Infectious Diseases

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

Skin manifestations were observed in about one-fifth of a group of patients with COVID-19 in the Alessandro Manzoni Hospital in Lecco, in northern Italy.

Courtesy of Dr. Randy Jacobs

Dermatologists there were pulled from their usual duty to help with the pandemic and looked at what was going on with the skin in 148 COVID-19 inpatients. They excluded 60 who had started new drugs within 15 days to rule out acute drug reactions, then reported what they saw (J Eur Acad Dermatol Venereol. 2020 Mar 26. doi: 10.1111/jdv.16387).

Of the 88 COVID-19 patients, 20.5% developed skin manifestations. Eight of the 18 (44%) had skin eruptions at symptom onset, and the rest after hospitalization. Fourteen (78%) had red rashes, three had widespread urticaria, and one had chickenpox-like vesicles. The most commonly affected area was the trunk. Itching was mild or absent, and lesions usually healed up in a few days. Most importantly, skin manifestations did not correlate with disease severity.

These skin manifestations “are similar to cutaneous involvement occurring during common viral infections,” said the author of the report, Sebastiano Recalcati, MD, a dermatologist at Alessandro Manzoni Hospital.

COVID-19 skin manifestations can cloud the diagnosis, according to the authors of another report from Thailand, where the first case of COVID-19 outside of China was reported.

They described a case of a COVID-19 infection in a Bangkok hospital that masqueraded as dengue fever. A person there presented with only a skin rash, petechiae, and a low platelet count, and was diagnosed with Dengue because that’s exactly what it looked like, the authors wrote (J Am Acad Dermatol. 2020 Mar 22. pii: S0190-9622[20]30454-0. doi: 10.1016/j.jaad.2020.03.036).

The correct diagnosis, COVID-19, was made at a tertiary care center after the patient was admitted with respiratory problems.

“There is a possibility that a COVID-19 patient might initially present with a skin rash that can be misdiagnosed as another common disease. ... The practitioner should recognize the possibility that the patient might have only a skin rash” at first, said the lead author of that report, Beuy Joob, PhD, of the Sanitation1 Medical Academic Center, Bangkok, and a coauthor.

There are similar reports in the United States, too. “Many have wondered if COVID-19 presents with any particular skin changes. The answer is yes,” said Randy Jacobs, MD, an assistant clinical professor of dermatology at the University of California, Riverside, who also has a private practice in southern California.

“COVID-19 can feature signs of small blood vessel occlusion. These can be petechiae or tiny bruises, and transient livedoid eruptions,” he said in an interview.

Dr. Jacobs had a 67-year-old patient who presented with a low fever, nasal congestion, postnasal drip, and a wet cough but no shortness of breath. It looked like a common cold. But a week later, the man had a nonpruritic blanching livedoid vascular eruption on his right anterior thigh, and blood in his urine, and he felt weak. The vascular eruption and bloody urine resolved in 24 hours, but the COVID-19 test came back positive and his cough became dry and hacking, and the weakness persisted. He’s in a hospital now and on oxygen, but not ventilated so far.

“Another dermatologist friend of mine also reported a similar transient COVID-19 unilateral livedoid eruption,” Dr. Jacobs said.

It suggests vaso-occlusion. Whether it’s neurogenic, microthrombotic, or immune complex mediated is unknown, but it’s “a skin finding that can help clinicians as they work up their patients with COVID-19 symptoms,” he noted.

Dr. Jacobs and the authors of the studies had no disclosures.

[email protected]

Skin manifestations were observed in about one-fifth of a group of patients with COVID-19 in the Alessandro Manzoni Hospital in Lecco, in northern Italy.

Courtesy of Dr. Randy Jacobs

Dermatologists there were pulled from their usual duty to help with the pandemic and looked at what was going on with the skin in 148 COVID-19 inpatients. They excluded 60 who had started new drugs within 15 days to rule out acute drug reactions, then reported what they saw (J Eur Acad Dermatol Venereol. 2020 Mar 26. doi: 10.1111/jdv.16387).

Of the 88 COVID-19 patients, 20.5% developed skin manifestations. Eight of the 18 (44%) had skin eruptions at symptom onset, and the rest after hospitalization. Fourteen (78%) had red rashes, three had widespread urticaria, and one had chickenpox-like vesicles. The most commonly affected area was the trunk. Itching was mild or absent, and lesions usually healed up in a few days. Most importantly, skin manifestations did not correlate with disease severity.

These skin manifestations “are similar to cutaneous involvement occurring during common viral infections,” said the author of the report, Sebastiano Recalcati, MD, a dermatologist at Alessandro Manzoni Hospital.

COVID-19 skin manifestations can cloud the diagnosis, according to the authors of another report from Thailand, where the first case of COVID-19 outside of China was reported.

They described a case of a COVID-19 infection in a Bangkok hospital that masqueraded as dengue fever. A person there presented with only a skin rash, petechiae, and a low platelet count, and was diagnosed with Dengue because that’s exactly what it looked like, the authors wrote (J Am Acad Dermatol. 2020 Mar 22. pii: S0190-9622[20]30454-0. doi: 10.1016/j.jaad.2020.03.036).

The correct diagnosis, COVID-19, was made at a tertiary care center after the patient was admitted with respiratory problems.

“There is a possibility that a COVID-19 patient might initially present with a skin rash that can be misdiagnosed as another common disease. ... The practitioner should recognize the possibility that the patient might have only a skin rash” at first, said the lead author of that report, Beuy Joob, PhD, of the Sanitation1 Medical Academic Center, Bangkok, and a coauthor.

There are similar reports in the United States, too. “Many have wondered if COVID-19 presents with any particular skin changes. The answer is yes,” said Randy Jacobs, MD, an assistant clinical professor of dermatology at the University of California, Riverside, who also has a private practice in southern California.

“COVID-19 can feature signs of small blood vessel occlusion. These can be petechiae or tiny bruises, and transient livedoid eruptions,” he said in an interview.

Dr. Jacobs had a 67-year-old patient who presented with a low fever, nasal congestion, postnasal drip, and a wet cough but no shortness of breath. It looked like a common cold. But a week later, the man had a nonpruritic blanching livedoid vascular eruption on his right anterior thigh, and blood in his urine, and he felt weak. The vascular eruption and bloody urine resolved in 24 hours, but the COVID-19 test came back positive and his cough became dry and hacking, and the weakness persisted. He’s in a hospital now and on oxygen, but not ventilated so far.

“Another dermatologist friend of mine also reported a similar transient COVID-19 unilateral livedoid eruption,” Dr. Jacobs said.

It suggests vaso-occlusion. Whether it’s neurogenic, microthrombotic, or immune complex mediated is unknown, but it’s “a skin finding that can help clinicians as they work up their patients with COVID-19 symptoms,” he noted.

Dr. Jacobs and the authors of the studies had no disclosures.

[email protected]

Skin manifestations were observed in about one-fifth of a group of patients with COVID-19 in the Alessandro Manzoni Hospital in Lecco, in northern Italy.

Courtesy of Dr. Randy Jacobs

Dermatologists there were pulled from their usual duty to help with the pandemic and looked at what was going on with the skin in 148 COVID-19 inpatients. They excluded 60 who had started new drugs within 15 days to rule out acute drug reactions, then reported what they saw (J Eur Acad Dermatol Venereol. 2020 Mar 26. doi: 10.1111/jdv.16387).

Of the 88 COVID-19 patients, 20.5% developed skin manifestations. Eight of the 18 (44%) had skin eruptions at symptom onset, and the rest after hospitalization. Fourteen (78%) had red rashes, three had widespread urticaria, and one had chickenpox-like vesicles. The most commonly affected area was the trunk. Itching was mild or absent, and lesions usually healed up in a few days. Most importantly, skin manifestations did not correlate with disease severity.

