investigators found.
The median time from illness onset to diagnosis was 2 days, and there was a trend of rapid increase of disease at the early stage of the epidemic – with rapid spread from Hubei Province to surrounding provinces – followed by a gradual and steady decrease, they noted.
“The total number of pediatric patients increased remarkably between mid-January and early February, peaked around February 1, and then declined since early February 2020,” they wrote. The proportion of severe and critical cases was 11% for infants under 1 year of age, compared with 7% for those aged 1-5 years; 4% for those aged 6-10 years; 4% for those 11-15 years; and 3% for those 16 years and older.
As of Feb. 8, 2020, only one child in this group of study patients died and most cases of COVID-19 symptoms were mild. There were many fewer severe and critical cases among the children (6%), compared with those reported in adult patients in other studies (19%). “It suggests that, compared with adult patients, clinical manifestations of children’s COVID-19 may be less severe,” the investigators suggested.
“As most of these children were likely to expose themselves to family members and/or other children with COVID-19, it clearly indicates person-to-person transmission ” of novel coronavirus 2019, they said, adding that similar evidence of such transmission also has been reported from studies of adult patients.
The reasons for reduced severity in children versus adults remain unclear, but may be related to both exposure and host factors, Ms. Dong and associates said. “Children were usually well cared for at home and might have relatively [fewer] opportunities to expose themselves to pathogens and/or sick patients.”
The findings demonstrate a pediatric distribution that varied across time and space, with most cases concentrated in the Hubei province and surrounding areas. No significant gender-related difference in infection rates was observed, and although the median patient age was 7 years, the range was 1 day to 18 years, suggesting that “all ages at childhood were susceptible” to the virus, they added.
The declining number of cases over time further suggests that disease control measures implemented by the government were effective, and that cases will “continue to decline, and finally stop in the near future unless sustained human-to-human transmissions occur,” Ms. Dong and associates concluded.
In an accompanying editorial, Andrea T. Cruz, MD, of Baylor College of Medicine, Houston, and Steven L. Zeichner, MD, PhD, of the University of Virginia, Charlottesville, said the findings regarding reduced severity among children versus adults with novel coronavirus 2019 infection are consistent with data on non-COVID-19 coronavirus.
They pointed out that Ms. Dong and associates did find that 13% of virologically-confirmed cases had asymptomatic infection, “a rate that almost certainly understates the true rate of asymptomatic infection, since many asymptomatic children are unlikely to be tested.”
Of the symptomatic children, “5% had dyspnea or hypoxemia (a substantially lower percentage than what has been reported for adults) and 0.6% progressed to acute respiratory distress syndrome (ARDS) or multiorgan system dysfunction”; this also is at a lower rate than seen in adults, they said.
Very young children –infants or children in preschool – were more likely to have severe clinical manifestations than children who were older.
Thus, it appears that certain subpopulations of children are at increased risk for more significant COVID-19 illness: “younger age, underlying pulmonary pathology, and immunocompromising conditions,” Dr. Cruz and Dr. Zeichner suggested.
The two editorialists said the findings suggest children “may play a major role in community-based viral transmission.” Evidence suggests that children may have more upper respiratory tract involvement and that fecal shedding may occur for several weeks after diagnosis; this raises concerns about fecal-oral transmission, particularly for infants and children, and about viral replication in the gastrointestinal tract, they said. This has substantial implications for community spread in day care centers, schools, and in the home.
A great deal has been learned about COVID-19 in a short time, but there still is much to learn about the effect of the virus on children, the impact of children on viral spread, and about possible vertical transmission, they said.
“Widespread availability of testing will allow for us to more accurately describe the spectrum of illness and may result in adjustment of the apparent morbidity and mortality rate as fewer ill individuals are diagnosed,” Dr. Cruz and Dr. Zeichner wrote, adding that “rigorously gauging the impact of COVID-19 on children will be important to accurately model the pandemic and to ensure that appropriate resources are allocated to children requiring care.”
They noted that understanding differences in children versus adults with COVID-19 “can yield important insights into disease pathogenesis, informing management and the development of therapeutics.”
This study was partially supported by the Science and Technology Commission of Shanghai Municipality. The authors reported having no disclosures. Dr. Cruz and Dr. Zeichner are associate editors for Pediatrics. Dr. Cruz reported having no disclosures. Dr. Zeichner is an inventor of new technologies for the rapid production of vaccines, for which the University of Virginia has filed patent applications.
SOURCE: Dong Y et al. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0702; Cruz A and Zeichner S. Pediatrics. 2020 Mar 16. doi: 10.1542/peds.2020-0834.
