CHEST Physician

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

The Trump Administration is looking to telehealth services to play a more prominent role in helping mitigate the spread of COVID-19 by expanding existing benefits for Medicare beneficiaries.

“Medicare can pay for office, hospital, and other visits furnished via telehealth across the country and including in patients’ places of residence, starting March 6, 2020,” the Centers for Medicare & Medicaid Services said in a fact sheet issued March 17.

Some of the existing benefits were previously limited to rural communities.

“Medicare beneficiaries across the nation, no matter where they live, will now be able to receive a wide range of services via telehealth without ever having to leave home,” CMS Administrator Seema Verma said during a March 17 White House press briefing on administration actions to contain the spread of COVID-19. “These services can also be provided in a variety of settings, including nursing homes, hospital outpatient departments, and more.”

That means that seniors can continue to receive their routine care without having to leave the home and risk infection, or they can get medical guidance if they have mild symptoms, which would help mitigate the spread to others.

“This shift is very important for clinicians and providers who, over the coming weeks, will face considerable strain on their time and resources,” Dr. Verma said. “[It] allows the health care system to prioritize care for those who have more needs or who are in dire need, and it also preserves protective equipment.”

A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office.

This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.

“In addition, the [Health and Human Services’] office of inspector general is providing flexibility for health care providers to reduce or waive cost-sharing for telehealth visits paid by federal health care programs,” the fact sheet states. CMS also said it will not conduct audits to ensure that an established relationship exists between the provider and the patient – a prior requirement for telehealth billing – during this public health emergency.

Billing for virtual check-ins, which are essentially brief conversations that may not require a full visit to the physician office, needs an established relationship between the practice and the patient. Likewise, for e-visits, which include non–face-to-face communications through online patient portals, billing can occur only when there is an established patient relationship.

Key to the expansion is that it will cover the entire United States and will not be limited to rural areas.

Dr. Verma also noted that the administration “will be temporarily suspending certain HIPAA requirements so that doctors can provide telehealth with their own phones.”

She noted this was all a part of mitigation efforts to limit the spread of COVID-19.

“As we are encouraging Americans to stay home whenever possible, we don’t want our Medicare policies getting in the way,” she said, adding that state Medicaid agencies can expand their telehealth services without the approval of CMS during this emergency.

[email protected]

The novel coronavirus, SARS-CoV-2, remains viable in aerosols for hours and on surfaces for days, according to a new study.

The data indicate that the stability of the new virus is similar to that of SARS-CoV-1, which caused the SARS epidemic, researchers report in an article published on the medRxivpreprint server. (The posted article has been submitted for journal publication but has not been peer reviewed.)

Transmission of SARS-CoV-2, which causes COVID-19, has quickly outstripped the pace of the 2003 SARS epidemic. “Superspread” of the earlier disease arose from infection during medical procedures, in which a single infected individual seeded many secondary cases. In contrast, the novel coronavirus appears to be spread more through human-to-human transmission in a variety of settings.

However, it’s not yet known the extent to which asymptomatic or presymptomatic individuals spread the new virus through daily routine.

To investigate how long SARS-CoV-2 remains infective in the environment, Neeltje van Doremalen, PhD, of the Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, in Hamilton, Montana, and colleagues conducted simulation experiments in which they compared the viability of SARS-CoV-2 with that of SARS-CoV-1 in aerosols and on surfaces.

Among patients infected with SARS-CoV-2, viral loads in the upper respiratory tract are high; as a consequence, respiratory secretion in the form of aerosols (<5 μm) or droplets (>5 mcm) is likely, the authors note.

van Doremalen and colleagues used nebulizers to generate aerosols. Samples of SARS-CoV-1 and SARS-CoV-2 were collecting at 0, 30, 60, 120, and 180 minutes on a gelatin filter. The researchers then tested the infectivity of the viruses on Vero cells grown in culture.

They found that SARS-CoV-2 was largely stable through the full 180-minute test, with only a slight decline at 3 hours. This time course is similar to that of SARS-CoV-1; both viruses have a median half-life in aerosols of 2.7 hours (range, 1.65 hr for SARS-CoV-1, vs 7.24 hr for SARS-CoV-2).

The researchers then tested the viruses on a variety of surfaces for up to 7 days, using humidity values and temperatures designed to mimic “a variety of household and hospital situations.” The volumes of viral exposures that the team used were consistent with amounts found in the human upper and lower respiratory tracts.

For example, they applied 50 mcL of virus-containing solution to a piece of cardboard and then swabbed the surface, at different times, with an additional 1 mcL of medium. Each surface assay was replicated three times.

The novel coronavirus was most stable on plastic and stainless steel, with some virus remaining viable up to 72 hours. However, by that time the viral load had fallen by about three orders of magnitude, indicating exponential decay. This profile was remarkably similar to that of SARS-CoV-1, according to the authors.

However, the two viruses differed in staying power on copper and cardboard. No viable SARS-CoV-2 was detectable on copper after 4 hours or on cardboard after 24 hours. In contrast, SARS-CoV-1 was not viable beyond 8 hours for either copper or cardboard.

“Taken together, our results indicate that aerosol and fomite transmission of HCoV-19 [SARS-CoV-2] are plausible, as the virus can remain viable in aerosols for multiple hours and on surfaces up to days,” the authors conclude.

Andrew Pekosz, PhD, codirector of the Center of Excellence in Influenza Research and Surveillance and director of the Center for Emerging Viruses and Infectious Diseases at the Johns Hopkins Center for Global Health, Baltimore, Maryland, applauds the real-world value of the experiments.

“The PCR [polymerase chain reaction] test used [in other studies] to detect SARS-CoV-2 just detects the virus genome. It doesn’t tell you if the virus was still infectious, or ‘viable.’ That’s why this study is interesting,” Pekosz said. “It focuses on infectious virus, which is the virus that has the potential to transmit and infect another person. What we don’t know yet is how much infectious (viable) virus is needed to initiate infection in another person.”

He suggests that further investigations evaluate other types of environmental surfaces, including lacquered wood that is made into desks and ceramic tiles found in bathrooms and kitchens.

One limitation of the study is that the data for experiments on cardboard were more variable than the data for other surfaces tested.

The investigators and Pekosz have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The novel coronavirus, SARS-CoV-2, remains viable in aerosols for hours and on surfaces for days, according to a new study.

The data indicate that the stability of the new virus is similar to that of SARS-CoV-1, which caused the SARS epidemic, researchers report in an article published on the medRxivpreprint server. (The posted article has been submitted for journal publication but has not been peer reviewed.)

Transmission of SARS-CoV-2, which causes COVID-19, has quickly outstripped the pace of the 2003 SARS epidemic. “Superspread” of the earlier disease arose from infection during medical procedures, in which a single infected individual seeded many secondary cases. In contrast, the novel coronavirus appears to be spread more through human-to-human transmission in a variety of settings.

However, it’s not yet known the extent to which asymptomatic or presymptomatic individuals spread the new virus through daily routine.

To investigate how long SARS-CoV-2 remains infective in the environment, Neeltje van Doremalen, PhD, of the Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, in Hamilton, Montana, and colleagues conducted simulation experiments in which they compared the viability of SARS-CoV-2 with that of SARS-CoV-1 in aerosols and on surfaces.

Among patients infected with SARS-CoV-2, viral loads in the upper respiratory tract are high; as a consequence, respiratory secretion in the form of aerosols (<5 μm) or droplets (>5 mcm) is likely, the authors note.

van Doremalen and colleagues used nebulizers to generate aerosols. Samples of SARS-CoV-1 and SARS-CoV-2 were collecting at 0, 30, 60, 120, and 180 minutes on a gelatin filter. The researchers then tested the infectivity of the viruses on Vero cells grown in culture.

They found that SARS-CoV-2 was largely stable through the full 180-minute test, with only a slight decline at 3 hours. This time course is similar to that of SARS-CoV-1; both viruses have a median half-life in aerosols of 2.7 hours (range, 1.65 hr for SARS-CoV-1, vs 7.24 hr for SARS-CoV-2).

The researchers then tested the viruses on a variety of surfaces for up to 7 days, using humidity values and temperatures designed to mimic “a variety of household and hospital situations.” The volumes of viral exposures that the team used were consistent with amounts found in the human upper and lower respiratory tracts.

For example, they applied 50 mcL of virus-containing solution to a piece of cardboard and then swabbed the surface, at different times, with an additional 1 mcL of medium. Each surface assay was replicated three times.

The novel coronavirus was most stable on plastic and stainless steel, with some virus remaining viable up to 72 hours. However, by that time the viral load had fallen by about three orders of magnitude, indicating exponential decay. This profile was remarkably similar to that of SARS-CoV-1, according to the authors.

However, the two viruses differed in staying power on copper and cardboard. No viable SARS-CoV-2 was detectable on copper after 4 hours or on cardboard after 24 hours. In contrast, SARS-CoV-1 was not viable beyond 8 hours for either copper or cardboard.

“Taken together, our results indicate that aerosol and fomite transmission of HCoV-19 [SARS-CoV-2] are plausible, as the virus can remain viable in aerosols for multiple hours and on surfaces up to days,” the authors conclude.

Andrew Pekosz, PhD, codirector of the Center of Excellence in Influenza Research and Surveillance and director of the Center for Emerging Viruses and Infectious Diseases at the Johns Hopkins Center for Global Health, Baltimore, Maryland, applauds the real-world value of the experiments.

“The PCR [polymerase chain reaction] test used [in other studies] to detect SARS-CoV-2 just detects the virus genome. It doesn’t tell you if the virus was still infectious, or ‘viable.’ That’s why this study is interesting,” Pekosz said. “It focuses on infectious virus, which is the virus that has the potential to transmit and infect another person. What we don’t know yet is how much infectious (viable) virus is needed to initiate infection in another person.”

He suggests that further investigations evaluate other types of environmental surfaces, including lacquered wood that is made into desks and ceramic tiles found in bathrooms and kitchens.

One limitation of the study is that the data for experiments on cardboard were more variable than the data for other surfaces tested.

The investigators and Pekosz have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The novel coronavirus, SARS-CoV-2, remains viable in aerosols for hours and on surfaces for days, according to a new study.

The data indicate that the stability of the new virus is similar to that of SARS-CoV-1, which caused the SARS epidemic, researchers report in an article published on the medRxivpreprint server. (The posted article has been submitted for journal publication but has not been peer reviewed.)

Transmission of SARS-CoV-2, which causes COVID-19, has quickly outstripped the pace of the 2003 SARS epidemic. “Superspread” of the earlier disease arose from infection during medical procedures, in which a single infected individual seeded many secondary cases. In contrast, the novel coronavirus appears to be spread more through human-to-human transmission in a variety of settings.

However, it’s not yet known the extent to which asymptomatic or presymptomatic individuals spread the new virus through daily routine.

To investigate how long SARS-CoV-2 remains infective in the environment, Neeltje van Doremalen, PhD, of the Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, in Hamilton, Montana, and colleagues conducted simulation experiments in which they compared the viability of SARS-CoV-2 with that of SARS-CoV-1 in aerosols and on surfaces.