These skin manifestations “are similar to cutaneous involvement occurring during common viral infections,” said the author of the report, Sebastiano Recalcati, MD, a dermatologist at Alessandro Manzoni Hospital.

COVID-19 skin manifestations can cloud the diagnosis, according to the authors of another report from Thailand, where the first case of COVID-19 outside of China was reported.

They described a case of a COVID-19 infection in a Bangkok hospital that masqueraded as dengue fever. A person there presented with only a skin rash, petechiae, and a low platelet count, and was diagnosed with Dengue because that’s exactly what it looked like, the authors wrote (J Am Acad Dermatol. 2020 Mar 22. pii: S0190-9622[20]30454-0. doi: 10.1016/j.jaad.2020.03.036).

The correct diagnosis, COVID-19, was made at a tertiary care center after the patient was admitted with respiratory problems.

“There is a possibility that a COVID-19 patient might initially present with a skin rash that can be misdiagnosed as another common disease. ... The practitioner should recognize the possibility that the patient might have only a skin rash” at first, said the lead author of that report, Beuy Joob, PhD, of the Sanitation1 Medical Academic Center, Bangkok, and a coauthor.

There are similar reports in the United States, too. “Many have wondered if COVID-19 presents with any particular skin changes. The answer is yes,” said Randy Jacobs, MD, an assistant clinical professor of dermatology at the University of California, Riverside, who also has a private practice in southern California.

“COVID-19 can feature signs of small blood vessel occlusion. These can be petechiae or tiny bruises, and transient livedoid eruptions,” he said in an interview.

Dr. Jacobs had a 67-year-old patient who presented with a low fever, nasal congestion, postnasal drip, and a wet cough but no shortness of breath. It looked like a common cold. But a week later, the man had a nonpruritic blanching livedoid vascular eruption on his right anterior thigh, and blood in his urine, and he felt weak. The vascular eruption and bloody urine resolved in 24 hours, but the COVID-19 test came back positive and his cough became dry and hacking, and the weakness persisted. He’s in a hospital now and on oxygen, but not ventilated so far.

“Another dermatologist friend of mine also reported a similar transient COVID-19 unilateral livedoid eruption,” Dr. Jacobs said.

It suggests vaso-occlusion. Whether it’s neurogenic, microthrombotic, or immune complex mediated is unknown, but it’s “a skin finding that can help clinicians as they work up their patients with COVID-19 symptoms,” he noted.

Dr. Jacobs and the authors of the studies had no disclosures.

[email protected]

Asymptomatic transmission is the most likely explanation for 6.4% of the locally acquired COVID-19 infections in Singapore, based on clinical and epidemiologic data for all cases reported in the country by March 16.

As of that date, there had been 243 cases of COVID-19, of which 157 were locally acquired. Among those 157 were 10 cases (6.4%) that involved probable presymptomatic transmission, Wycliffe E. Wei, MPH, and associates said April 1 in the Morbidity and Mortality Weekly Report.

They defined presymptomatic transmission “as the transmission of SARS-CoV-2 from an infected person (source patient) to a secondary patient before the source patient developed symptoms, as ascertained by exposure and symptom onset dates, with no evidence that the secondary patient had been exposed to anyone else with COVID-19.”

Investigation of all 243 cases in Singapore identified seven clusters, each involving two to five patients, as sources of presymptomatic transmission. In four of the clusters, the “exposure occurred 1-3 days before the source patient developed symptoms,” said Mr. Wei of the Singapore Ministry of Health and associates.

These findings, along with evidence from Chinese studies – one of which reported presymptomatic transmission in 12.6% of cases – support “the likelihood that viral shedding can occur in the absence of symptoms and before symptom onset,” they said.

[email protected]

SOURCE: Wei WE et al. MMWR. 2020 Apr 1;69(ePub):1-5. doi: 10.15585/mmwr.mm6914e1.

Asymptomatic transmission is the most likely explanation for 6.4% of the locally acquired COVID-19 infections in Singapore, based on clinical and epidemiologic data for all cases reported in the country by March 16.

As of that date, there had been 243 cases of COVID-19, of which 157 were locally acquired. Among those 157 were 10 cases (6.4%) that involved probable presymptomatic transmission, Wycliffe E. Wei, MPH, and associates said April 1 in the Morbidity and Mortality Weekly Report.

They defined presymptomatic transmission “as the transmission of SARS-CoV-2 from an infected person (source patient) to a secondary patient before the source patient developed symptoms, as ascertained by exposure and symptom onset dates, with no evidence that the secondary patient had been exposed to anyone else with COVID-19.”

Investigation of all 243 cases in Singapore identified seven clusters, each involving two to five patients, as sources of presymptomatic transmission. In four of the clusters, the “exposure occurred 1-3 days before the source patient developed symptoms,” said Mr. Wei of the Singapore Ministry of Health and associates.

These findings, along with evidence from Chinese studies – one of which reported presymptomatic transmission in 12.6% of cases – support “the likelihood that viral shedding can occur in the absence of symptoms and before symptom onset,” they said.

[email protected]

SOURCE: Wei WE et al. MMWR. 2020 Apr 1;69(ePub):1-5. doi: 10.15585/mmwr.mm6914e1.

Asymptomatic transmission is the most likely explanation for 6.4% of the locally acquired COVID-19 infections in Singapore, based on clinical and epidemiologic data for all cases reported in the country by March 16.

As of that date, there had been 243 cases of COVID-19, of which 157 were locally acquired. Among those 157 were 10 cases (6.4%) that involved probable presymptomatic transmission, Wycliffe E. Wei, MPH, and associates said April 1 in the Morbidity and Mortality Weekly Report.

They defined presymptomatic transmission “as the transmission of SARS-CoV-2 from an infected person (source patient) to a secondary patient before the source patient developed symptoms, as ascertained by exposure and symptom onset dates, with no evidence that the secondary patient had been exposed to anyone else with COVID-19.”

Investigation of all 243 cases in Singapore identified seven clusters, each involving two to five patients, as sources of presymptomatic transmission. In four of the clusters, the “exposure occurred 1-3 days before the source patient developed symptoms,” said Mr. Wei of the Singapore Ministry of Health and associates.

These findings, along with evidence from Chinese studies – one of which reported presymptomatic transmission in 12.6% of cases – support “the likelihood that viral shedding can occur in the absence of symptoms and before symptom onset,” they said.

[email protected]

SOURCE: Wei WE et al. MMWR. 2020 Apr 1;69(ePub):1-5. doi: 10.15585/mmwr.mm6914e1.

In the wake of the 2012 shooting at Sandy Hook Elementary, in Newtown, Conn., after 20 children and seven adults were murdered, American gun sales surged on fears of new restrictions.

Bytmonas/ThinkStock

In the ensuing months, 20 more children and 40 more adults died from unintentional shootings believed to be tied to that surge in gun purchases.¹ More recently, American gun sales surged in response to the COVID-19 pandemic with heated legal battles brewing over whether gun sales are essential.^2,3 The results of this surge in sales are yet to fully manifest, but I would like to discuss several risks.

The public health risks of firearm access are well established: Nearly every measure of harm, from suicide to negligent injury and death to homicide to shootings of police, increase along with access to firearms.⁴ That firearms in the home are associated with greater likelihoods of suicide, negligent injury and death, and intrafamilial homicide has been recognized for decades as has the substantially heightened risk in the immediate period after a firearm is brought into the home.^5,6 Defensive gun use is rare despite this being the nominal reason for firearm ownership among many.⁷ Even prior to recent events, there had been concerns of increased unsafe carrying and handling of firearms.⁸ It seems reasonable to expect such trends not to be diminished by recent events.