FROM PEDIATRICS
ACP outlines guide for COVID-19 telehealth coding, billing
and for handling clinician and staff absences due to illness or quarantine during the COVID-19 pandemic.
It strongly encourages practices to use telehealth, whenever possible, to mitigate exposure of patients who are sick or at risk because of other underlying conditions and to protect health care workers and the community from the spread of the disease.
The national organization of internists also recommends in the guidance that practices establish protocols and procedures for use by clinicians and all other staff in light of the pandemic.
The billing and coding tips are being offered to help practices deal with the rapidly changing situation surrounding the COVID-19 emergency, according to a statement from the ACP.
The coding-related guidance incorporates changes to a number of telehealth rules for Medicare beneficiaries, announced by the Centers for Medicare and Medicaid Services on March 17.
“Now in a full state of emergency, many Medicare restrictions related to telehealth have been lifted. Patients can be at home, and non-HIPAA compliant technology is allowed. There is no cost sharing for COVID-19 testing. In addition, to encourage use by patients, Medicare is allowing practices to waive cost sharing (copays and deductibles) for all telehealth services,” the organization said in the guidance. It notes, however, that the CMS does not currently reimburse for telephone calls.
The guidance includes details of the new ICD-10 codes, and stresses the importance of using the appropriate codes, given that some service cost-sharing has been waived for COVID-19 testing and treatment.
There is detailed coding guidance for virtual check-in, online evaluation and management, remote monitoring, originating site, and allowed technology and services.
In regard to clinician and staff absence due to illness or quarantine, the ACP says “practices may need to review emergency plans related to telework and to employee and clinician absence.” Among its recommendations are that practices and employers consider temporary adjustments to compensation formulas to accommodate those clinicians who experience a loss of income because they are paid based on production.
The organization emphasizes that, given the rapidly changing availability of testing for COVID-19, practices should contact their local health departments, hospitals, reference labs, or state health authorities to determine the status of their access to testing.
The full list of the ACP’s tips are available here.
Any new guidance for physicians will be posted on the ACP’s COVID-19 resource page.
and for handling clinician and staff absences due to illness or quarantine during the COVID-19 pandemic.
It strongly encourages practices to use telehealth, whenever possible, to mitigate exposure of patients who are sick or at risk because of other underlying conditions and to protect health care workers and the community from the spread of the disease.
The national organization of internists also recommends in the guidance that practices establish protocols and procedures for use by clinicians and all other staff in light of the pandemic.
The billing and coding tips are being offered to help practices deal with the rapidly changing situation surrounding the COVID-19 emergency, according to a statement from the ACP.
The coding-related guidance incorporates changes to a number of telehealth rules for Medicare beneficiaries, announced by the Centers for Medicare and Medicaid Services on March 17.
“Now in a full state of emergency, many Medicare restrictions related to telehealth have been lifted. Patients can be at home, and non-HIPAA compliant technology is allowed. There is no cost sharing for COVID-19 testing. In addition, to encourage use by patients, Medicare is allowing practices to waive cost sharing (copays and deductibles) for all telehealth services,” the organization said in the guidance. It notes, however, that the CMS does not currently reimburse for telephone calls.
The guidance includes details of the new ICD-10 codes, and stresses the importance of using the appropriate codes, given that some service cost-sharing has been waived for COVID-19 testing and treatment.
There is detailed coding guidance for virtual check-in, online evaluation and management, remote monitoring, originating site, and allowed technology and services.
In regard to clinician and staff absence due to illness or quarantine, the ACP says “practices may need to review emergency plans related to telework and to employee and clinician absence.” Among its recommendations are that practices and employers consider temporary adjustments to compensation formulas to accommodate those clinicians who experience a loss of income because they are paid based on production.
The organization emphasizes that, given the rapidly changing availability of testing for COVID-19, practices should contact their local health departments, hospitals, reference labs, or state health authorities to determine the status of their access to testing.
The full list of the ACP’s tips are available here.
Any new guidance for physicians will be posted on the ACP’s COVID-19 resource page.
and for handling clinician and staff absences due to illness or quarantine during the COVID-19 pandemic.
It strongly encourages practices to use telehealth, whenever possible, to mitigate exposure of patients who are sick or at risk because of other underlying conditions and to protect health care workers and the community from the spread of the disease.
The national organization of internists also recommends in the guidance that practices establish protocols and procedures for use by clinicians and all other staff in light of the pandemic.
The billing and coding tips are being offered to help practices deal with the rapidly changing situation surrounding the COVID-19 emergency, according to a statement from the ACP.