Among patients infected with SARS-CoV-2, viral loads in the upper respiratory tract are high; as a consequence, respiratory secretion in the form of aerosols (<5 μm) or droplets (>5 mcm) is likely, the authors note.

van Doremalen and colleagues used nebulizers to generate aerosols. Samples of SARS-CoV-1 and SARS-CoV-2 were collecting at 0, 30, 60, 120, and 180 minutes on a gelatin filter. The researchers then tested the infectivity of the viruses on Vero cells grown in culture.

They found that SARS-CoV-2 was largely stable through the full 180-minute test, with only a slight decline at 3 hours. This time course is similar to that of SARS-CoV-1; both viruses have a median half-life in aerosols of 2.7 hours (range, 1.65 hr for SARS-CoV-1, vs 7.24 hr for SARS-CoV-2).

The researchers then tested the viruses on a variety of surfaces for up to 7 days, using humidity values and temperatures designed to mimic “a variety of household and hospital situations.” The volumes of viral exposures that the team used were consistent with amounts found in the human upper and lower respiratory tracts.

For example, they applied 50 mcL of virus-containing solution to a piece of cardboard and then swabbed the surface, at different times, with an additional 1 mcL of medium. Each surface assay was replicated three times.

The novel coronavirus was most stable on plastic and stainless steel, with some virus remaining viable up to 72 hours. However, by that time the viral load had fallen by about three orders of magnitude, indicating exponential decay. This profile was remarkably similar to that of SARS-CoV-1, according to the authors.

However, the two viruses differed in staying power on copper and cardboard. No viable SARS-CoV-2 was detectable on copper after 4 hours or on cardboard after 24 hours. In contrast, SARS-CoV-1 was not viable beyond 8 hours for either copper or cardboard.

“Taken together, our results indicate that aerosol and fomite transmission of HCoV-19 [SARS-CoV-2] are plausible, as the virus can remain viable in aerosols for multiple hours and on surfaces up to days,” the authors conclude.

Andrew Pekosz, PhD, codirector of the Center of Excellence in Influenza Research and Surveillance and director of the Center for Emerging Viruses and Infectious Diseases at the Johns Hopkins Center for Global Health, Baltimore, Maryland, applauds the real-world value of the experiments.

“The PCR [polymerase chain reaction] test used [in other studies] to detect SARS-CoV-2 just detects the virus genome. It doesn’t tell you if the virus was still infectious, or ‘viable.’ That’s why this study is interesting,” Pekosz said. “It focuses on infectious virus, which is the virus that has the potential to transmit and infect another person. What we don’t know yet is how much infectious (viable) virus is needed to initiate infection in another person.”

He suggests that further investigations evaluate other types of environmental surfaces, including lacquered wood that is made into desks and ceramic tiles found in bathrooms and kitchens.

One limitation of the study is that the data for experiments on cardboard were more variable than the data for other surfaces tested.

The investigators and Pekosz have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The novel coronavirus (2019-nCoV) shows evidence of causing gastrointestinal symptoms and has the potential to be transmitted by the fecal-oral route, according to a new report from physicians at Shanghai Jiao Tong University, published online (Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054).

The virus’s respiratory symptoms are well documented and suggest primary transmission by droplet or contact, while other symptoms such as diarrhea, nausea, vomiting, and abdominal discomfort are less common and appear to vary between populations. The SARS coronavirus showed up in stool, even sometimes in patients discharged from the hospital. In a study of hospitalized patients in Wuhan, China, 10.1% of coronavirus patients had diarrhea and nausea in the 1-2 days before onset of fever and dyspnea. The first U.S. patient to be diagnosed had a 2-day history of nausea and vomiting, and had a loose bowel movement on the second day in the hospital. Clinicians later confirmed the presence of viral RNA in both the patient’s stool and airway.

The authors say that researchers in China have isolated viral RNA from the stool of two patients (unpublished), and it has been found in saliva, suggesting the possibility of the salivary gland as an infection or transmission route.

The authors maintain that previous studies likely overlooked or neglected patients who had mild intestinal symptoms. “Many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” the authors wrote.

Like other coronaviruses, it appears that 2019-nCoV infects cells through an interaction between viral transmembrane spike glycoprotein (S-protein) receptor-binding domain, and the cell receptors angiotensin-converting enzyme 2 (ACE-2) and host cellular transmembrane serine protease (TMPRSS). Transcriptome analysis has shown that human lung AT2 cells express ACE-2 and TMPRSS, but esophagus upper and stratified epithelial cells also express both factors, as do stratified epithelial cells and absorptive enterocytes in the ileum and colon.

The researchers call for investigation into ACE-2 fusion proteins and TMPRSS inhibitors for diagnosis, prophylaxis, or treatment of COVID-19.

The authors also noted that COVID-19 has been linked to mild to moderate liver injury as revealed by elevated aminotransferases, hypoproteinemia and prothrombin time prolongation. This also has precedent in that the SARS coronavirus can infect the liver, and biopsies revealed mitoses and apoptosis, along with other abnormalities. SARS-associated hepatitis may be the result of viral hepatitis, immune overreaction, or a secondary effect of antiviral medications or other drugs. Little is known to date about the ability of 2019-nCoV to infect the liver, but single-cell RNA sequencing data from two distinct cohorts showed more ACE-2 expression in cholangiocytes (59.7%) than hepatocytes (2.6%), which indicates that the virus might directly affect intrahepatic bile ducts.

The authors had no sources of funding or financial conflicts.

SOURCE: GU J et al. Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054.

*This story was updated on 4/10.2020.

The novel coronavirus (2019-nCoV) shows evidence of causing gastrointestinal symptoms and has the potential to be transmitted by the fecal-oral route, according to a new report from physicians at Shanghai Jiao Tong University, published online (Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054).

The virus’s respiratory symptoms are well documented and suggest primary transmission by droplet or contact, while other symptoms such as diarrhea, nausea, vomiting, and abdominal discomfort are less common and appear to vary between populations. The SARS coronavirus showed up in stool, even sometimes in patients discharged from the hospital. In a study of hospitalized patients in Wuhan, China, 10.1% of coronavirus patients had diarrhea and nausea in the 1-2 days before onset of fever and dyspnea. The first U.S. patient to be diagnosed had a 2-day history of nausea and vomiting, and had a loose bowel movement on the second day in the hospital. Clinicians later confirmed the presence of viral RNA in both the patient’s stool and airway.

The authors say that researchers in China have isolated viral RNA from the stool of two patients (unpublished), and it has been found in saliva, suggesting the possibility of the salivary gland as an infection or transmission route.

The authors maintain that previous studies likely overlooked or neglected patients who had mild intestinal symptoms. “Many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” the authors wrote.

Like other coronaviruses, it appears that 2019-nCoV infects cells through an interaction between viral transmembrane spike glycoprotein (S-protein) receptor-binding domain, and the cell receptors angiotensin-converting enzyme 2 (ACE-2) and host cellular transmembrane serine protease (TMPRSS). Transcriptome analysis has shown that human lung AT2 cells express ACE-2 and TMPRSS, but esophagus upper and stratified epithelial cells also express both factors, as do stratified epithelial cells and absorptive enterocytes in the ileum and colon.

The researchers call for investigation into ACE-2 fusion proteins and TMPRSS inhibitors for diagnosis, prophylaxis, or treatment of COVID-19.

The authors also noted that COVID-19 has been linked to mild to moderate liver injury as revealed by elevated aminotransferases, hypoproteinemia and prothrombin time prolongation. This also has precedent in that the SARS coronavirus can infect the liver, and biopsies revealed mitoses and apoptosis, along with other abnormalities. SARS-associated hepatitis may be the result of viral hepatitis, immune overreaction, or a secondary effect of antiviral medications or other drugs. Little is known to date about the ability of 2019-nCoV to infect the liver, but single-cell RNA sequencing data from two distinct cohorts showed more ACE-2 expression in cholangiocytes (59.7%) than hepatocytes (2.6%), which indicates that the virus might directly affect intrahepatic bile ducts.

The authors had no sources of funding or financial conflicts.

SOURCE: GU J et al. Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054.

*This story was updated on 4/10.2020.

The novel coronavirus (2019-nCoV) shows evidence of causing gastrointestinal symptoms and has the potential to be transmitted by the fecal-oral route, according to a new report from physicians at Shanghai Jiao Tong University, published online (Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054).

The virus’s respiratory symptoms are well documented and suggest primary transmission by droplet or contact, while other symptoms such as diarrhea, nausea, vomiting, and abdominal discomfort are less common and appear to vary between populations. The SARS coronavirus showed up in stool, even sometimes in patients discharged from the hospital. In a study of hospitalized patients in Wuhan, China, 10.1% of coronavirus patients had diarrhea and nausea in the 1-2 days before onset of fever and dyspnea. The first U.S. patient to be diagnosed had a 2-day history of nausea and vomiting, and had a loose bowel movement on the second day in the hospital. Clinicians later confirmed the presence of viral RNA in both the patient’s stool and airway.

The authors say that researchers in China have isolated viral RNA from the stool of two patients (unpublished), and it has been found in saliva, suggesting the possibility of the salivary gland as an infection or transmission route.

The authors maintain that previous studies likely overlooked or neglected patients who had mild intestinal symptoms. “Many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” the authors wrote.

Like other coronaviruses, it appears that 2019-nCoV infects cells through an interaction between viral transmembrane spike glycoprotein (S-protein) receptor-binding domain, and the cell receptors angiotensin-converting enzyme 2 (ACE-2) and host cellular transmembrane serine protease (TMPRSS). Transcriptome analysis has shown that human lung AT2 cells express ACE-2 and TMPRSS, but esophagus upper and stratified epithelial cells also express both factors, as do stratified epithelial cells and absorptive enterocytes in the ileum and colon.

The researchers call for investigation into ACE-2 fusion proteins and TMPRSS inhibitors for diagnosis, prophylaxis, or treatment of COVID-19.

The authors also noted that COVID-19 has been linked to mild to moderate liver injury as revealed by elevated aminotransferases, hypoproteinemia and prothrombin time prolongation. This also has precedent in that the SARS coronavirus can infect the liver, and biopsies revealed mitoses and apoptosis, along with other abnormalities. SARS-associated hepatitis may be the result of viral hepatitis, immune overreaction, or a secondary effect of antiviral medications or other drugs. Little is known to date about the ability of 2019-nCoV to infect the liver, but single-cell RNA sequencing data from two distinct cohorts showed more ACE-2 expression in cholangiocytes (59.7%) than hepatocytes (2.6%), which indicates that the virus might directly affect intrahepatic bile ducts.

The authors had no sources of funding or financial conflicts.

SOURCE: GU J et al. Gastroenterology. 2020 March 3. doi: 10.1053/j.gastro.2020.02.054.

*This story was updated on 4/10.2020.

Patients with diabetes may be at extra risk for coronavirus disease (COVID-19) mortality, and doctors treating them need to keep up with the latest guidelines and expert advice.

Most health advisories about COVID-19 mention diabetes as one of the high-risk categories for the disease, likely because early data coming out of China, where the disease was first reported, indicated an elevated case-fatality rate for COVID-19 patients who also had diabetes.