Added to this are several stressors, which one can reasonably expect to be associated with increased risks for unsafe use. There are new, broad social stressors from fear and uncertainty about COVID-19. Unemployment rates have skyrocketed, clinical care has been disrupted, and basic necessities have become scant. Children are home from school, unable to play with friends and unable to access mental health services as easily as before; risks of negligent and suicidal injuries and death may ensue. Couples and families are isolated in homes together for longer periods and with fewer avenues for relief; previously peaceful homes may see conflicts increase and homes with abuse have now trapped victims with their assailants. Social isolation is difficult for any person and may be even more traumatic for people with underlying vulnerabilities, including mental illness. The risks of being isolated in a home – struggling with worsening symptoms – with ready access to a firearm are self-evident.

For mental health professionals in our current situation, I would like to offer several practical ways we can intervene with patients and clients who might own firearms.

• Consider reassessing for firearm access. Patients may be in new homes, or there may be new firearms in their homes. Use gentle assumptions and focus on home access over personal access to elicit the most true, positive answers, for example: “I understand there have been a lot of changes recently; how many guns are in the home now?”
• Reinforce safer storage practices. Simple measures, such as storing ammunition separately and using trigger locks or safes, can make a substantial difference in injury risks.
• Do not forget aging clients; suicide risk increases with age, and there may be substantial risks among the geriatric population for suicide and murder-suicide. If using telepsychiatry, realize that the abuser might be in the home or within earshot of any clinical encounter, and this might put the client at heightened risk, during and after telesessions.
• Highlight access to local and national resources, including the Disaster Distress Hotline (800-985-5990) and the National Suicide Prevention Lifeline (800-273-TALK). Promote both numbers, and note that some people may be more comfortable reaching out for help for “distress” than for “suicide.”

References

1. Levine PB and McKnight R. Science. 2017 Dec 8;358(6368):1324-8.

2. Levin D. “Coronavirus and firearms: Are gun shops essential businesses?” The New York Times. 2020 Mar 25.

3. Robertson L. “Neither hurricanes nor 9/11 caused as big a surge in gun sales as coronavirus.” Miami Herald. 2020 Mar 25.

4. Moyer MW. Scientific American. 2017 Oct;317(4):54-63.

5. Kellermann AL et al. J Trauma. 1998 Aug;45(2):263-7.

6. Wintemute GJ et al. New Engl J Med. 1999 Nov 18;341(21):1583-9.

7. Firearm Justifiable Homicides and Non-Fatal Self-Defense Gun Use: An Analysis of Federal Bureau of Investigation and National Crime Victimization Survey Data. Washington: Violence Policy Center; 2019 Jul.

8. Towers S et al. bioRxiv. 2019 Apr 18;613687.
 

Dr. Rozel is the medical director of resolve Crisis Services at UPMC Western Psychiatric Hospital and president of the American Association for Emergency Psychiatry. He also is associate professor of psychiatry and an adjunct professor of law at the University of Pittsburgh. He has no conflicts of interest but has worked for a gun dealer to teach sales staff how to recognize people in crisis (rather than sell a gun).

In the wake of the 2012 shooting at Sandy Hook Elementary, in Newtown, Conn., after 20 children and seven adults were murdered, American gun sales surged on fears of new restrictions.

Bytmonas/ThinkStock

In the ensuing months, 20 more children and 40 more adults died from unintentional shootings believed to be tied to that surge in gun purchases.¹ More recently, American gun sales surged in response to the COVID-19 pandemic with heated legal battles brewing over whether gun sales are essential.^2,3 The results of this surge in sales are yet to fully manifest, but I would like to discuss several risks.

The public health risks of firearm access are well established: Nearly every measure of harm, from suicide to negligent injury and death to homicide to shootings of police, increase along with access to firearms.⁴ That firearms in the home are associated with greater likelihoods of suicide, negligent injury and death, and intrafamilial homicide has been recognized for decades as has the substantially heightened risk in the immediate period after a firearm is brought into the home.^5,6 Defensive gun use is rare despite this being the nominal reason for firearm ownership among many.⁷ Even prior to recent events, there had been concerns of increased unsafe carrying and handling of firearms.⁸ It seems reasonable to expect such trends not to be diminished by recent events.

Added to this are several stressors, which one can reasonably expect to be associated with increased risks for unsafe use. There are new, broad social stressors from fear and uncertainty about COVID-19. Unemployment rates have skyrocketed, clinical care has been disrupted, and basic necessities have become scant. Children are home from school, unable to play with friends and unable to access mental health services as easily as before; risks of negligent and suicidal injuries and death may ensue. Couples and families are isolated in homes together for longer periods and with fewer avenues for relief; previously peaceful homes may see conflicts increase and homes with abuse have now trapped victims with their assailants. Social isolation is difficult for any person and may be even more traumatic for people with underlying vulnerabilities, including mental illness. The risks of being isolated in a home – struggling with worsening symptoms – with ready access to a firearm are self-evident.

For mental health professionals in our current situation, I would like to offer several practical ways we can intervene with patients and clients who might own firearms.

• Consider reassessing for firearm access. Patients may be in new homes, or there may be new firearms in their homes. Use gentle assumptions and focus on home access over personal access to elicit the most true, positive answers, for example: “I understand there have been a lot of changes recently; how many guns are in the home now?”
• Reinforce safer storage practices. Simple measures, such as storing ammunition separately and using trigger locks or safes, can make a substantial difference in injury risks.
• Do not forget aging clients; suicide risk increases with age, and there may be substantial risks among the geriatric population for suicide and murder-suicide. If using telepsychiatry, realize that the abuser might be in the home or within earshot of any clinical encounter, and this might put the client at heightened risk, during and after telesessions.
• Highlight access to local and national resources, including the Disaster Distress Hotline (800-985-5990) and the National Suicide Prevention Lifeline (800-273-TALK). Promote both numbers, and note that some people may be more comfortable reaching out for help for “distress” than for “suicide.”

References

1. Levine PB and McKnight R. Science. 2017 Dec 8;358(6368):1324-8.

2. Levin D. “Coronavirus and firearms: Are gun shops essential businesses?” The New York Times. 2020 Mar 25.

3. Robertson L. “Neither hurricanes nor 9/11 caused as big a surge in gun sales as coronavirus.” Miami Herald. 2020 Mar 25.

4. Moyer MW. Scientific American. 2017 Oct;317(4):54-63.

5. Kellermann AL et al. J Trauma. 1998 Aug;45(2):263-7.

6. Wintemute GJ et al. New Engl J Med. 1999 Nov 18;341(21):1583-9.

7. Firearm Justifiable Homicides and Non-Fatal Self-Defense Gun Use: An Analysis of Federal Bureau of Investigation and National Crime Victimization Survey Data. Washington: Violence Policy Center; 2019 Jul.

8. Towers S et al. bioRxiv. 2019 Apr 18;613687.
 

Dr. Rozel is the medical director of resolve Crisis Services at UPMC Western Psychiatric Hospital and president of the American Association for Emergency Psychiatry. He also is associate professor of psychiatry and an adjunct professor of law at the University of Pittsburgh. He has no conflicts of interest but has worked for a gun dealer to teach sales staff how to recognize people in crisis (rather than sell a gun).

In the wake of the 2012 shooting at Sandy Hook Elementary, in Newtown, Conn., after 20 children and seven adults were murdered, American gun sales surged on fears of new restrictions.

Bytmonas/ThinkStock

In the ensuing months, 20 more children and 40 more adults died from unintentional shootings believed to be tied to that surge in gun purchases.¹ More recently, American gun sales surged in response to the COVID-19 pandemic with heated legal battles brewing over whether gun sales are essential.^2,3 The results of this surge in sales are yet to fully manifest, but I would like to discuss several risks.

The public health risks of firearm access are well established: Nearly every measure of harm, from suicide to negligent injury and death to homicide to shootings of police, increase along with access to firearms.⁴ That firearms in the home are associated with greater likelihoods of suicide, negligent injury and death, and intrafamilial homicide has been recognized for decades as has the substantially heightened risk in the immediate period after a firearm is brought into the home.^5,6 Defensive gun use is rare despite this being the nominal reason for firearm ownership among many.⁷ Even prior to recent events, there had been concerns of increased unsafe carrying and handling of firearms.⁸ It seems reasonable to expect such trends not to be diminished by recent events.