The coding-related guidance incorporates changes to a number of telehealth rules for Medicare beneficiaries, announced by the Centers for Medicare and Medicaid Services on March 17.
“Now in a full state of emergency, many Medicare restrictions related to telehealth have been lifted. Patients can be at home, and non-HIPAA compliant technology is allowed. There is no cost sharing for COVID-19 testing. In addition, to encourage use by patients, Medicare is allowing practices to waive cost sharing (copays and deductibles) for all telehealth services,” the organization said in the guidance. It notes, however, that the CMS does not currently reimburse for telephone calls.
The guidance includes details of the new ICD-10 codes, and stresses the importance of using the appropriate codes, given that some service cost-sharing has been waived for COVID-19 testing and treatment.
There is detailed coding guidance for virtual check-in, online evaluation and management, remote monitoring, originating site, and allowed technology and services.
In regard to clinician and staff absence due to illness or quarantine, the ACP says “practices may need to review emergency plans related to telework and to employee and clinician absence.” Among its recommendations are that practices and employers consider temporary adjustments to compensation formulas to accommodate those clinicians who experience a loss of income because they are paid based on production.
The organization emphasizes that, given the rapidly changing availability of testing for COVID-19, practices should contact their local health departments, hospitals, reference labs, or state health authorities to determine the status of their access to testing.
The full list of the ACP’s tips are available here.
Any new guidance for physicians will be posted on the ACP’s COVID-19 resource page.
Inactivated flu vaccine succeeds among autoimmune rheumatic disease patients
Use of the inactivated influenza vaccine by adults with autoimmune rheumatic diseases significantly reduced their risk of influenza-like illness, hospitalization for pneumonia and chronic obstructive pulmonary disease, and death from pneumonia, according to findings from an observational study of more than 30,000 patients in the U.K. Clinical Practice Research Datalink.
Although the inactivated vaccine has been recommended for patients with autoimmune rheumatic diseases (AIRDs), including rheumatoid arthritis and spondyloarthritis, the vaccine’s impact on patient outcomes including pneumonia, hospitalization, and death has not been well studied, wrote Georgina Nakafero, PhD, of the University of Nottingham, England, and colleagues.
In a study published in Rheumatology, the researchers identified 30,788 adults with AIRDs from the longitudinal Clinical Practice Research Datalink database in the United Kingdom. Of these, 66% were women, 76% had rheumatoid arthritis, and 61% had been prescribed methotrexate. The study included a total of 125,034 flu cycles between 2006 and 2009 and between 2010 and 2015.
Overall, vaccination with the inactivated influenza vaccine (IIV) reduced the risk of primary care consultation for influenza-like illness (adjusted odds ratio, 0.70), hospitalization for pneumonia (aOR, 0.61), exacerbation of chronic obstructive pulmonary disease (aOR, 0.67), and death caused by pneumonia (aOR, 0.48) in the study population. In a propensity score–adjusted analysis, only protection from influenza-like illness lost statistical significance.
In addition, vaccination was associated with a reduction in all-cause mortality among AIRDs patients, but restricting the outcomes to the active influenza periods may have confounded this result, the researchers said.
The study findings were limited by several factors including observational design, the use of a single vaccine efficacy estimate for each outcome, potential missed vaccination cycles, and potential confounding by indication and healthy user bias that could inflate the vaccine effectiveness, the researchers noted. However, the results were strengthened by the large sample size, including a range of AIRDs, and the use of both diagnostic and prescription codes, they said.
“The findings of this study, together with the results of our previous study demonstrating the safety of IIV in people with AIRDs, provides evidence to promote seasonal flu vaccination in this population,” they concluded. They still emphasized that randomized, controlled trials are needed for an assessment of vaccine efficacy.
The study was supported by Versus Arthritis and the National Institute of Health Research. Lead author Dr. Nakafero had no financial conflicts to disclose. Several coauthors disclosed relationships with companies, including AstraZeneca, Roche, and Pfizer.
SOURCE: Nakafero G et al. Rheumatology. 2020 Mar 11. doi: 10.1093/rheumatology/keaa078.
Use of the inactivated influenza vaccine by adults with autoimmune rheumatic diseases significantly reduced their risk of influenza-like illness, hospitalization for pneumonia and chronic obstructive pulmonary disease, and death from pneumonia, according to findings from an observational study of more than 30,000 patients in the U.K. Clinical Practice Research Datalink.
Although the inactivated vaccine has been recommended for patients with autoimmune rheumatic diseases (AIRDs), including rheumatoid arthritis and spondyloarthritis, the vaccine’s impact on patient outcomes including pneumonia, hospitalization, and death has not been well studied, wrote Georgina Nakafero, PhD, of the University of Nottingham, England, and colleagues.