In an article published in JAMA, Zunyou Wu, MD, and Jennifer M. McGoogan, PhD, summarized the findings from a February report on 44,672 confirmed cases of the disease from the Chinese Center for Disease Control and Prevention. The overall case-fatality rate (CFR) at that stage was 2.3% (1,023 deaths of the 44,672 confirmed cases). The data indicated that the CFR was elevated among COVID-19 patients with preexisting comorbid conditions, specifically, cardiovascular disease (CFR, 10.5%), diabetes (7.3%), chronic respiratory disease (6.3%), hypertension (6%), and cancer (5.6%).

The data also showed an aged-related trend in the CFR, with patients aged 80 years or older having a CFR of 14.8% and those aged 70-79 years, a rate of 8.0%, while there were no fatal cases reported in patients aged 9 years or younger (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

Those findings have been echoed by the U.S. Centers of Disease Control and Prevention. The American Diabetes Association and the American Association of Clinical Endocrinologists have in turn referenced the CDC in their COVID-19 guidance recommendations for patients with diabetes.

Guidelines were already in place for treatment of infections in patients with diabetes, and at this stage, it seems that the same guidelines would extend to those patients who are also diagnosed with COVID-19, which is caused by the novel coronavirus, SARS-CoV-2.

In general, patients with diabetes – especially those whose disease is not controlled, or not well controlled – can be more susceptible to more common infections, such as influenza and pneumonia, possibly because hyperglycemia can subdue immunity by disrupting function of the white blood cells.
 

Glucose control is key

An important factor in any form of infection control in patients with diabetes seems to be whether or not a patient’s glucose levels are well controlled, according to comments from members of the editorial advisory board for Clinical Endocrinology News. Good glucose control, therefore, could be instrumental in reducing both the risk for and severity of infection.

Paul Jellinger, MD, of the Center for Diabetes & Endocrine Care, Hollywood, Fla., said that, over the years, he had not observed higher infection rates in general in patients with hemoglobin A_1c levels below 7, or even higher. However, “a bigger question for me, given the broad category of ‘diabetes’ listed as a risk for serious coronavirus complications by the CDC, has been: Just which individuals with diabetes are really at risk? Are patients with well-controlled diabetes at increased risk as much as those with significant hyperglycemia and uncontrolled diabetes? In my view, not likely.”

Alan Jay Cohen, MD, agreed with Dr. Jellinger. “Many patients have called the office in the last 10 days to ask if there are special precautions they should take because they are reading that they are in the high-risk group because they have diabetes. Many of them are in superb, or at least pretty good, control. I have not seen where they have had a higher incidence of infection than the general population, and I have not seen data with COVID-19 that specifically demonstrates that a person with diabetes in good control has an increased risk,” he said.

“My recommendations to these patients have been the same as those given to the general population,” added Dr. Cohen, medical director at Baptist Medical Group: The Endocrine Clinic, Memphis.

Herbert I. Rettinger, MD, also conceded that poorly controlled blood sugars and confounding illnesses, such as renal and cardiac conditions, are common in patients with long-standing diabetes, but “there is a huge population of patients with type 1 diabetes, and very few seem to be more susceptible to infection. Perhaps I am missing those with poor diet and glucose control.”

Philip Levy, MD, picked up on that latter point, emphasizing that “endocrinologists take care of fewer patients with diabetes than do primary care physicians. Most patients with type 2 diabetes are not seen by us unless the PCP has problems [treating them],” so it could be that PCPs may see a higher number of patients who are at a greater risk for infections.

Ultimately, “good glucose control is very helpful in avoiding infections,” said Dr. Levy, of the Banner University Medical Group Endocrinology & Diabetes, Phoenix.
 

For sick patients

Guidelines for patients at the Joslin Diabetes Center in Boston advise patients who are feeling sick to continue taking their diabetes medications, unless instructed otherwise by their providers, and to monitor their glucose more frequently because it can spike suddenly.

Patients with type 1 diabetes should check for ketones if their glucose passes 250 mg/dL, according to the guidelines, and patients should remain hydrated at all times and get plenty of rest.

“Sick-day guidelines definitely apply, but patients should be advised to get tested if they have any symptoms they are concerned about,” said Dr. Rettinger, of the Endocrinology Medical Group of Orange County, Orange, Calif.

If patients with diabetes develop COVID-19, then home management may still be possible, according to Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues (Diabetes Metab Syndr. 2020 Mar 10;14[3]:211-2. doi: 10.1016/j.dsx.2020.03.002).

Dr. Rettinger agreed, noting that home management would be feasible as long as “everything is going well, that is, the patient is not experiencing respiratory problems or difficulties in controlling glucose levels. Consider patients with type 1 diabetes who have COVID-19 as you would a nursing home patient – ever vigilant.”

Dr. Gupta and coauthors also recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve. However, the ADA warns in its guidelines that patients should “be aware that some constant glucose monitoring sensors (Dexcom G5, Medtronic Enlite, and Guardian) are impacted by acetaminophen (Tylenol), and that patients should check with finger sticks to ensure accuracy [if they are taking acetaminophen].”

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often, the authors wrote, cautioning that “frequent changes in dosage and correctional bolus may be required to maintain normoglycemia.” Dr Rettinger emphasized that “hyperglycemia, as always, is best treated with fluids and insulin and frequent checks of sugars to be sure the treatment regimen is successful.”

In regard to diabetic drug regimens, patients with type 1 or 2 disease should continue on their current medications, advised Yehuda Handelsman, MD. “Some, especially those on insulin, may require more of it. And the patient should increase fluid intake to prevent fluid depletion. We do not reduce antihyperglycemic medication to preserve fluids.

Preventive measures

In the interest of maintaining good glucose control, patients also should monitor their glucose levels more frequently so that fluctuations can be detected early and quickly addressed with the appropriate medication adjustments, according to guidelines from the ADA and AACE. They should continue to follow a healthy diet that includes adequate protein and they should exercise regularly.

Patients should ensure that they have enough medication and testing supplies – for at least 14 days, and longer, if costs permit – in case they have to go into quarantine.

General preventive measures, such as frequent hand washing with soap and water, practicing good respiratory hygiene by sneezing or coughing into a facial tissue or bent elbow, also apply for reducing the risk of infection. Touching of the face should be avoided, as should nonessential travel and contact with infected individuals.

Patients with diabetes should always be current with their influenza and pneumonia shots.

Dr. Rettinger said that he always recommends the following preventative measures to his patients and he is using the current health crisis to reinforce them:

• Eat lots of multicolored fruits and vegetables.
• Eat yogurt and take probiotics to keep the intestinal biome strong and functional.
• Be extra vigilant regarding sugars and sugar control to avoid peaks and valleys wherever possible.
• Keep the immune system strong with at least 7-8 hours sleep and reduce stress levels whenever possible.
• Avoid crowds and handshaking.
• Wash hands regularly.

Possible therapies

There are currently no drugs that have been approved specifically for the treatment of COVID-19, although a vaccine against the disease is currently under development.

Dr. Gupta and his colleagues noted in their article that there have been reports of the anecdotal use of antiviral drugs such as lopinavir, ritonavir, interferon-beta, the RNA polymerase inhibitor remdesivir, and chloroquine.

However, Dr. Handelsman said that, as far as he knows, none of these drugs has been shown to be beneficial for COVID-19. “Some [providers] have tried Tamiflu, but with no clear outcomes, and for severely sick patients, they tried medications for anti-HIV, hepatitis C, and malaria, but so far, there has been no breakthrough.”

Dr. Cohen, Dr. Handelsman, Dr. Jellinger, Dr. Levy, and Dr. Rettinger are members of the editorial advisory board of Clinical Endocrinology News. Dr. Gupta and Dr. Wu, and their colleagues, reported no conflicts of interest.

[email protected]

Patients with diabetes may be at extra risk for coronavirus disease (COVID-19) mortality, and doctors treating them need to keep up with the latest guidelines and expert advice.

Most health advisories about COVID-19 mention diabetes as one of the high-risk categories for the disease, likely because early data coming out of China, where the disease was first reported, indicated an elevated case-fatality rate for COVID-19 patients who also had diabetes.

In an article published in JAMA, Zunyou Wu, MD, and Jennifer M. McGoogan, PhD, summarized the findings from a February report on 44,672 confirmed cases of the disease from the Chinese Center for Disease Control and Prevention. The overall case-fatality rate (CFR) at that stage was 2.3% (1,023 deaths of the 44,672 confirmed cases). The data indicated that the CFR was elevated among COVID-19 patients with preexisting comorbid conditions, specifically, cardiovascular disease (CFR, 10.5%), diabetes (7.3%), chronic respiratory disease (6.3%), hypertension (6%), and cancer (5.6%).

The data also showed an aged-related trend in the CFR, with patients aged 80 years or older having a CFR of 14.8% and those aged 70-79 years, a rate of 8.0%, while there were no fatal cases reported in patients aged 9 years or younger (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

Those findings have been echoed by the U.S. Centers of Disease Control and Prevention. The American Diabetes Association and the American Association of Clinical Endocrinologists have in turn referenced the CDC in their COVID-19 guidance recommendations for patients with diabetes.

Guidelines were already in place for treatment of infections in patients with diabetes, and at this stage, it seems that the same guidelines would extend to those patients who are also diagnosed with COVID-19, which is caused by the novel coronavirus, SARS-CoV-2.

In general, patients with diabetes – especially those whose disease is not controlled, or not well controlled – can be more susceptible to more common infections, such as influenza and pneumonia, possibly because hyperglycemia can subdue immunity by disrupting function of the white blood cells.
 

Glucose control is key

An important factor in any form of infection control in patients with diabetes seems to be whether or not a patient’s glucose levels are well controlled, according to comments from members of the editorial advisory board for Clinical Endocrinology News. Good glucose control, therefore, could be instrumental in reducing both the risk for and severity of infection.

Paul Jellinger, MD, of the Center for Diabetes & Endocrine Care, Hollywood, Fla., said that, over the years, he had not observed higher infection rates in general in patients with hemoglobin A_1c levels below 7, or even higher. However, “a bigger question for me, given the broad category of ‘diabetes’ listed as a risk for serious coronavirus complications by the CDC, has been: Just which individuals with diabetes are really at risk? Are patients with well-controlled diabetes at increased risk as much as those with significant hyperglycemia and uncontrolled diabetes? In my view, not likely.”

Alan Jay Cohen, MD, agreed with Dr. Jellinger. “Many patients have called the office in the last 10 days to ask if there are special precautions they should take because they are reading that they are in the high-risk group because they have diabetes. Many of them are in superb, or at least pretty good, control. I have not seen where they have had a higher incidence of infection than the general population, and I have not seen data with COVID-19 that specifically demonstrates that a person with diabetes in good control has an increased risk,” he said.

“My recommendations to these patients have been the same as those given to the general population,” added Dr. Cohen, medical director at Baptist Medical Group: The Endocrine Clinic, Memphis.

Herbert I. Rettinger, MD, also conceded that poorly controlled blood sugars and confounding illnesses, such as renal and cardiac conditions, are common in patients with long-standing diabetes, but “there is a huge population of patients with type 1 diabetes, and very few seem to be more susceptible to infection. Perhaps I am missing those with poor diet and glucose control.”

Philip Levy, MD, picked up on that latter point, emphasizing that “endocrinologists take care of fewer patients with diabetes than do primary care physicians. Most patients with type 2 diabetes are not seen by us unless the PCP has problems [treating them],” so it could be that PCPs may see a higher number of patients who are at a greater risk for infections.