Added to this are several stressors, which one can reasonably expect to be associated with increased risks for unsafe use. There are new, broad social stressors from fear and uncertainty about COVID-19. Unemployment rates have skyrocketed, clinical care has been disrupted, and basic necessities have become scant. Children are home from school, unable to play with friends and unable to access mental health services as easily as before; risks of negligent and suicidal injuries and death may ensue. Couples and families are isolated in homes together for longer periods and with fewer avenues for relief; previously peaceful homes may see conflicts increase and homes with abuse have now trapped victims with their assailants. Social isolation is difficult for any person and may be even more traumatic for people with underlying vulnerabilities, including mental illness. The risks of being isolated in a home – struggling with worsening symptoms – with ready access to a firearm are self-evident.

For mental health professionals in our current situation, I would like to offer several practical ways we can intervene with patients and clients who might own firearms.

• Consider reassessing for firearm access. Patients may be in new homes, or there may be new firearms in their homes. Use gentle assumptions and focus on home access over personal access to elicit the most true, positive answers, for example: “I understand there have been a lot of changes recently; how many guns are in the home now?”
• Reinforce safer storage practices. Simple measures, such as storing ammunition separately and using trigger locks or safes, can make a substantial difference in injury risks.
• Do not forget aging clients; suicide risk increases with age, and there may be substantial risks among the geriatric population for suicide and murder-suicide. If using telepsychiatry, realize that the abuser might be in the home or within earshot of any clinical encounter, and this might put the client at heightened risk, during and after telesessions.
• Highlight access to local and national resources, including the Disaster Distress Hotline (800-985-5990) and the National Suicide Prevention Lifeline (800-273-TALK). Promote both numbers, and note that some people may be more comfortable reaching out for help for “distress” than for “suicide.”

References

1. Levine PB and McKnight R. Science. 2017 Dec 8;358(6368):1324-8.

2. Levin D. “Coronavirus and firearms: Are gun shops essential businesses?” The New York Times. 2020 Mar 25.

3. Robertson L. “Neither hurricanes nor 9/11 caused as big a surge in gun sales as coronavirus.” Miami Herald. 2020 Mar 25.

4. Moyer MW. Scientific American. 2017 Oct;317(4):54-63.

5. Kellermann AL et al. J Trauma. 1998 Aug;45(2):263-7.

6. Wintemute GJ et al. New Engl J Med. 1999 Nov 18;341(21):1583-9.

7. Firearm Justifiable Homicides and Non-Fatal Self-Defense Gun Use: An Analysis of Federal Bureau of Investigation and National Crime Victimization Survey Data. Washington: Violence Policy Center; 2019 Jul.

8. Towers S et al. bioRxiv. 2019 Apr 18;613687.
 

Dr. Rozel is the medical director of resolve Crisis Services at UPMC Western Psychiatric Hospital and president of the American Association for Emergency Psychiatry. He also is associate professor of psychiatry and an adjunct professor of law at the University of Pittsburgh. He has no conflicts of interest but has worked for a gun dealer to teach sales staff how to recognize people in crisis (rather than sell a gun).

Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Updated April 2, 2020.

The commander of a US Navy aircraft carrier in the midst of a COVID-19 outbreak was swiftly fired by Acting Secretary of the Navy Thomas Modly following media coverage of the plight of more than 200 COVID-19 positive sailors on the USS Theodore Roosevelt.

In a statement released April 2, Modly announced the removal of Capt. Brett Crozier for writing a memo that was later leaked to the San Francisco Chronicle newspaper. According to Acting Secretary Modly, the memo was sent “outside the chain of command” and his action “made his Sailors, their families, and many in the public believe that his letter was the only reason help from our larger Navy family was forthcoming, which was hardly the case.”

On Monday, March 30, Capt. Crozier, commanding officer of the nuclear aircraft carrier USS Theodore Roosevelt, sent an urgent request for assistance to senior Navy officials: “[I]n combat we are willing to take certain risks that are not acceptable in peacetime. However, we are not at war, and therefore cannot allow a single Sailor to perish as a result of this pandemic unnecessarily. Decisive action is required now in order to comply with CDC and NAVADMIN 083/20 guidance and prevent tragic outcomes.”

Even as a number of cruise ships with ill and dying passengers were—are—waiting to be allowed to dock in Florida and elsewhere, the USS Theodore Roosevelt was also dealing with a COVID-19 outbreak onboard—and awaiting permission to let the crew of more than 4,000 on shore so they could quarantine safely.

Crozier pointed to “lessons learned” from the Diamond Princess—the only comparable situation at the time. He quoted from the abstract to an epidemiological research study: An index case on board the cruise ship was reported in late January; a month later, 619 of 3,700 passengers and crew had tested positive. Without any interventions, the abstract noted, between January 21st and February 19th an estimated 2,920 of the passengers would have been infected. Isolation and quarantine, it concluded, prevented 2,307 cases. Further, an early evacuation would have been associated with 76 infected persons.

The Diamond Princess, Crozier wrote, was able to more effectively isolate people due to a higher percentage of individual and compartmentalized accommodations. However, due to a warship’s “inherent limitations of space,” his crew could not comply with orders to practice social distancing. “With the exceptions of a handful of senior officer staterooms,” he wrote, “none of the berthing onboard a warship is appropriate for quarantine or isolation.” He also pointed to other obstacles: shared bathrooms, shared sleeping quarters, group mealtimes, and ladders and other surfaces touched and possibly contaminated as crew move around the ship.

Moreover, Crozier wrote, “The spread of the disease is ongoing and accelerating.” By Tuesday March 31st, nearly 1,300 sailors had been tested, and hundreds were testing negative, but 243 sailors had tested positive and 87 more were showing symptoms, according to the latest reports. So far, none are showing serious symptoms.

“If we do not act now, we are failing to take care of our most trusted asset—our sailors,” Capt Crozier wrote. At first, no one seemed to be listening, but after the Chronicle broke the story and it began circulating in the media—things changed. “I heard about the letter from Capt. Crozier [Tuesday] morning,” said Acting Secretary Modly in an interview with the Chronicle. “I know that our command organization has been aware of this for about 24 hours and we have been working actually the last 7 days to move those sailors off the ship and get them into accommodations in Guam. The problem is that Guam doesn’t have enough beds right now and we’re having to talk to the government there to see if we can get some hotel space, create tent-type facilities.”

He noted that the situation for the USS Theodore Roosevelt is “a little bit different and unique” in that it has aircraft and armaments on it, fire hazards, and “we have to run a nuclear power plant.” Crozier had proposed that approximately 10% of the crew remain on board to take care of the duties such as tending to the nuclear reactor.

As of April 1, the Navy plans to remove some 2,700 sailors to the hotel rooms government officials on Guam have secured for them. Secretary Modly made no mention of the care or treatment of infected sailors in his April 2nd statement, but offered this reassurance: "You can offer comfort to your fellow citizens who are struggling and fearful here at home by standing the watch, and working your way through this pandemic with courage and optimism and set the example for the nation. We have an obligation to ensure you have everything you need as fast as we can get it there, and you have my commitment that we will not let you down."

Greater prevalence of underlying health conditions such as diabetes and chronic lung disease was seen among nearly 7,200 Americans hospitalized with coronavirus disease 2019 (COVID-19), according to the Centers for Disease Control and Prevention.

Of the 122,653 laboratory-confirmed COVID-19 cases reported to the CDC as of March 28, the COVID-19 Response Team had access to data on the presence or absence of underlying health conditions and other recognized risk factors for severe outcomes from respiratory infections for 7,162 (5.8%) patients.