In a study published in Rheumatology, the researchers identified 30,788 adults with AIRDs from the longitudinal Clinical Practice Research Datalink database in the United Kingdom. Of these, 66% were women, 76% had rheumatoid arthritis, and 61% had been prescribed methotrexate. The study included a total of 125,034 flu cycles between 2006 and 2009 and between 2010 and 2015.
Overall, vaccination with the inactivated influenza vaccine (IIV) reduced the risk of primary care consultation for influenza-like illness (adjusted odds ratio, 0.70), hospitalization for pneumonia (aOR, 0.61), exacerbation of chronic obstructive pulmonary disease (aOR, 0.67), and death caused by pneumonia (aOR, 0.48) in the study population. In a propensity score–adjusted analysis, only protection from influenza-like illness lost statistical significance.
In addition, vaccination was associated with a reduction in all-cause mortality among AIRDs patients, but restricting the outcomes to the active influenza periods may have confounded this result, the researchers said.
The study findings were limited by several factors including observational design, the use of a single vaccine efficacy estimate for each outcome, potential missed vaccination cycles, and potential confounding by indication and healthy user bias that could inflate the vaccine effectiveness, the researchers noted. However, the results were strengthened by the large sample size, including a range of AIRDs, and the use of both diagnostic and prescription codes, they said.
“The findings of this study, together with the results of our previous study demonstrating the safety of IIV in people with AIRDs, provides evidence to promote seasonal flu vaccination in this population,” they concluded. They still emphasized that randomized, controlled trials are needed for an assessment of vaccine efficacy.
The study was supported by Versus Arthritis and the National Institute of Health Research. Lead author Dr. Nakafero had no financial conflicts to disclose. Several coauthors disclosed relationships with companies, including AstraZeneca, Roche, and Pfizer.
SOURCE: Nakafero G et al. Rheumatology. 2020 Mar 11. doi: 10.1093/rheumatology/keaa078.
Use of the inactivated influenza vaccine by adults with autoimmune rheumatic diseases significantly reduced their risk of influenza-like illness, hospitalization for pneumonia and chronic obstructive pulmonary disease, and death from pneumonia, according to findings from an observational study of more than 30,000 patients in the U.K. Clinical Practice Research Datalink.
Although the inactivated vaccine has been recommended for patients with autoimmune rheumatic diseases (AIRDs), including rheumatoid arthritis and spondyloarthritis, the vaccine’s impact on patient outcomes including pneumonia, hospitalization, and death has not been well studied, wrote Georgina Nakafero, PhD, of the University of Nottingham, England, and colleagues.
In a study published in Rheumatology, the researchers identified 30,788 adults with AIRDs from the longitudinal Clinical Practice Research Datalink database in the United Kingdom. Of these, 66% were women, 76% had rheumatoid arthritis, and 61% had been prescribed methotrexate. The study included a total of 125,034 flu cycles between 2006 and 2009 and between 2010 and 2015.
Overall, vaccination with the inactivated influenza vaccine (IIV) reduced the risk of primary care consultation for influenza-like illness (adjusted odds ratio, 0.70), hospitalization for pneumonia (aOR, 0.61), exacerbation of chronic obstructive pulmonary disease (aOR, 0.67), and death caused by pneumonia (aOR, 0.48) in the study population. In a propensity score–adjusted analysis, only protection from influenza-like illness lost statistical significance.
In addition, vaccination was associated with a reduction in all-cause mortality among AIRDs patients, but restricting the outcomes to the active influenza periods may have confounded this result, the researchers said.
The study findings were limited by several factors including observational design, the use of a single vaccine efficacy estimate for each outcome, potential missed vaccination cycles, and potential confounding by indication and healthy user bias that could inflate the vaccine effectiveness, the researchers noted. However, the results were strengthened by the large sample size, including a range of AIRDs, and the use of both diagnostic and prescription codes, they said.
“The findings of this study, together with the results of our previous study demonstrating the safety of IIV in people with AIRDs, provides evidence to promote seasonal flu vaccination in this population,” they concluded. They still emphasized that randomized, controlled trials are needed for an assessment of vaccine efficacy.
The study was supported by Versus Arthritis and the National Institute of Health Research. Lead author Dr. Nakafero had no financial conflicts to disclose. Several coauthors disclosed relationships with companies, including AstraZeneca, Roche, and Pfizer.
SOURCE: Nakafero G et al. Rheumatology. 2020 Mar 11. doi: 10.1093/rheumatology/keaa078.