Ultimately, “good glucose control is very helpful in avoiding infections,” said Dr. Levy, of the Banner University Medical Group Endocrinology & Diabetes, Phoenix.
 

For sick patients

Guidelines for patients at the Joslin Diabetes Center in Boston advise patients who are feeling sick to continue taking their diabetes medications, unless instructed otherwise by their providers, and to monitor their glucose more frequently because it can spike suddenly.

Patients with type 1 diabetes should check for ketones if their glucose passes 250 mg/dL, according to the guidelines, and patients should remain hydrated at all times and get plenty of rest.

“Sick-day guidelines definitely apply, but patients should be advised to get tested if they have any symptoms they are concerned about,” said Dr. Rettinger, of the Endocrinology Medical Group of Orange County, Orange, Calif.

If patients with diabetes develop COVID-19, then home management may still be possible, according to Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues (Diabetes Metab Syndr. 2020 Mar 10;14[3]:211-2. doi: 10.1016/j.dsx.2020.03.002).

Dr. Rettinger agreed, noting that home management would be feasible as long as “everything is going well, that is, the patient is not experiencing respiratory problems or difficulties in controlling glucose levels. Consider patients with type 1 diabetes who have COVID-19 as you would a nursing home patient – ever vigilant.”

Dr. Gupta and coauthors also recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve. However, the ADA warns in its guidelines that patients should “be aware that some constant glucose monitoring sensors (Dexcom G5, Medtronic Enlite, and Guardian) are impacted by acetaminophen (Tylenol), and that patients should check with finger sticks to ensure accuracy [if they are taking acetaminophen].”

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often, the authors wrote, cautioning that “frequent changes in dosage and correctional bolus may be required to maintain normoglycemia.” Dr Rettinger emphasized that “hyperglycemia, as always, is best treated with fluids and insulin and frequent checks of sugars to be sure the treatment regimen is successful.”

In regard to diabetic drug regimens, patients with type 1 or 2 disease should continue on their current medications, advised Yehuda Handelsman, MD. “Some, especially those on insulin, may require more of it. And the patient should increase fluid intake to prevent fluid depletion. We do not reduce antihyperglycemic medication to preserve fluids.

Preventive measures

In the interest of maintaining good glucose control, patients also should monitor their glucose levels more frequently so that fluctuations can be detected early and quickly addressed with the appropriate medication adjustments, according to guidelines from the ADA and AACE. They should continue to follow a healthy diet that includes adequate protein and they should exercise regularly.

Patients should ensure that they have enough medication and testing supplies – for at least 14 days, and longer, if costs permit – in case they have to go into quarantine.

General preventive measures, such as frequent hand washing with soap and water, practicing good respiratory hygiene by sneezing or coughing into a facial tissue or bent elbow, also apply for reducing the risk of infection. Touching of the face should be avoided, as should nonessential travel and contact with infected individuals.

Patients with diabetes should always be current with their influenza and pneumonia shots.

Dr. Rettinger said that he always recommends the following preventative measures to his patients and he is using the current health crisis to reinforce them:

• Eat lots of multicolored fruits and vegetables.
• Eat yogurt and take probiotics to keep the intestinal biome strong and functional.
• Be extra vigilant regarding sugars and sugar control to avoid peaks and valleys wherever possible.
• Keep the immune system strong with at least 7-8 hours sleep and reduce stress levels whenever possible.
• Avoid crowds and handshaking.
• Wash hands regularly.

Possible therapies

There are currently no drugs that have been approved specifically for the treatment of COVID-19, although a vaccine against the disease is currently under development.

Dr. Gupta and his colleagues noted in their article that there have been reports of the anecdotal use of antiviral drugs such as lopinavir, ritonavir, interferon-beta, the RNA polymerase inhibitor remdesivir, and chloroquine.

However, Dr. Handelsman said that, as far as he knows, none of these drugs has been shown to be beneficial for COVID-19. “Some [providers] have tried Tamiflu, but with no clear outcomes, and for severely sick patients, they tried medications for anti-HIV, hepatitis C, and malaria, but so far, there has been no breakthrough.”

Dr. Cohen, Dr. Handelsman, Dr. Jellinger, Dr. Levy, and Dr. Rettinger are members of the editorial advisory board of Clinical Endocrinology News. Dr. Gupta and Dr. Wu, and their colleagues, reported no conflicts of interest.

[email protected]

Patients with diabetes may be at extra risk for coronavirus disease (COVID-19) mortality, and doctors treating them need to keep up with the latest guidelines and expert advice.

Most health advisories about COVID-19 mention diabetes as one of the high-risk categories for the disease, likely because early data coming out of China, where the disease was first reported, indicated an elevated case-fatality rate for COVID-19 patients who also had diabetes.

In an article published in JAMA, Zunyou Wu, MD, and Jennifer M. McGoogan, PhD, summarized the findings from a February report on 44,672 confirmed cases of the disease from the Chinese Center for Disease Control and Prevention. The overall case-fatality rate (CFR) at that stage was 2.3% (1,023 deaths of the 44,672 confirmed cases). The data indicated that the CFR was elevated among COVID-19 patients with preexisting comorbid conditions, specifically, cardiovascular disease (CFR, 10.5%), diabetes (7.3%), chronic respiratory disease (6.3%), hypertension (6%), and cancer (5.6%).

The data also showed an aged-related trend in the CFR, with patients aged 80 years or older having a CFR of 14.8% and those aged 70-79 years, a rate of 8.0%, while there were no fatal cases reported in patients aged 9 years or younger (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

Those findings have been echoed by the U.S. Centers of Disease Control and Prevention. The American Diabetes Association and the American Association of Clinical Endocrinologists have in turn referenced the CDC in their COVID-19 guidance recommendations for patients with diabetes.

Guidelines were already in place for treatment of infections in patients with diabetes, and at this stage, it seems that the same guidelines would extend to those patients who are also diagnosed with COVID-19, which is caused by the novel coronavirus, SARS-CoV-2.

In general, patients with diabetes – especially those whose disease is not controlled, or not well controlled – can be more susceptible to more common infections, such as influenza and pneumonia, possibly because hyperglycemia can subdue immunity by disrupting function of the white blood cells.
 

Glucose control is key

An important factor in any form of infection control in patients with diabetes seems to be whether or not a patient’s glucose levels are well controlled, according to comments from members of the editorial advisory board for Clinical Endocrinology News. Good glucose control, therefore, could be instrumental in reducing both the risk for and severity of infection.

Paul Jellinger, MD, of the Center for Diabetes & Endocrine Care, Hollywood, Fla., said that, over the years, he had not observed higher infection rates in general in patients with hemoglobin A_1c levels below 7, or even higher. However, “a bigger question for me, given the broad category of ‘diabetes’ listed as a risk for serious coronavirus complications by the CDC, has been: Just which individuals with diabetes are really at risk? Are patients with well-controlled diabetes at increased risk as much as those with significant hyperglycemia and uncontrolled diabetes? In my view, not likely.”

Alan Jay Cohen, MD, agreed with Dr. Jellinger. “Many patients have called the office in the last 10 days to ask if there are special precautions they should take because they are reading that they are in the high-risk group because they have diabetes. Many of them are in superb, or at least pretty good, control. I have not seen where they have had a higher incidence of infection than the general population, and I have not seen data with COVID-19 that specifically demonstrates that a person with diabetes in good control has an increased risk,” he said.

“My recommendations to these patients have been the same as those given to the general population,” added Dr. Cohen, medical director at Baptist Medical Group: The Endocrine Clinic, Memphis.

Herbert I. Rettinger, MD, also conceded that poorly controlled blood sugars and confounding illnesses, such as renal and cardiac conditions, are common in patients with long-standing diabetes, but “there is a huge population of patients with type 1 diabetes, and very few seem to be more susceptible to infection. Perhaps I am missing those with poor diet and glucose control.”

Philip Levy, MD, picked up on that latter point, emphasizing that “endocrinologists take care of fewer patients with diabetes than do primary care physicians. Most patients with type 2 diabetes are not seen by us unless the PCP has problems [treating them],” so it could be that PCPs may see a higher number of patients who are at a greater risk for infections.

Ultimately, “good glucose control is very helpful in avoiding infections,” said Dr. Levy, of the Banner University Medical Group Endocrinology & Diabetes, Phoenix.
 

For sick patients

Guidelines for patients at the Joslin Diabetes Center in Boston advise patients who are feeling sick to continue taking their diabetes medications, unless instructed otherwise by their providers, and to monitor their glucose more frequently because it can spike suddenly.

Patients with type 1 diabetes should check for ketones if their glucose passes 250 mg/dL, according to the guidelines, and patients should remain hydrated at all times and get plenty of rest.

“Sick-day guidelines definitely apply, but patients should be advised to get tested if they have any symptoms they are concerned about,” said Dr. Rettinger, of the Endocrinology Medical Group of Orange County, Orange, Calif.

If patients with diabetes develop COVID-19, then home management may still be possible, according to Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues (Diabetes Metab Syndr. 2020 Mar 10;14[3]:211-2. doi: 10.1016/j.dsx.2020.03.002).

Dr. Rettinger agreed, noting that home management would be feasible as long as “everything is going well, that is, the patient is not experiencing respiratory problems or difficulties in controlling glucose levels. Consider patients with type 1 diabetes who have COVID-19 as you would a nursing home patient – ever vigilant.”

Dr. Gupta and coauthors also recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve. However, the ADA warns in its guidelines that patients should “be aware that some constant glucose monitoring sensors (Dexcom G5, Medtronic Enlite, and Guardian) are impacted by acetaminophen (Tylenol), and that patients should check with finger sticks to ensure accuracy [if they are taking acetaminophen].”

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often, the authors wrote, cautioning that “frequent changes in dosage and correctional bolus may be required to maintain normoglycemia.” Dr Rettinger emphasized that “hyperglycemia, as always, is best treated with fluids and insulin and frequent checks of sugars to be sure the treatment regimen is successful.”

In regard to diabetic drug regimens, patients with type 1 or 2 disease should continue on their current medications, advised Yehuda Handelsman, MD. “Some, especially those on insulin, may require more of it. And the patient should increase fluid intake to prevent fluid depletion. We do not reduce antihyperglycemic medication to preserve fluids.

Preventive measures

In the interest of maintaining good glucose control, patients also should monitor their glucose levels more frequently so that fluctuations can be detected early and quickly addressed with the appropriate medication adjustments, according to guidelines from the ADA and AACE. They should continue to follow a healthy diet that includes adequate protein and they should exercise regularly.

Patients should ensure that they have enough medication and testing supplies – for at least 14 days, and longer, if costs permit – in case they have to go into quarantine.

General preventive measures, such as frequent hand washing with soap and water, practicing good respiratory hygiene by sneezing or coughing into a facial tissue or bent elbow, also apply for reducing the risk of infection. Touching of the face should be avoided, as should nonessential travel and contact with infected individuals.

Patients with diabetes should always be current with their influenza and pneumonia shots.