“Among these patients, higher percentages of patients with underlying conditions were admitted to the hospital and to an ICU than patients without reported underlying conditions. These results are consistent with findings from China and Italy,” Katherine Fleming-Dutra, MD, and associates said in the MMWR.

Individuals with underlying health conditions/risk factors made up 37.6% of all COVID-19 patients in the study but represented a majority of ICU (78%) and non-ICU (71%) hospital admissions. In contrast, 73% of COVID-19 patients who were not hospitalized had no underlying conditions, Dr. Fleming-Dutra and the CDC COVID-19 Response Team reported.

With a prevalence of 10.9%, diabetes mellitus was the most common condition reported among all COVID-19 patients, followed by chronic lung disease (9.2%) and cardiovascular disease (9.0%), the investigators said.

Another look at the data shows that 40.5% of those with underlying conditions were hospitalized, compared with 9.0% of the 4,470 COVID-19 patients without any risk factors.

“Strategies to protect all persons and especially those with underlying health conditions, including social distancing and handwashing, should be implemented by all communities and all persons to help slow the spread of COVID-19,” the response team wrote.

[email protected]

SOURCE: Fleming-Dutra K et al. MMWR. 2020 Mar 31;69 (early release):1-5.

Greater prevalence of underlying health conditions such as diabetes and chronic lung disease was seen among nearly 7,200 Americans hospitalized with coronavirus disease 2019 (COVID-19), according to the Centers for Disease Control and Prevention.

Of the 122,653 laboratory-confirmed COVID-19 cases reported to the CDC as of March 28, the COVID-19 Response Team had access to data on the presence or absence of underlying health conditions and other recognized risk factors for severe outcomes from respiratory infections for 7,162 (5.8%) patients.

“Among these patients, higher percentages of patients with underlying conditions were admitted to the hospital and to an ICU than patients without reported underlying conditions. These results are consistent with findings from China and Italy,” Katherine Fleming-Dutra, MD, and associates said in the MMWR.

Individuals with underlying health conditions/risk factors made up 37.6% of all COVID-19 patients in the study but represented a majority of ICU (78%) and non-ICU (71%) hospital admissions. In contrast, 73% of COVID-19 patients who were not hospitalized had no underlying conditions, Dr. Fleming-Dutra and the CDC COVID-19 Response Team reported.

With a prevalence of 10.9%, diabetes mellitus was the most common condition reported among all COVID-19 patients, followed by chronic lung disease (9.2%) and cardiovascular disease (9.0%), the investigators said.

Another look at the data shows that 40.5% of those with underlying conditions were hospitalized, compared with 9.0% of the 4,470 COVID-19 patients without any risk factors.

“Strategies to protect all persons and especially those with underlying health conditions, including social distancing and handwashing, should be implemented by all communities and all persons to help slow the spread of COVID-19,” the response team wrote.

[email protected]

SOURCE: Fleming-Dutra K et al. MMWR. 2020 Mar 31;69 (early release):1-5.

Greater prevalence of underlying health conditions such as diabetes and chronic lung disease was seen among nearly 7,200 Americans hospitalized with coronavirus disease 2019 (COVID-19), according to the Centers for Disease Control and Prevention.

Of the 122,653 laboratory-confirmed COVID-19 cases reported to the CDC as of March 28, the COVID-19 Response Team had access to data on the presence or absence of underlying health conditions and other recognized risk factors for severe outcomes from respiratory infections for 7,162 (5.8%) patients.

“Among these patients, higher percentages of patients with underlying conditions were admitted to the hospital and to an ICU than patients without reported underlying conditions. These results are consistent with findings from China and Italy,” Katherine Fleming-Dutra, MD, and associates said in the MMWR.

Individuals with underlying health conditions/risk factors made up 37.6% of all COVID-19 patients in the study but represented a majority of ICU (78%) and non-ICU (71%) hospital admissions. In contrast, 73% of COVID-19 patients who were not hospitalized had no underlying conditions, Dr. Fleming-Dutra and the CDC COVID-19 Response Team reported.

With a prevalence of 10.9%, diabetes mellitus was the most common condition reported among all COVID-19 patients, followed by chronic lung disease (9.2%) and cardiovascular disease (9.0%), the investigators said.

Another look at the data shows that 40.5% of those with underlying conditions were hospitalized, compared with 9.0% of the 4,470 COVID-19 patients without any risk factors.

“Strategies to protect all persons and especially those with underlying health conditions, including social distancing and handwashing, should be implemented by all communities and all persons to help slow the spread of COVID-19,” the response team wrote.

[email protected]

SOURCE: Fleming-Dutra K et al. MMWR. 2020 Mar 31;69 (early release):1-5.

The immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, raising the likelihood that the similarly behaving SARS-CoV-2 might provoke the same response, according to an online communication published in the Journal of Microbiology, Immunology and Infection.

Courtesy NIAID-RML

The authors cited a cohort study of convalescent SARS-CoV patients (56 cases, from the Beijing hospital of the Armed Forces Police, China) that showed that specific IgG antibodies and neutralizing antibodies were highly correlated, peaking at month 4 after the onset of disease and decreasing gradually thereafter.

This and other studies suggest that the immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, according to the authors.

However, of particular concern is the fact that only 11.8% of patients acquire specific SARS-CoV Abs in the early period after recovery at day 7, not reaching 100% until day 90, which highlights the importance of the detection of antibody titers for convalescent COVID-19 patients, according to the authors. “Otherwise, these patients with low titers of antibodies may not be efficient for the clearance of SARS-CoV-2.”

The authors also cited a recent study that showed how neutralizing antibody from a convalescent SARS patient could block the SARS-CoV-2 from entering into target cells in vitro, and suggested that previous experimental SARS-CoV vaccines and neutralizing antibodies could provide novel preventive and therapeutic options for COVID-19.

“These experiences from SARS-CoV are expected to have some implications for the treatment, management and surveillance of SARS-CoV-2 patients,” the authors concluded.

[email protected]

SOURCE: Lin Q et al. J Microbiol Immunol Infect. 2020 Mar 25. https://doi.org/10.1016/j.jmii.2020.03.015.

The immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, raising the likelihood that the similarly behaving SARS-CoV-2 might provoke the same response, according to an online communication published in the Journal of Microbiology, Immunology and Infection.

Courtesy NIAID-RML

The authors cited a cohort study of convalescent SARS-CoV patients (56 cases, from the Beijing hospital of the Armed Forces Police, China) that showed that specific IgG antibodies and neutralizing antibodies were highly correlated, peaking at month 4 after the onset of disease and decreasing gradually thereafter.

This and other studies suggest that the immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, according to the authors.

However, of particular concern is the fact that only 11.8% of patients acquire specific SARS-CoV Abs in the early period after recovery at day 7, not reaching 100% until day 90, which highlights the importance of the detection of antibody titers for convalescent COVID-19 patients, according to the authors. “Otherwise, these patients with low titers of antibodies may not be efficient for the clearance of SARS-CoV-2.”

The authors also cited a recent study that showed how neutralizing antibody from a convalescent SARS patient could block the SARS-CoV-2 from entering into target cells in vitro, and suggested that previous experimental SARS-CoV vaccines and neutralizing antibodies could provide novel preventive and therapeutic options for COVID-19.

“These experiences from SARS-CoV are expected to have some implications for the treatment, management and surveillance of SARS-CoV-2 patients,” the authors concluded.

[email protected]

SOURCE: Lin Q et al. J Microbiol Immunol Infect. 2020 Mar 25. https://doi.org/10.1016/j.jmii.2020.03.015.

The immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, raising the likelihood that the similarly behaving SARS-CoV-2 might provoke the same response, according to an online communication published in the Journal of Microbiology, Immunology and Infection.

Courtesy NIAID-RML

The authors cited a cohort study of convalescent SARS-CoV patients (56 cases, from the Beijing hospital of the Armed Forces Police, China) that showed that specific IgG antibodies and neutralizing antibodies were highly correlated, peaking at month 4 after the onset of disease and decreasing gradually thereafter.