FROM RHEUMATOLOGY
Key clinical point: Adults with autoimmune rheumatic diseases who received the inactivated flu vaccine had lower rates of flu-like illness, hospitalization, and death than did those not vaccinated.
Major finding: Vaccination significantly reduced the risk of flu-like illness, hospitalization for pneumonia or COPD exacerbation, and death from pneumonia by 30%, 39%, 33%, and 52%, respectively.
Study details: The data come from 30,788 adults with AIRD and included 125,034 influenza cycles.
Disclosures: The study was supported by Versus Arthritis and the National Institute of Health Research. Lead author Dr. Nakafero had no financial conflicts to disclose. Several coauthors disclosed relationships with companies, including AstraZeneca, Roche, and Pfizer.
Source: Nakafero G et al. Rheumatology. 2020 Mar 11. doi: 10.1093/rheumatology/keaa078.
Clinicians petition government for national quarantine
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Clinicians across the United States are petitioning the federal government to follow the lead of South Korea, China, and other nations by imposing an immediate nationwide quarantine to slow the inevitable spread of COVID-19. Without federal action, the creators say, their lives and the lives of their colleagues, patients, and families are being put at increased risk.
In addition to the quarantine, the petition, posted on the website Change.org, calls on U.S. leaders to institute emergency production and distribution of personal protective equipment for healthcare workers and to rapidly increase access to testing.
The petition – which garnered more than 40,000 signatures in just 12 hours and as of this writing was approaching 94,000 – was started by an apolitical Facebook group to focus attention on what members see as the most critical issues for clinicians: slowing the spread of the virus through a coast-to-coast quarantine, protection of medical personnel with adequate supplies of essential equipment, and widespread testing.
“We started this group last Friday out of the realization that clinicians needed information about the outbreak and weren’t getting it,” said coadministrator Jessica McIntyre, MD, a pediatric hospitalist at Elliot Hospital in Manchester, N.H.
“We wanted to get ahead of it and connect with people before we were in the trenches experiencing it and to see what other programs were doing. From a local perspective, it has been really hard to see what people are doing in other states, especially when the protocols in our own states are changing every single day as we collect more information,” she said in an interview.
The Horse Has Bolted
A family medicine physician in Illinois helped launch the Facebook group. She asked that her name not be used but said in an interview that earlier actions may have prevented or at least delayed the need for the more draconian measures that her group is recommending.
“Clearly South Korea is one of the superstars as far as response has gone, but the concern we have in the United States is that we’re well beyond that point – we needed to be testing people over a month ago, in the hope of preventing a quarantine,” she said in an interview.
According to National Public Radio, as of March 13, South Korea had conducted 3,600 tests per million population, compared with five per million in the United States.
“I think the most concerning part is to see where Italy is now and where we are in comparison. Our ICUs have not yet overflowed, but I think we’re definitely looking at that in the next few weeks – hopefully longer, but I suspect that it will happen shortly,” she continued.
She cited work by Harvard University biostatistician Xihong Lin, PhD, that shows that when health authorities in Wuhan, China – widely cited as the epicenter of the global pandemic – cordoned off the city, the infection rate dropped from one person infecting 3.8 others to one infecting 1.25, thereby significantly slowing the rate of transmission.
“This is absolutely what we need to be doing,” she said.
Real News
Within 3 days of its creation, the online group had accrued more than 80,000 members with advanced medical training, including MDs, DOs, physician assistants, nurse practitioners, and certified registered nurse anesthetists.
“A lot of us were already very busy with our day-to-day work outside of COVID-19, and I think a lot of us felt unsure about where to get the best information,” said coadministrator David Janssen, MD, a family medicine physician in group practice in Sioux Center, Iowa,
“If you turn on the TV, there’s a lot of politicizing of the issue, and there’s a lot of good information, but also a lot of bad information. When health care providers talk to other health care providers, that’s often how we get our information and how we learn,” he said in an interview.
The COVID-19 U.S. Physicians/APP Facebook group includes 20 volunteer moderators who handle hundreds of posts per hour from persons seeking information on the novel coronavirus, what to tell patients, and how to protect themselves.
“It’s been wonderful to see how providers have been helping other providers sort through issues. Teaching hospitals have their hands on the latest research, but a lot of people like myself are at small community hospitals, critical-access hospitals, where we may have a lot of questions but don’t necessarily have the answers readily available to us,” Dr. Janssen said.
Dr. Janssen said that his community of about 8,000 residents initially had only four COVID-19 testing kits, or one for every 2,000 people. The situation has since improved, and more tests are now available, he added.
Dr. McIntyre, Dr. Janssen, and the Illinois family physician have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.