Dr. Rettinger said that he always recommends the following preventative measures to his patients and he is using the current health crisis to reinforce them:

• Eat lots of multicolored fruits and vegetables.
• Eat yogurt and take probiotics to keep the intestinal biome strong and functional.
• Be extra vigilant regarding sugars and sugar control to avoid peaks and valleys wherever possible.
• Keep the immune system strong with at least 7-8 hours sleep and reduce stress levels whenever possible.
• Avoid crowds and handshaking.
• Wash hands regularly.

Possible therapies

There are currently no drugs that have been approved specifically for the treatment of COVID-19, although a vaccine against the disease is currently under development.

Dr. Gupta and his colleagues noted in their article that there have been reports of the anecdotal use of antiviral drugs such as lopinavir, ritonavir, interferon-beta, the RNA polymerase inhibitor remdesivir, and chloroquine.

However, Dr. Handelsman said that, as far as he knows, none of these drugs has been shown to be beneficial for COVID-19. “Some [providers] have tried Tamiflu, but with no clear outcomes, and for severely sick patients, they tried medications for anti-HIV, hepatitis C, and malaria, but so far, there has been no breakthrough.”

Dr. Cohen, Dr. Handelsman, Dr. Jellinger, Dr. Levy, and Dr. Rettinger are members of the editorial advisory board of Clinical Endocrinology News. Dr. Gupta and Dr. Wu, and their colleagues, reported no conflicts of interest.

[email protected]

Patients with diabetes may have an increased risk of developing coronavirus infection (COVID-19), along with increased risks of morbidity and mortality, according to researchers writing in Diabetes & Metabolic Syndrome.

Although relevant clinical data remain scarce, patients with diabetes should take extra precautions to avoid infection and, if infected, may require special care, reported Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues.

“The disease severity [with COVID-19] has varied from mild, self-limiting, flu-like illness to fulminant pneumonia, respiratory failure, and death,” the authors wrote.

As of March 16, 2020, the World Health Organization reported 167,515 confirmed cases of COVID-19 and 6,606 deaths from around the world, with a mortality rate of 3.9%. But the actual mortality rate may be lower, the authors suggested, because a study involving more than 1,000 confirmed cases reported a mortality rate of 1.4%.

“Considering that the number of unreported and unconfirmed cases is likely to be much higher than the reported cases, the actual mortality may be less than 1%, which is similar to that of severe seasonal influenza,” the authors said, in reference to an editorial by Anthony S. Fauci, MD, and colleagues in the New England Journal of Medicine. In addition, they noted, mortality rates may vary by region.

The largest study relevant to patients with diabetes, which involved 72,314 cases of COVID-19, showed that patients with diabetes had a threefold higher mortality rate than did those without diabetes (7.3% vs. 2.3%, respectively). These figures were reported by the Chinese Centre for Disease Control and Prevention.

However, data from smaller cohorts with diabetes and COVID-19 have yielded mixed results. For instance, one study, involving 140 patients from Wuhan, suggested that diabetes was not a risk factor for severe disease, and in an analysis of 11 studies reporting on laboratory abnormalities in patients with a diagnosis of COVID-19, raised blood sugar levels or diabetes were not mentioned among the predictors of severe disease.

“Our knowledge about the prevalence of COVID-19 and disease course in people with diabetes will evolve as more detailed analyses are carried out,” the authors wrote. “For now, it is reasonable to assume that people with diabetes are at increased risk of developing infection. Coexisting heart disease, kidney disease, advanced age, and frailty are likely to further increase the severity of disease.”
 

Prevention first

“It is important that people with diabetes maintain good glycemic control, because it might help in reducing the risk of infection and the severity,” the authors wrote.

In addition to more frequent monitoring of blood glucose levels, they recommended other preventive measures, such as getting adequate nutrition, exercising, and being current with vaccinations for influenza and pneumonia. The latter, they said, may also reduce the risk of secondary bacterial pneumonia after a respiratory viral infection.

In regard to nutrition, adequate protein intake is important and “any deficiencies of minerals and vitamins need to be taken care of,” they advised. Likewise, exercise is known to improve immunity and should continue, but they suggest avoiding gyms and swimming pools.

For patients with coexisting heart and/or kidney disease, they also recommended efforts to stabilize cardiac/renal status.

In addition, the general preventive measures, such as regular and thorough hand washing with soap and water, practicing good respiratory hygiene by sneezing and coughing into a bent elbow or a facial tissue, and avoiding contact with anyone who is infected, should be observed.

As with other patients with chronic diseases that are managed long-term medications, patients with diabetes should always ensure that they have a sufficient supply of their medications and refills, if possible.
 

After a diagnosis

If patients with diabetes develop COVID-19, then home management may still be possible, wrote the authors, who recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve.

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often. “Frequent changes in dosage and correctional bolus may be required to maintain normoglycemia,” they cautioned.

Concerning diabetic drug regimens, they suggest patients avoid antihyperglycemic agents that can cause volume depletion or hypoglycemia and, if necessary, that they reduce oral antidiabetic drugs and follow sick-day guidelines.

For hospitalized patients, the investigators strengthened that statement, advising that oral agents need to be stopped, particularly sodium-glucose cotransporter 2 inhibitors and metformin. “Insulin is the preferred agent for control of hyperglycemia in hospitalized sick patients,” they wrote.

Untested therapies

The authors also discussed a range of untested therapies that may help fight COVID-19, such as antiviral drugs (such as lopinavir and ritonavir), zinc nanoparticles, and vitamin C. Supplementing those recommendations, Dr. Gupta and colleagues provided a concise review of COVID-19 epidemiology and extant data relevant to patients with diabetes.

The investigators reported no conflicts of interest.

SOURCE: Gupta et al. Diabetes Metab Syndr. 2020;14(3):211-12.

Patients with diabetes may have an increased risk of developing coronavirus infection (COVID-19), along with increased risks of morbidity and mortality, according to researchers writing in Diabetes & Metabolic Syndrome.

Although relevant clinical data remain scarce, patients with diabetes should take extra precautions to avoid infection and, if infected, may require special care, reported Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues.

“The disease severity [with COVID-19] has varied from mild, self-limiting, flu-like illness to fulminant pneumonia, respiratory failure, and death,” the authors wrote.

As of March 16, 2020, the World Health Organization reported 167,515 confirmed cases of COVID-19 and 6,606 deaths from around the world, with a mortality rate of 3.9%. But the actual mortality rate may be lower, the authors suggested, because a study involving more than 1,000 confirmed cases reported a mortality rate of 1.4%.

“Considering that the number of unreported and unconfirmed cases is likely to be much higher than the reported cases, the actual mortality may be less than 1%, which is similar to that of severe seasonal influenza,” the authors said, in reference to an editorial by Anthony S. Fauci, MD, and colleagues in the New England Journal of Medicine. In addition, they noted, mortality rates may vary by region.

The largest study relevant to patients with diabetes, which involved 72,314 cases of COVID-19, showed that patients with diabetes had a threefold higher mortality rate than did those without diabetes (7.3% vs. 2.3%, respectively). These figures were reported by the Chinese Centre for Disease Control and Prevention.

However, data from smaller cohorts with diabetes and COVID-19 have yielded mixed results. For instance, one study, involving 140 patients from Wuhan, suggested that diabetes was not a risk factor for severe disease, and in an analysis of 11 studies reporting on laboratory abnormalities in patients with a diagnosis of COVID-19, raised blood sugar levels or diabetes were not mentioned among the predictors of severe disease.

“Our knowledge about the prevalence of COVID-19 and disease course in people with diabetes will evolve as more detailed analyses are carried out,” the authors wrote. “For now, it is reasonable to assume that people with diabetes are at increased risk of developing infection. Coexisting heart disease, kidney disease, advanced age, and frailty are likely to further increase the severity of disease.”
 

Prevention first

“It is important that people with diabetes maintain good glycemic control, because it might help in reducing the risk of infection and the severity,” the authors wrote.

In addition to more frequent monitoring of blood glucose levels, they recommended other preventive measures, such as getting adequate nutrition, exercising, and being current with vaccinations for influenza and pneumonia. The latter, they said, may also reduce the risk of secondary bacterial pneumonia after a respiratory viral infection.

In regard to nutrition, adequate protein intake is important and “any deficiencies of minerals and vitamins need to be taken care of,” they advised. Likewise, exercise is known to improve immunity and should continue, but they suggest avoiding gyms and swimming pools.

For patients with coexisting heart and/or kidney disease, they also recommended efforts to stabilize cardiac/renal status.

In addition, the general preventive measures, such as regular and thorough hand washing with soap and water, practicing good respiratory hygiene by sneezing and coughing into a bent elbow or a facial tissue, and avoiding contact with anyone who is infected, should be observed.

As with other patients with chronic diseases that are managed long-term medications, patients with diabetes should always ensure that they have a sufficient supply of their medications and refills, if possible.
 

After a diagnosis

If patients with diabetes develop COVID-19, then home management may still be possible, wrote the authors, who recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve.

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often. “Frequent changes in dosage and correctional bolus may be required to maintain normoglycemia,” they cautioned.

Concerning diabetic drug regimens, they suggest patients avoid antihyperglycemic agents that can cause volume depletion or hypoglycemia and, if necessary, that they reduce oral antidiabetic drugs and follow sick-day guidelines.

For hospitalized patients, the investigators strengthened that statement, advising that oral agents need to be stopped, particularly sodium-glucose cotransporter 2 inhibitors and metformin. “Insulin is the preferred agent for control of hyperglycemia in hospitalized sick patients,” they wrote.

Untested therapies

The authors also discussed a range of untested therapies that may help fight COVID-19, such as antiviral drugs (such as lopinavir and ritonavir), zinc nanoparticles, and vitamin C. Supplementing those recommendations, Dr. Gupta and colleagues provided a concise review of COVID-19 epidemiology and extant data relevant to patients with diabetes.

The investigators reported no conflicts of interest.

SOURCE: Gupta et al. Diabetes Metab Syndr. 2020;14(3):211-12.

Patients with diabetes may have an increased risk of developing coronavirus infection (COVID-19), along with increased risks of morbidity and mortality, according to researchers writing in Diabetes & Metabolic Syndrome.

Although relevant clinical data remain scarce, patients with diabetes should take extra precautions to avoid infection and, if infected, may require special care, reported Ritesh Gupta, MD, of Fortis C-DOC Hospital, New Delhi, and colleagues.

“The disease severity [with COVID-19] has varied from mild, self-limiting, flu-like illness to fulminant pneumonia, respiratory failure, and death,” the authors wrote.

As of March 16, 2020, the World Health Organization reported 167,515 confirmed cases of COVID-19 and 6,606 deaths from around the world, with a mortality rate of 3.9%. But the actual mortality rate may be lower, the authors suggested, because a study involving more than 1,000 confirmed cases reported a mortality rate of 1.4%.

“Considering that the number of unreported and unconfirmed cases is likely to be much higher than the reported cases, the actual mortality may be less than 1%, which is similar to that of severe seasonal influenza,” the authors said, in reference to an editorial by Anthony S. Fauci, MD, and colleagues in the New England Journal of Medicine. In addition, they noted, mortality rates may vary by region.

The largest study relevant to patients with diabetes, which involved 72,314 cases of COVID-19, showed that patients with diabetes had a threefold higher mortality rate than did those without diabetes (7.3% vs. 2.3%, respectively). These figures were reported by the Chinese Centre for Disease Control and Prevention.