This and other studies suggest that the immune responses of specific antibodies were maintained in more than 90% of recovered SARS-CoV patients for 2 years, according to the authors.

However, of particular concern is the fact that only 11.8% of patients acquire specific SARS-CoV Abs in the early period after recovery at day 7, not reaching 100% until day 90, which highlights the importance of the detection of antibody titers for convalescent COVID-19 patients, according to the authors. “Otherwise, these patients with low titers of antibodies may not be efficient for the clearance of SARS-CoV-2.”

The authors also cited a recent study that showed how neutralizing antibody from a convalescent SARS patient could block the SARS-CoV-2 from entering into target cells in vitro, and suggested that previous experimental SARS-CoV vaccines and neutralizing antibodies could provide novel preventive and therapeutic options for COVID-19.

“These experiences from SARS-CoV are expected to have some implications for the treatment, management and surveillance of SARS-CoV-2 patients,” the authors concluded.

[email protected]

SOURCE: Lin Q et al. J Microbiol Immunol Infect. 2020 Mar 25. https://doi.org/10.1016/j.jmii.2020.03.015.

A controversial study led by Didier Raoult, MD, PhD, on the combination of hydroxychloroquine and azithromycin in patients with COVID-19 was published March 20. The latest results from the same Marseille team, which involve 80 patients, were reported on March 27.

The investigators report a significant reduction in the viral load (83% patients had negative results on quantitative polymerase chain reaction testing at day 7, and 93% had negative results on day 8). There was a “clinical improvement compared to the natural progression.” One death occurred, and three patients were transferred to intensive care units.

If the data seem encouraging, the lack of a control arm in the study leaves clinicians perplexed, however.

Benjamin Davido, MD, an infectious disease specialist at Raymond-Poincaré Hospital in Garches, Paris, spoke in an interview about the implications of these new results.
 

What do you think about the new results presented by Prof. Raoult’s team? Do they confirm the effectiveness of hydroxychloroquine?

These results are complementary [to the original results] but don’t offer any new information or new statistical evidence. They are absolutely superimposable and say overall that, between 5 and 7 days [of treatment], very few patients shed the virus. But that is not the question that everyone is asking.

Even if we don’t necessarily have to conduct a randomized study, we should at least compare the treatment, either against another therapy – which could be hydroxychloroquine monotherapy, or just standard of care. It needed an authentic control arm.

To recruit 80 patients so quickly, the researchers probably took people with essentially ambulatory forms of the disease (there was a call for screening in the south of France) – therefore, by definition, less severe cases.

But to describe such a population of patients as going home and saying, “There were very few hospitalizations and it is going well,” does not in any way prove that the treatment reduces hospitalizations.
 

The argument for not having a control arm in this study was that it would be unethical. What do you think?

I agree with this argument when it comes to patients presenting with risk factors or who are starting to develop pneumonia.

But I don’t think this is the case at the beginning of the illness. Of course, you don’t want to wait to have severe disease or for the patient to be in intensive care to start treatment. In these cases, it is indeed very difficult to find a control arm.
 

In the ongoing Discovery trial, which involves more than 3,000 patients in Europe, including 800 in France, the patients have severe disease, and there are five treatment arms. Moreover, hydroxychloroquine is given without azithromycin. What do you think of this?

I think it’s a mistake. It will not answer the question of the effectiveness of hydroxychloroquine in COVID-19, especially as they’re not studying azithromycin in a situation where the compound seems necessary for the effectiveness of the treatment.

In addition, Discovery reinforces the notion of studying Kaletra [lopinavir/ritonavir, AbbVie] again, while Chinese researchers have shown that it does not work, the argument being that Kaletra was given too late (N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282). Therefore, if we make the same mistakes from a methodological point of view, we will end up with negative results.
 

What should have been done in the Marseille study?

The question is: Are there more or fewer hospitalizations when we treat a homogeneous population straight away?

The answer could be very clear, as a control already exists! They are the patients that flow into our hospitals every day – ironically, these 80 patients [in the latest results, presented March 27] could be among the 80% who had a form similar to nasopharyngitis and resolved.

In this illness, we know that there are 80% spontaneous recoveries and 20% so-called severe forms. Therefore, with 80 patients, we are very underpowered. The cohort is too small for a disease in which 80% of the evolution is benign.

It would take 1,000 patients, and then, even without a control arm, we would have an answer.

On March 26, Didier Raoult’s team also announced having already treated 700 patients with hydroxychloroquine, with only one death. Therefore, if this cohort increases significantly in Marseille and we see that, on the map, there are fewer issues with patient flow and saturation in Marseille and that there are fewer patients in intensive care, you will have to wonder about the effect of hydroxychloroquine.

We will find out very quickly. If it really works, and they treat all the patients presenting at Timone Hospital, we will soon have the answer. It will be a real-life study.
 

What are the other studies on hydroxychloroquine that could give us answers?

There was a Chinese study that did not show a difference in effectiveness between hydroxychloroquine and placebo, but that was, again, conducted in only around 20 patients (J Zhejiang Univ (Med Sci). 2020. doi: 10.3785/j.issn.1008-9292.2020.03.03). This cohort is too small and tells us nothing; it cannot show anything. We must wait for the results of larger trials being conducted in China.

It surprises me that, today, we still do not have Italian data on the use of chloroquine-type drugs ... perhaps because they have a care pathway that means there is no outpatient treatment and that they arrive already with severe disease. The Italian recommendations nevertheless indicate the use of hydroxychloroquine.

I also wonder about the lack of studies of cohorts where, in retrospect, we could have followed people previously treated with hydroxychloroquine for chronic diseases (e.g., rheumatoid arthritis, lupus, etc.). Or we could identify all those patients on the health insurance system who had prescriptions.

That is how we discovered the AIDS epidemic in San Francisco: There was an increase in the number of prescriptions for trimethoprim/sulfamethoxazole (Bactrim) that corresponded to a population subtype (homosexual), and we realized that it was for a disease that resembled pneumocystosis. We discovered that via the drug!

If hydroxychloroquine is effective, it is enough to look at people who took it before the epidemic and see how they fared. And there, we do not need a control arm. This could give us some direction. The March 26 decree of the new Véran Law states that community pharmacies can dispense to patients with a previous prescription, so we can find these individuals.
 

Do you think that the lack of, or difficulty in setting up, studies on hydroxychloroquine in France is linked to decisions that are more political than scientific?

Perhaps the contaminated blood scandal still casts a shadow in France, and there is a great deal of anxiety over the fact that we are already in a crisis, and we do not want a second one. I can understand that.

However, just a week ago, access to this drug (and others with market approval that have been on the market for several years) was blocked in hospital central pharmacies, while we are the medical specialists with the authorization! It was unacceptable.

It was sorted out 48 hours ago: hydroxychloroquine is now available in the hospital, and to my knowledge, we no longer have a problem obtaining it.

It took time to alleviate doubts over the major health risks with this drug. [Officials] seemed almost like amateurs in their hesitation; I think they lacked foresight. We have forgotten that the treatment advocated by Prof. Didier Raoult is not chloroquine but rather hydroxychloroquine, and we know that the adverse effects are less [with hydroxychloroquine] than with chloroquine.
 

You yourself have treated patients with chloroquine, despite the risk for toxicity highlighted by some.

Initially, when we first started treating patients, we thought of chloroquine because we did not have data on hydroxychloroquine, only Chinese data with chloroquine. We therefore prescribed chloroquine several days before prescribing hydroxychloroquine.

The question of the toxicity of chloroquine was not unjustified, but I think we took far too much time to decide on the toxicity of hydroxychloroquine. Is [the latter] political? I don’t know. It was widely publicized, which amazes me for a drug that is already available.