However, data from smaller cohorts with diabetes and COVID-19 have yielded mixed results. For instance, one study, involving 140 patients from Wuhan, suggested that diabetes was not a risk factor for severe disease, and in an analysis of 11 studies reporting on laboratory abnormalities in patients with a diagnosis of COVID-19, raised blood sugar levels or diabetes were not mentioned among the predictors of severe disease.

“Our knowledge about the prevalence of COVID-19 and disease course in people with diabetes will evolve as more detailed analyses are carried out,” the authors wrote. “For now, it is reasonable to assume that people with diabetes are at increased risk of developing infection. Coexisting heart disease, kidney disease, advanced age, and frailty are likely to further increase the severity of disease.”
 

Prevention first

“It is important that people with diabetes maintain good glycemic control, because it might help in reducing the risk of infection and the severity,” the authors wrote.

In addition to more frequent monitoring of blood glucose levels, they recommended other preventive measures, such as getting adequate nutrition, exercising, and being current with vaccinations for influenza and pneumonia. The latter, they said, may also reduce the risk of secondary bacterial pneumonia after a respiratory viral infection.

In regard to nutrition, adequate protein intake is important and “any deficiencies of minerals and vitamins need to be taken care of,” they advised. Likewise, exercise is known to improve immunity and should continue, but they suggest avoiding gyms and swimming pools.

For patients with coexisting heart and/or kidney disease, they also recommended efforts to stabilize cardiac/renal status.

In addition, the general preventive measures, such as regular and thorough hand washing with soap and water, practicing good respiratory hygiene by sneezing and coughing into a bent elbow or a facial tissue, and avoiding contact with anyone who is infected, should be observed.

As with other patients with chronic diseases that are managed long-term medications, patients with diabetes should always ensure that they have a sufficient supply of their medications and refills, if possible.
 

After a diagnosis

If patients with diabetes develop COVID-19, then home management may still be possible, wrote the authors, who recommended basic treatment measures such as maintaining hydration and managing symptoms with acetaminophen and steam inhalation, and home isolation for 14 days or until the symptoms resolve.

In the event of hyperglycemia with fever in patients with type 1 diabetes, blood glucose and urinary ketones should be monitored often. “Frequent changes in dosage and correctional bolus may be required to maintain normoglycemia,” they cautioned.

Concerning diabetic drug regimens, they suggest patients avoid antihyperglycemic agents that can cause volume depletion or hypoglycemia and, if necessary, that they reduce oral antidiabetic drugs and follow sick-day guidelines.

For hospitalized patients, the investigators strengthened that statement, advising that oral agents need to be stopped, particularly sodium-glucose cotransporter 2 inhibitors and metformin. “Insulin is the preferred agent for control of hyperglycemia in hospitalized sick patients,” they wrote.

Untested therapies

The authors also discussed a range of untested therapies that may help fight COVID-19, such as antiviral drugs (such as lopinavir and ritonavir), zinc nanoparticles, and vitamin C. Supplementing those recommendations, Dr. Gupta and colleagues provided a concise review of COVID-19 epidemiology and extant data relevant to patients with diabetes.

The investigators reported no conflicts of interest.

SOURCE: Gupta et al. Diabetes Metab Syndr. 2020;14(3):211-12.

The Food and Drug Administration announced three measures aimed at improving the testing capacity for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

First, the FDA is giving states more flexibility to approve and implement testing for COVID-19.

“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” agency Commissioner Stephen Hahn, MD, said in a March 16 statement announcing the policy updates. “Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA.”

A copy of the updated guidance document can be found here.

Dr. Hahn added that laboratories working within this authority granted to states will not have to pursue an emergency use authorization (EUA). New York state was previously granted a waiver to allow for more state oversight over the introduction of diagnostic testing.

Second, the FDA is expanding guidance issued on Feb. 29 on who can develop diagnostic tests. Originally, the Feb. 29 guidance was aimed at labs certified to perform high-complexity testing consistent with requirements outlined in the Clinical Laboratory Improvement Amendments.

“Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances,” Commissioner Hahn said, adding that a number of commercial manufacturers are developing tests for the coronavirus with the intent of submitting an EUA request.

“During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test while the manufacturer is preparing its EUA request,” he added.

The updated guidance also provides recommendations for test developers working on serologic tests for COVID-19.

During a March 16 conference call with reporters, Commissioner Hahn said the flexibility would add a “significant number of tests and we believe this will be a surge to meet the demand that we expect to see, although it is somewhat difficult” to quantify the number of tests this new flexibility will bring to the market.

[email protected]

The Food and Drug Administration announced three measures aimed at improving the testing capacity for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

First, the FDA is giving states more flexibility to approve and implement testing for COVID-19.

“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” agency Commissioner Stephen Hahn, MD, said in a March 16 statement announcing the policy updates. “Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA.”

A copy of the updated guidance document can be found here.

Dr. Hahn added that laboratories working within this authority granted to states will not have to pursue an emergency use authorization (EUA). New York state was previously granted a waiver to allow for more state oversight over the introduction of diagnostic testing.

Second, the FDA is expanding guidance issued on Feb. 29 on who can develop diagnostic tests. Originally, the Feb. 29 guidance was aimed at labs certified to perform high-complexity testing consistent with requirements outlined in the Clinical Laboratory Improvement Amendments.

“Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances,” Commissioner Hahn said, adding that a number of commercial manufacturers are developing tests for the coronavirus with the intent of submitting an EUA request.

“During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test while the manufacturer is preparing its EUA request,” he added.

The updated guidance also provides recommendations for test developers working on serologic tests for COVID-19.

During a March 16 conference call with reporters, Commissioner Hahn said the flexibility would add a “significant number of tests and we believe this will be a surge to meet the demand that we expect to see, although it is somewhat difficult” to quantify the number of tests this new flexibility will bring to the market.

[email protected]

The Food and Drug Administration announced three measures aimed at improving the testing capacity for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

First, the FDA is giving states more flexibility to approve and implement testing for COVID-19.

“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” agency Commissioner Stephen Hahn, MD, said in a March 16 statement announcing the policy updates. “Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA.”

A copy of the updated guidance document can be found here.

Dr. Hahn added that laboratories working within this authority granted to states will not have to pursue an emergency use authorization (EUA). New York state was previously granted a waiver to allow for more state oversight over the introduction of diagnostic testing.

Second, the FDA is expanding guidance issued on Feb. 29 on who can develop diagnostic tests. Originally, the Feb. 29 guidance was aimed at labs certified to perform high-complexity testing consistent with requirements outlined in the Clinical Laboratory Improvement Amendments.

“Under the update published today, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances,” Commissioner Hahn said, adding that a number of commercial manufacturers are developing tests for the coronavirus with the intent of submitting an EUA request.

“During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test while the manufacturer is preparing its EUA request,” he added.

The updated guidance also provides recommendations for test developers working on serologic tests for COVID-19.

During a March 16 conference call with reporters, Commissioner Hahn said the flexibility would add a “significant number of tests and we believe this will be a surge to meet the demand that we expect to see, although it is somewhat difficult” to quantify the number of tests this new flexibility will bring to the market.

[email protected]

Adding pemetrexed to bevacizumab maintenance improved progression-free survival (PFS), but not overall survival (OS), in a phase 3 trial of patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

However, the addition of pemetrexed to bevacizumab maintenance improved OS for patients with wild-type EGFR, reported Takashi Seto, MD, of the National Kyushu Cancer Center, Japan, and colleagues. Their report was published in the Journal of Clinical Oncology.

The researchers conducted a phase 3 trial of 599 patients with previously untreated, advanced nonsquamous NSCLC. Patients were randomly allocated to receive maintenance with either pemetrexed (500 mg/m²) and bevacizumab (15 mg/kg) or bevacizumab alone (15 mg/kg once every 3 weeks).

Prior to starting maintenance, patients received induction with carboplatin, pemetrexed, and bevacizumab. Both interventions were maintained until unacceptable toxicity, disease progression, death, or withdrawal for other reasons.

The primary outcome was OS, measured from the time of randomization until death from any cause. Secondary outcomes included PFS and safety.
 

Survival

Overall, there was no significant difference in OS between the treatment arms. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 19.6 months in the bevacizumab arm (hazard ratio, 0.87; P = .069).

However, OS was significantly prolonged for patients with wild-type EGFR who received pemetrexed plus bevacizumab. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 18.8 months in the bevacizumab arm (HR, 0.82; P = .020).

For the entire cohort, PFS was significantly better in the pemetrexed-bevacizumab arm. The median PFS was 5.7 months in the pemetrexed-bevacizumab arm and 4.0 months in the bevacizumab arm (HR, 0.67; P < .001).
 

Safety

In the pemetrexed-bevacizumab arm, the most common grade 3 or higher adverse events were low neutrophil count (14.0%), hypertension (11.7%), and low white blood cell count (5.4%).

Treatment-related deaths occurred in four patients receiving pemetrexed-bevacizumab maintenance. The causes of death were interstitial pneumonitis (n = 2), alveolar hemorrhage, and lung infection.

“The safety profile obtained in this study was predictable and similar to previous reports,” the researchers wrote. They acknowledged that bevacizumab-induced hypertension was commonly observed but was not problematic from a clinical perspective.

Based on these results, the researchers concluded that pemetrexed plus bevacizumab maintenance is “useful” in patients with advanced nonsquamous NSCLC, especially in patients with wild-type EGFR.

This study was supported, in part, by Eli Lilly Japan KK. The authors disclosed financial affiliations with Eli Lilly and other companies.

SOURCE: Seto T et al. J Clin Oncol. 2020 Mar 10;38(8):793-803.

Adding pemetrexed to bevacizumab maintenance improved progression-free survival (PFS), but not overall survival (OS), in a phase 3 trial of patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

However, the addition of pemetrexed to bevacizumab maintenance improved OS for patients with wild-type EGFR, reported Takashi Seto, MD, of the National Kyushu Cancer Center, Japan, and colleagues. Their report was published in the Journal of Clinical Oncology.

The researchers conducted a phase 3 trial of 599 patients with previously untreated, advanced nonsquamous NSCLC. Patients were randomly allocated to receive maintenance with either pemetrexed (500 mg/m²) and bevacizumab (15 mg/kg) or bevacizumab alone (15 mg/kg once every 3 weeks).

Prior to starting maintenance, patients received induction with carboplatin, pemetrexed, and bevacizumab. Both interventions were maintained until unacceptable toxicity, disease progression, death, or withdrawal for other reasons.

The primary outcome was OS, measured from the time of randomization until death from any cause. Secondary outcomes included PFS and safety.
 

Survival

Overall, there was no significant difference in OS between the treatment arms. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 19.6 months in the bevacizumab arm (hazard ratio, 0.87; P = .069).

However, OS was significantly prolonged for patients with wild-type EGFR who received pemetrexed plus bevacizumab. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 18.8 months in the bevacizumab arm (HR, 0.82; P = .020).

For the entire cohort, PFS was significantly better in the pemetrexed-bevacizumab arm. The median PFS was 5.7 months in the pemetrexed-bevacizumab arm and 4.0 months in the bevacizumab arm (HR, 0.67; P < .001).
 