On the other hand, everyone was talking at the same time about the toxicity of NSAIDs. ... One has the impression it was to create a diversion. I think there were double standards at play and a scapegoat was needed to gain some time and ask questions.

What is sure is that it is probably not for financial reasons, as hydroxychloroquine costs nothing. That’s to say there were probably pharmaceutical issues at stake for possible competitors of hydroxychloroquine; I do not want to get into this debate, and it doesn’t matter, as long as we have an answer.

Today, the only thing we have advanced on is the “safety” of hydroxychloroquine, the low risk to the general population. ... On the other hand, we have still not made any progress on the evidence of efficacy, compared with other treatments.

Personally, I really believe in hydroxychloroquine. It would nevertheless be a shame to think we had found the fountain of youth and realize, in 4 weeks, that we have the same number of deaths. That is the problem. I hope that we will soon have solid data so we do not waste time focusing solely on hydroxychloroquine.
 

What are the other avenues of research that grab your attention?

The Discovery trial will probably give an answer on remdesivir [GS-5734, Gilead], which is a direct antiviral and could be interesting. But there are other studies being conducted currently in China.

There is also favipiravir [T-705, Avigan, Toyama Chemical], which is an anti-influenza drug used in Japan, which could explain, in part, the control of the epidemic in that country. There are effects in vitro on coronavirus. But it is not at all studied in France at the moment. Therefore, we should not focus exclusively on hydroxychloroquine; we must keep a close eye on other molecules, in particular the “old” drugs, like this antiviral.

The study was supported by the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection, the National Research Agency, under the Investissements d’avenir program, Région Provence Alpes Côte d’Azur, and European funding FEDER PRIMI. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A controversial study led by Didier Raoult, MD, PhD, on the combination of hydroxychloroquine and azithromycin in patients with COVID-19 was published March 20. The latest results from the same Marseille team, which involve 80 patients, were reported on March 27.

The investigators report a significant reduction in the viral load (83% patients had negative results on quantitative polymerase chain reaction testing at day 7, and 93% had negative results on day 8). There was a “clinical improvement compared to the natural progression.” One death occurred, and three patients were transferred to intensive care units.

If the data seem encouraging, the lack of a control arm in the study leaves clinicians perplexed, however.

Benjamin Davido, MD, an infectious disease specialist at Raymond-Poincaré Hospital in Garches, Paris, spoke in an interview about the implications of these new results.
 

What do you think about the new results presented by Prof. Raoult’s team? Do they confirm the effectiveness of hydroxychloroquine?

These results are complementary [to the original results] but don’t offer any new information or new statistical evidence. They are absolutely superimposable and say overall that, between 5 and 7 days [of treatment], very few patients shed the virus. But that is not the question that everyone is asking.

Even if we don’t necessarily have to conduct a randomized study, we should at least compare the treatment, either against another therapy – which could be hydroxychloroquine monotherapy, or just standard of care. It needed an authentic control arm.

To recruit 80 patients so quickly, the researchers probably took people with essentially ambulatory forms of the disease (there was a call for screening in the south of France) – therefore, by definition, less severe cases.

But to describe such a population of patients as going home and saying, “There were very few hospitalizations and it is going well,” does not in any way prove that the treatment reduces hospitalizations.
 

The argument for not having a control arm in this study was that it would be unethical. What do you think?

I agree with this argument when it comes to patients presenting with risk factors or who are starting to develop pneumonia.

But I don’t think this is the case at the beginning of the illness. Of course, you don’t want to wait to have severe disease or for the patient to be in intensive care to start treatment. In these cases, it is indeed very difficult to find a control arm.
 

In the ongoing Discovery trial, which involves more than 3,000 patients in Europe, including 800 in France, the patients have severe disease, and there are five treatment arms. Moreover, hydroxychloroquine is given without azithromycin. What do you think of this?

I think it’s a mistake. It will not answer the question of the effectiveness of hydroxychloroquine in COVID-19, especially as they’re not studying azithromycin in a situation where the compound seems necessary for the effectiveness of the treatment.

In addition, Discovery reinforces the notion of studying Kaletra [lopinavir/ritonavir, AbbVie] again, while Chinese researchers have shown that it does not work, the argument being that Kaletra was given too late (N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282). Therefore, if we make the same mistakes from a methodological point of view, we will end up with negative results.
 

What should have been done in the Marseille study?

The question is: Are there more or fewer hospitalizations when we treat a homogeneous population straight away?

The answer could be very clear, as a control already exists! They are the patients that flow into our hospitals every day – ironically, these 80 patients [in the latest results, presented March 27] could be among the 80% who had a form similar to nasopharyngitis and resolved.

In this illness, we know that there are 80% spontaneous recoveries and 20% so-called severe forms. Therefore, with 80 patients, we are very underpowered. The cohort is too small for a disease in which 80% of the evolution is benign.

It would take 1,000 patients, and then, even without a control arm, we would have an answer.

On March 26, Didier Raoult’s team also announced having already treated 700 patients with hydroxychloroquine, with only one death. Therefore, if this cohort increases significantly in Marseille and we see that, on the map, there are fewer issues with patient flow and saturation in Marseille and that there are fewer patients in intensive care, you will have to wonder about the effect of hydroxychloroquine.

We will find out very quickly. If it really works, and they treat all the patients presenting at Timone Hospital, we will soon have the answer. It will be a real-life study.
 

What are the other studies on hydroxychloroquine that could give us answers?

There was a Chinese study that did not show a difference in effectiveness between hydroxychloroquine and placebo, but that was, again, conducted in only around 20 patients (J Zhejiang Univ (Med Sci). 2020. doi: 10.3785/j.issn.1008-9292.2020.03.03). This cohort is too small and tells us nothing; it cannot show anything. We must wait for the results of larger trials being conducted in China.

It surprises me that, today, we still do not have Italian data on the use of chloroquine-type drugs ... perhaps because they have a care pathway that means there is no outpatient treatment and that they arrive already with severe disease. The Italian recommendations nevertheless indicate the use of hydroxychloroquine.

I also wonder about the lack of studies of cohorts where, in retrospect, we could have followed people previously treated with hydroxychloroquine for chronic diseases (e.g., rheumatoid arthritis, lupus, etc.). Or we could identify all those patients on the health insurance system who had prescriptions.

That is how we discovered the AIDS epidemic in San Francisco: There was an increase in the number of prescriptions for trimethoprim/sulfamethoxazole (Bactrim) that corresponded to a population subtype (homosexual), and we realized that it was for a disease that resembled pneumocystosis. We discovered that via the drug!

If hydroxychloroquine is effective, it is enough to look at people who took it before the epidemic and see how they fared. And there, we do not need a control arm. This could give us some direction. The March 26 decree of the new Véran Law states that community pharmacies can dispense to patients with a previous prescription, so we can find these individuals.
 

Do you think that the lack of, or difficulty in setting up, studies on hydroxychloroquine in France is linked to decisions that are more political than scientific?

Perhaps the contaminated blood scandal still casts a shadow in France, and there is a great deal of anxiety over the fact that we are already in a crisis, and we do not want a second one. I can understand that.

However, just a week ago, access to this drug (and others with market approval that have been on the market for several years) was blocked in hospital central pharmacies, while we are the medical specialists with the authorization! It was unacceptable.

It was sorted out 48 hours ago: hydroxychloroquine is now available in the hospital, and to my knowledge, we no longer have a problem obtaining it.

It took time to alleviate doubts over the major health risks with this drug. [Officials] seemed almost like amateurs in their hesitation; I think they lacked foresight. We have forgotten that the treatment advocated by Prof. Didier Raoult is not chloroquine but rather hydroxychloroquine, and we know that the adverse effects are less [with hydroxychloroquine] than with chloroquine.
 

You yourself have treated patients with chloroquine, despite the risk for toxicity highlighted by some.