Safety

In the pemetrexed-bevacizumab arm, the most common grade 3 or higher adverse events were low neutrophil count (14.0%), hypertension (11.7%), and low white blood cell count (5.4%).

Treatment-related deaths occurred in four patients receiving pemetrexed-bevacizumab maintenance. The causes of death were interstitial pneumonitis (n = 2), alveolar hemorrhage, and lung infection.

“The safety profile obtained in this study was predictable and similar to previous reports,” the researchers wrote. They acknowledged that bevacizumab-induced hypertension was commonly observed but was not problematic from a clinical perspective.

Based on these results, the researchers concluded that pemetrexed plus bevacizumab maintenance is “useful” in patients with advanced nonsquamous NSCLC, especially in patients with wild-type EGFR.

This study was supported, in part, by Eli Lilly Japan KK. The authors disclosed financial affiliations with Eli Lilly and other companies.

SOURCE: Seto T et al. J Clin Oncol. 2020 Mar 10;38(8):793-803.

Adding pemetrexed to bevacizumab maintenance improved progression-free survival (PFS), but not overall survival (OS), in a phase 3 trial of patients with advanced nonsquamous non–small cell lung cancer (NSCLC).

However, the addition of pemetrexed to bevacizumab maintenance improved OS for patients with wild-type EGFR, reported Takashi Seto, MD, of the National Kyushu Cancer Center, Japan, and colleagues. Their report was published in the Journal of Clinical Oncology.

The researchers conducted a phase 3 trial of 599 patients with previously untreated, advanced nonsquamous NSCLC. Patients were randomly allocated to receive maintenance with either pemetrexed (500 mg/m²) and bevacizumab (15 mg/kg) or bevacizumab alone (15 mg/kg once every 3 weeks).

Prior to starting maintenance, patients received induction with carboplatin, pemetrexed, and bevacizumab. Both interventions were maintained until unacceptable toxicity, disease progression, death, or withdrawal for other reasons.

The primary outcome was OS, measured from the time of randomization until death from any cause. Secondary outcomes included PFS and safety.
 

Survival

Overall, there was no significant difference in OS between the treatment arms. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 19.6 months in the bevacizumab arm (hazard ratio, 0.87; P = .069).

However, OS was significantly prolonged for patients with wild-type EGFR who received pemetrexed plus bevacizumab. The median OS was 23.3 months in the pemetrexed-bevacizumab arm and 18.8 months in the bevacizumab arm (HR, 0.82; P = .020).

For the entire cohort, PFS was significantly better in the pemetrexed-bevacizumab arm. The median PFS was 5.7 months in the pemetrexed-bevacizumab arm and 4.0 months in the bevacizumab arm (HR, 0.67; P < .001).
 

Safety

In the pemetrexed-bevacizumab arm, the most common grade 3 or higher adverse events were low neutrophil count (14.0%), hypertension (11.7%), and low white blood cell count (5.4%).

Treatment-related deaths occurred in four patients receiving pemetrexed-bevacizumab maintenance. The causes of death were interstitial pneumonitis (n = 2), alveolar hemorrhage, and lung infection.

“The safety profile obtained in this study was predictable and similar to previous reports,” the researchers wrote. They acknowledged that bevacizumab-induced hypertension was commonly observed but was not problematic from a clinical perspective.

Based on these results, the researchers concluded that pemetrexed plus bevacizumab maintenance is “useful” in patients with advanced nonsquamous NSCLC, especially in patients with wild-type EGFR.

This study was supported, in part, by Eli Lilly Japan KK. The authors disclosed financial affiliations with Eli Lilly and other companies.

SOURCE: Seto T et al. J Clin Oncol. 2020 Mar 10;38(8):793-803.

With new developments daily and lingering uncertainty about COVID-19, questions about testing and treatment for the coronavirus are at the forefront.

To address these top questions, Jay C. Butler, MD, deputy director for infectious diseases at the Centers for Disease Control and Prevention, sat down with JAMA editor Howard Bauchner, MD, to discuss the latest data on COVID-19 and to outline updated guidance from the agency. The following question-and-answer session was part of a live stream interview hosted by JAMA on March 16, 2020. The questions have been edited for length and clarity.
 

What test is being used to identify COVID-19?

In the United States, the most common and widely available test is the RT-polymerase chain reaction (rRT-PCR), which over the past few weeks has become available at public health labs across the country, Dr. Butler said during the JAMA interview. Capacity for the test is now possible in all 50 states and in Washington, D.C.

“More recently, there’s been a number of commercial labs that have come online to be able to do the testing,” Dr. Butler said. “Additionally, a number of academic centers are now able to run [Food and Drug Administration]–approved testing using slightly different PCR platforms.”
 

How accurate is the test?

Dr. Butler called PCR the “gold standard,” for testing COVID-19, and said it’s safe to say the test’s likelihood of identifying infection or past infection is extremely high. However, data on test sensitivity is limited.

“This may be frustrating to those of us who really like to know specifics of how to interpret the test results, but it’s important to keep in mind, we’re talking about a virus that we didn’t know existed 3 months ago,” he said.
 

At what point does a person with coronavirus test positive?

When exactly a test becomes positive is an unknown, Dr. Butler said. The assumption is that a patient who tests positive is more likely to be infectious, and data suggest the level of infectiousness is greatest after the onset of symptoms.

“There is at least some anecdotal reports that suggest that transmission could occur before onset of symptoms, but the data is still very limited,” he said. “Of course that has big implications in terms of how well we can really slow the spread of the virus.”
 

Who should get tested?

Dr. Butler said the focus should be individuals who are symptomatic with evidence of respiratory tract infection. People who are concerned about the virus and want a test are not the target.

“It’s important when talking to patients to help them to understand, this is different than a test for HIV or hepatitis C, where much of the message is: ‘Please get tested.’ ” he said. “This a situation where we’re trying to diagnose an acute infection. We do have a resource that may become limited again as some of the equipment required for running the test or collecting the specimen may come into short supply, so we want to focus on those people who are symptomatic and particularly on people who may be at higher risk of more severe illness.”
 

If a previously infected patient tests negative, can they still shed virus?

The CDC is currently analyzing how a negative PCR test relates to viral load, according to Dr. Butler. He added there have been situations in which a patient has twice tested negative for the virus, but a third swab resulted in a weakly positive result.

“It’s not clear if those are people who are actually infectious,” he said. “The PCR is detecting viral RNA, it doesn’t necessarily indicate there is viable virus present in the respiratory tract. So in general, I think it is safe to go back to work, but a positive test in a situation like that can be very difficult to interpret because we think it probably doesn’t reflect infectivity, but we don’t know for sure.”
 

Do we have an adequate supply of tests in the United States?

The CDC has addressed supply concerns by broadening the number of PCR platforms that can be used to run COVID-19 analyses, Dr. Butler said. Expansion of these platforms has been one way the government is furthering testing options and enabling consumer labs and academic centers to contribute to testing.

When can people who test positive go back to work?

The CDC is still researching that question and reviewing the data, Dr. Butler said. The current recommendation is that a patient who tests positive is considered clear to return to work after two negative tests at least 24 hours apart, following the resolution of symptoms. The CDC has not yet made an official recommendation on an exact time frame, but the CDC is considering a 14-day minimum of quarantine.

“The one caveat I’ll add is that someone who is a health care worker, even if they have resolved symptoms, it’s still a good idea to wear a surgical mask [when they return to work], just as an extra precaution.”
 

What do we know about immunity? Can patients get reinfected?

Long-term immunity after exposure and infection is virtually unknown, Dr. Butler said. Investigators know those with COVID-19 have an antibody response, but whether that is protective or not, is unclear. In regard to older coronaviruses, such as those that cause colds, patients generally develop an antibody response and may have a period of immunity, but that immunity eventually wanes and reinfection can occur.

What is the latest on therapies?

A number of trials are underway in China and in the United States to test possible therapies for COVID-19, Dr. Butler said. One of the candidate drugs is the broad spectrum antiviral drug remdesivir, which was developed for the treatment of the Ebola virus. Additionally, the National Institutes of Health is studying the potential for monoclonal antibodies to treat COVID-19.

“Of course these are drugs not yet FDA approved,” he said. “We all want to have them in our toolbox as soon as possible, but we want to make sure these drugs are going to benefit and not harm, and that they really do have the utility that we hope for.”
 

Is there specific guidance for healthcare workers about COVID-19?

Health care workers have a much higher likelihood of being exposed or exposing others who are at high risk of severe infection, Dr. Butler said. That’s why, if a health care worker becomes infected and recovers, it’s still important to take extra precautions when going back to work, such as wearing a mask.

“These are recommendations that are in-draft,” he said. “I want to be clear, I’m floating concepts out there that people can consider. ... I recognize as a former infection control medical director at a hospital that sometimes you have to adapt those guidelines based on your local conditions.”

[email protected]

With new developments daily and lingering uncertainty about COVID-19, questions about testing and treatment for the coronavirus are at the forefront.

To address these top questions, Jay C. Butler, MD, deputy director for infectious diseases at the Centers for Disease Control and Prevention, sat down with JAMA editor Howard Bauchner, MD, to discuss the latest data on COVID-19 and to outline updated guidance from the agency. The following question-and-answer session was part of a live stream interview hosted by JAMA on March 16, 2020. The questions have been edited for length and clarity.
 

What test is being used to identify COVID-19?

In the United States, the most common and widely available test is the RT-polymerase chain reaction (rRT-PCR), which over the past few weeks has become available at public health labs across the country, Dr. Butler said during the JAMA interview. Capacity for the test is now possible in all 50 states and in Washington, D.C.

“More recently, there’s been a number of commercial labs that have come online to be able to do the testing,” Dr. Butler said. “Additionally, a number of academic centers are now able to run [Food and Drug Administration]–approved testing using slightly different PCR platforms.”
 

How accurate is the test?

Dr. Butler called PCR the “gold standard,” for testing COVID-19, and said it’s safe to say the test’s likelihood of identifying infection or past infection is extremely high. However, data on test sensitivity is limited.

“This may be frustrating to those of us who really like to know specifics of how to interpret the test results, but it’s important to keep in mind, we’re talking about a virus that we didn’t know existed 3 months ago,” he said.
 

At what point does a person with coronavirus test positive?

When exactly a test becomes positive is an unknown, Dr. Butler said. The assumption is that a patient who tests positive is more likely to be infectious, and data suggest the level of infectiousness is greatest after the onset of symptoms.

“There is at least some anecdotal reports that suggest that transmission could occur before onset of symptoms, but the data is still very limited,” he said. “Of course that has big implications in terms of how well we can really slow the spread of the virus.”
 

Who should get tested?

Dr. Butler said the focus should be individuals who are symptomatic with evidence of respiratory tract infection. People who are concerned about the virus and want a test are not the target.

“It’s important when talking to patients to help them to understand, this is different than a test for HIV or hepatitis C, where much of the message is: ‘Please get tested.’ ” he said. “This a situation where we’re trying to diagnose an acute infection. We do have a resource that may become limited again as some of the equipment required for running the test or collecting the specimen may come into short supply, so we want to focus on those people who are symptomatic and particularly on people who may be at higher risk of more severe illness.”
 

If a previously infected patient tests negative, can they still shed virus?

The CDC is currently analyzing how a negative PCR test relates to viral load, according to Dr. Butler. He added there have been situations in which a patient has twice tested negative for the virus, but a third swab resulted in a weakly positive result.

“It’s not clear if those are people who are actually infectious,” he said. “The PCR is detecting viral RNA, it doesn’t necessarily indicate there is viable virus present in the respiratory tract. So in general, I think it is safe to go back to work, but a positive test in a situation like that can be very difficult to interpret because we think it probably doesn’t reflect infectivity, but we don’t know for sure.”
 

Do we have an adequate supply of tests in the United States?

The CDC has addressed supply concerns by broadening the number of PCR platforms that can be used to run COVID-19 analyses, Dr. Butler said. Expansion of these platforms has been one way the government is furthering testing options and enabling consumer labs and academic centers to contribute to testing.

When can people who test positive go back to work?

The CDC is still researching that question and reviewing the data, Dr. Butler said. The current recommendation is that a patient who tests positive is considered clear to return to work after two negative tests at least 24 hours apart, following the resolution of symptoms. The CDC has not yet made an official recommendation on an exact time frame, but the CDC is considering a 14-day minimum of quarantine.

“The one caveat I’ll add is that someone who is a health care worker, even if they have resolved symptoms, it’s still a good idea to wear a surgical mask [when they return to work], just as an extra precaution.”
 

What do we know about immunity? Can patients get reinfected?

Long-term immunity after exposure and infection is virtually unknown, Dr. Butler said. Investigators know those with COVID-19 have an antibody response, but whether that is protective or not, is unclear. In regard to older coronaviruses, such as those that cause colds, patients generally develop an antibody response and may have a period of immunity, but that immunity eventually wanes and reinfection can occur.

What is the latest on therapies?

A number of trials are underway in China and in the United States to test possible therapies for COVID-19, Dr. Butler said. One of the candidate drugs is the broad spectrum antiviral drug remdesivir, which was developed for the treatment of the Ebola virus. Additionally, the National Institutes of Health is studying the potential for monoclonal antibodies to treat COVID-19.

“Of course these are drugs not yet FDA approved,” he said. “We all want to have them in our toolbox as soon as possible, but we want to make sure these drugs are going to benefit and not harm, and that they really do have the utility that we hope for.”
 

Is there specific guidance for healthcare workers about COVID-19?

Health care workers have a much higher likelihood of being exposed or exposing others who are at high risk of severe infection, Dr. Butler said. That’s why, if a health care worker becomes infected and recovers, it’s still important to take extra precautions when going back to work, such as wearing a mask.

“These are recommendations that are in-draft,” he said. “I want to be clear, I’m floating concepts out there that people can consider. ... I recognize as a former infection control medical director at a hospital that sometimes you have to adapt those guidelines based on your local conditions.”

[email protected]

With new developments daily and lingering uncertainty about COVID-19, questions about testing and treatment for the coronavirus are at the forefront.

To address these top questions, Jay C. Butler, MD, deputy director for infectious diseases at the Centers for Disease Control and Prevention, sat down with JAMA editor Howard Bauchner, MD, to discuss the latest data on COVID-19 and to outline updated guidance from the agency. The following question-and-answer session was part of a live stream interview hosted by JAMA on March 16, 2020. The questions have been edited for length and clarity.
 

What test is being used to identify COVID-19?

In the United States, the most common and widely available test is the RT-polymerase chain reaction (rRT-PCR), which over the past few weeks has become available at public health labs across the country, Dr. Butler said during the JAMA interview. Capacity for the test is now possible in all 50 states and in Washington, D.C.

“More recently, there’s been a number of commercial labs that have come online to be able to do the testing,” Dr. Butler said. “Additionally, a number of academic centers are now able to run [Food and Drug Administration]–approved testing using slightly different PCR platforms.”
 

How accurate is the test?

Dr. Butler called PCR the “gold standard,” for testing COVID-19, and said it’s safe to say the test’s likelihood of identifying infection or past infection is extremely high. However, data on test sensitivity is limited.

“This may be frustrating to those of us who really like to know specifics of how to interpret the test results, but it’s important to keep in mind, we’re talking about a virus that we didn’t know existed 3 months ago,” he said.
 

At what point does a person with coronavirus test positive?

When exactly a test becomes positive is an unknown, Dr. Butler said. The assumption is that a patient who tests positive is more likely to be infectious, and data suggest the level of infectiousness is greatest after the onset of symptoms.

“There is at least some anecdotal reports that suggest that transmission could occur before onset of symptoms, but the data is still very limited,” he said. “Of course that has big implications in terms of how well we can really slow the spread of the virus.”
 

Who should get tested?

Dr. Butler said the focus should be individuals who are symptomatic with evidence of respiratory tract infection. People who are concerned about the virus and want a test are not the target.

“It’s important when talking to patients to help them to understand, this is different than a test for HIV or hepatitis C, where much of the message is: ‘Please get tested.’ ” he said. “This a situation where we’re trying to diagnose an acute infection. We do have a resource that may become limited again as some of the equipment required for running the test or collecting the specimen may come into short supply, so we want to focus on those people who are symptomatic and particularly on people who may be at higher risk of more severe illness.”
 

If a previously infected patient tests negative, can they still shed virus?

The CDC is currently analyzing how a negative PCR test relates to viral load, according to Dr. Butler. He added there have been situations in which a patient has twice tested negative for the virus, but a third swab resulted in a weakly positive result.

“It’s not clear if those are people who are actually infectious,” he said. “The PCR is detecting viral RNA, it doesn’t necessarily indicate there is viable virus present in the respiratory tract. So in general, I think it is safe to go back to work, but a positive test in a situation like that can be very difficult to interpret because we think it probably doesn’t reflect infectivity, but we don’t know for sure.”
 

Do we have an adequate supply of tests in the United States?

The CDC has addressed supply concerns by broadening the number of PCR platforms that can be used to run COVID-19 analyses, Dr. Butler said. Expansion of these platforms has been one way the government is furthering testing options and enabling consumer labs and academic centers to contribute to testing.

When can people who test positive go back to work?

The CDC is still researching that question and reviewing the data, Dr. Butler said. The current recommendation is that a patient who tests positive is considered clear to return to work after two negative tests at least 24 hours apart, following the resolution of symptoms. The CDC has not yet made an official recommendation on an exact time frame, but the CDC is considering a 14-day minimum of quarantine.

“The one caveat I’ll add is that someone who is a health care worker, even if they have resolved symptoms, it’s still a good idea to wear a surgical mask [when they return to work], just as an extra precaution.”
 

What do we know about immunity? Can patients get reinfected?

Long-term immunity after exposure and infection is virtually unknown, Dr. Butler said. Investigators know those with COVID-19 have an antibody response, but whether that is protective or not, is unclear. In regard to older coronaviruses, such as those that cause colds, patients generally develop an antibody response and may have a period of immunity, but that immunity eventually wanes and reinfection can occur.

What is the latest on therapies?

A number of trials are underway in China and in the United States to test possible therapies for COVID-19, Dr. Butler said. One of the candidate drugs is the broad spectrum antiviral drug remdesivir, which was developed for the treatment of the Ebola virus. Additionally, the National Institutes of Health is studying the potential for monoclonal antibodies to treat COVID-19.

“Of course these are drugs not yet FDA approved,” he said. “We all want to have them in our toolbox as soon as possible, but we want to make sure these drugs are going to benefit and not harm, and that they really do have the utility that we hope for.”
 

Is there specific guidance for healthcare workers about COVID-19?

Health care workers have a much higher likelihood of being exposed or exposing others who are at high risk of severe infection, Dr. Butler said. That’s why, if a health care worker becomes infected and recovers, it’s still important to take extra precautions when going back to work, such as wearing a mask.

“These are recommendations that are in-draft,” he said. “I want to be clear, I’m floating concepts out there that people can consider. ... I recognize as a former infection control medical director at a hospital that sometimes you have to adapt those guidelines based on your local conditions.”

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President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

[email protected]

President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

[email protected]

President Donald Trump has advised state governors not to wait on the federal government when it comes to ensuring readiness for a surge in patients from the COVID-19 outbreak.

Courtesy CDC

“If they are able to get ventilators, respirators, if they are able to get certain things without having to go through the longer process of federal government,” they should order on their own and bypass the federal government ordering system, the president stated during a March 16 press briefing.

That being said, he noted that the federal government is “ordering tremendous numbers of ventilators, respirators, [and] masks,” although he could not give a specific number on how much has been ordered or how many has already been stockpiled.

“It is always going to be faster if they can get them directly, if they need them, and I have given them authorization to order directly,” President Trump said.

The comments came as the White House revised recommendations on gatherings. The new guidelines now limit gatherings to no more than 10 people. Officials are further advising Americans to self-quarantine for 2 weeks if they are sick, if someone in their house is sick, or if someone in their house has tested positive for COVID-19.

Additionally, the White House called on Americans to limit discretionary travel and to avoid eating and drinking in restaurants, bars, and food courts during the next 15 days, even if they are feeling healthy and are asymptomatic.

“With several weeks of focused action, we can turn the corner and turn it quickly,” the president said.

In terms of testing, the Food and Drug Administration has granted emergency use authorization to two commercial diagnostic tests: Thermo Fisher for its TaqPath COVID-19 Combo Kit and Roche for its cobas SARS-CoV-2 test. White House officials said up to 1 million tests will be available this week, with 2 million next week.

The president also announced that phase 1 testing of a vaccine has begun. The test involves more than 40 healthy volunteers in the Seattle area who will receive three shots over the trial period. Phase 1 testing is generally conducted to determine safety of a new therapeutic.

[email protected]

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The European Society of Cardiology (ESC) has issued a statement urging physicians and patients to continue treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), in light of a newly described theory that those agents could increase the risk of developing COVID-19 and/or worsen its severity.

The concern arises from the observation that the new coronavirus SARS-CoV-2 causing COVID-19 binds to angiotensin-converting enzyme 2 (ACE2) to infect cells, and both ACE inhibitors and ARBs increase ACE2 levels.

This mechanism has been theorized as a possible risk factor for facilitating the acquisition of COVID-19 infection and worsening its severity. However, paradoxically, it has also been hypothesized to protect against acute lung injury from the disease.

Meanwhile, a Lancet Respiratory Medicine article was published March 11 entitled, “Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection?”

“We ... hypothesize that diabetes and hypertension treatment with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19,” said the authors.

This prompted some media coverage in the United Kingdom and “social media-related amplification,” leading to concern and, in some cases, discontinuation of the drugs by patients.

But on March 13, the ESC Council on Hypertension dismissed the concerns as entirely speculative, in a statement posted to the ESC website.

It said that the council “strongly recommend that physicians and patients should continue treatment with their usual antihypertensive therapy because there is no clinical or scientific evidence to suggest that treatment with ACE inhibitors or ARBs should be discontinued because of the COVID-19 infection.”

The statement, signed by Council Chair Professor Giovanni de Simone, MD, on behalf of the nucleus members, also says that in regard to the theorized protective effect against serious lung complications in individuals with COVID-19, the data come only from animal, and not human, studies.

“Speculation about the safety of ACE-inhibitor or ARB treatment in relation to COVID-19 does not have a sound scientific basis or evidence to support it,” the ESC panel concludes.

This article first appeared on Medscape.com.