Initially, when we first started treating patients, we thought of chloroquine because we did not have data on hydroxychloroquine, only Chinese data with chloroquine. We therefore prescribed chloroquine several days before prescribing hydroxychloroquine.

The question of the toxicity of chloroquine was not unjustified, but I think we took far too much time to decide on the toxicity of hydroxychloroquine. Is [the latter] political? I don’t know. It was widely publicized, which amazes me for a drug that is already available.

On the other hand, everyone was talking at the same time about the toxicity of NSAIDs. ... One has the impression it was to create a diversion. I think there were double standards at play and a scapegoat was needed to gain some time and ask questions.

What is sure is that it is probably not for financial reasons, as hydroxychloroquine costs nothing. That’s to say there were probably pharmaceutical issues at stake for possible competitors of hydroxychloroquine; I do not want to get into this debate, and it doesn’t matter, as long as we have an answer.

Today, the only thing we have advanced on is the “safety” of hydroxychloroquine, the low risk to the general population. ... On the other hand, we have still not made any progress on the evidence of efficacy, compared with other treatments.

Personally, I really believe in hydroxychloroquine. It would nevertheless be a shame to think we had found the fountain of youth and realize, in 4 weeks, that we have the same number of deaths. That is the problem. I hope that we will soon have solid data so we do not waste time focusing solely on hydroxychloroquine.
 

What are the other avenues of research that grab your attention?

The Discovery trial will probably give an answer on remdesivir [GS-5734, Gilead], which is a direct antiviral and could be interesting. But there are other studies being conducted currently in China.

There is also favipiravir [T-705, Avigan, Toyama Chemical], which is an anti-influenza drug used in Japan, which could explain, in part, the control of the epidemic in that country. There are effects in vitro on coronavirus. But it is not at all studied in France at the moment. Therefore, we should not focus exclusively on hydroxychloroquine; we must keep a close eye on other molecules, in particular the “old” drugs, like this antiviral.

The study was supported by the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection, the National Research Agency, under the Investissements d’avenir program, Région Provence Alpes Côte d’Azur, and European funding FEDER PRIMI. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A controversial study led by Didier Raoult, MD, PhD, on the combination of hydroxychloroquine and azithromycin in patients with COVID-19 was published March 20. The latest results from the same Marseille team, which involve 80 patients, were reported on March 27.

The investigators report a significant reduction in the viral load (83% patients had negative results on quantitative polymerase chain reaction testing at day 7, and 93% had negative results on day 8). There was a “clinical improvement compared to the natural progression.” One death occurred, and three patients were transferred to intensive care units.

If the data seem encouraging, the lack of a control arm in the study leaves clinicians perplexed, however.

Benjamin Davido, MD, an infectious disease specialist at Raymond-Poincaré Hospital in Garches, Paris, spoke in an interview about the implications of these new results.
 

What do you think about the new results presented by Prof. Raoult’s team? Do they confirm the effectiveness of hydroxychloroquine?

These results are complementary [to the original results] but don’t offer any new information or new statistical evidence. They are absolutely superimposable and say overall that, between 5 and 7 days [of treatment], very few patients shed the virus. But that is not the question that everyone is asking.

Even if we don’t necessarily have to conduct a randomized study, we should at least compare the treatment, either against another therapy – which could be hydroxychloroquine monotherapy, or just standard of care. It needed an authentic control arm.

To recruit 80 patients so quickly, the researchers probably took people with essentially ambulatory forms of the disease (there was a call for screening in the south of France) – therefore, by definition, less severe cases.

But to describe such a population of patients as going home and saying, “There were very few hospitalizations and it is going well,” does not in any way prove that the treatment reduces hospitalizations.
 

The argument for not having a control arm in this study was that it would be unethical. What do you think?

I agree with this argument when it comes to patients presenting with risk factors or who are starting to develop pneumonia.

But I don’t think this is the case at the beginning of the illness. Of course, you don’t want to wait to have severe disease or for the patient to be in intensive care to start treatment. In these cases, it is indeed very difficult to find a control arm.
 

In the ongoing Discovery trial, which involves more than 3,000 patients in Europe, including 800 in France, the patients have severe disease, and there are five treatment arms. Moreover, hydroxychloroquine is given without azithromycin. What do you think of this?

I think it’s a mistake. It will not answer the question of the effectiveness of hydroxychloroquine in COVID-19, especially as they’re not studying azithromycin in a situation where the compound seems necessary for the effectiveness of the treatment.

In addition, Discovery reinforces the notion of studying Kaletra [lopinavir/ritonavir, AbbVie] again, while Chinese researchers have shown that it does not work, the argument being that Kaletra was given too late (N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282). Therefore, if we make the same mistakes from a methodological point of view, we will end up with negative results.
 

What should have been done in the Marseille study?

The question is: Are there more or fewer hospitalizations when we treat a homogeneous population straight away?

The answer could be very clear, as a control already exists! They are the patients that flow into our hospitals every day – ironically, these 80 patients [in the latest results, presented March 27] could be among the 80% who had a form similar to nasopharyngitis and resolved.

In this illness, we know that there are 80% spontaneous recoveries and 20% so-called severe forms. Therefore, with 80 patients, we are very underpowered. The cohort is too small for a disease in which 80% of the evolution is benign.

It would take 1,000 patients, and then, even without a control arm, we would have an answer.

On March 26, Didier Raoult’s team also announced having already treated 700 patients with hydroxychloroquine, with only one death. Therefore, if this cohort increases significantly in Marseille and we see that, on the map, there are fewer issues with patient flow and saturation in Marseille and that there are fewer patients in intensive care, you will have to wonder about the effect of hydroxychloroquine.

We will find out very quickly. If it really works, and they treat all the patients presenting at Timone Hospital, we will soon have the answer. It will be a real-life study.
 

What are the other studies on hydroxychloroquine that could give us answers?

There was a Chinese study that did not show a difference in effectiveness between hydroxychloroquine and placebo, but that was, again, conducted in only around 20 patients (J Zhejiang Univ (Med Sci). 2020. doi: 10.3785/j.issn.1008-9292.2020.03.03). This cohort is too small and tells us nothing; it cannot show anything. We must wait for the results of larger trials being conducted in China.

It surprises me that, today, we still do not have Italian data on the use of chloroquine-type drugs ... perhaps because they have a care pathway that means there is no outpatient treatment and that they arrive already with severe disease. The Italian recommendations nevertheless indicate the use of hydroxychloroquine.

I also wonder about the lack of studies of cohorts where, in retrospect, we could have followed people previously treated with hydroxychloroquine for chronic diseases (e.g., rheumatoid arthritis, lupus, etc.). Or we could identify all those patients on the health insurance system who had prescriptions.

That is how we discovered the AIDS epidemic in San Francisco: There was an increase in the number of prescriptions for trimethoprim/sulfamethoxazole (Bactrim) that corresponded to a population subtype (homosexual), and we realized that it was for a disease that resembled pneumocystosis. We discovered that via the drug!

If hydroxychloroquine is effective, it is enough to look at people who took it before the epidemic and see how they fared. And there, we do not need a control arm. This could give us some direction. The March 26 decree of the new Véran Law states that community pharmacies can dispense to patients with a previous prescription, so we can find these individuals.
 

Do you think that the lack of, or difficulty in setting up, studies on hydroxychloroquine in France is linked to decisions that are more political than scientific?

Perhaps the contaminated blood scandal still casts a shadow in France, and there is a great deal of anxiety over the fact that we are already in a crisis, and we do not want a second one. I can understand that.

However, just a week ago, access to this drug (and others with market approval that have been on the market for several years) was blocked in hospital central pharmacies, while we are the medical specialists with the authorization! It was unacceptable.

It was sorted out 48 hours ago: hydroxychloroquine is now available in the hospital, and to my knowledge, we no longer have a problem obtaining it.

It took time to alleviate doubts over the major health risks with this drug. [Officials] seemed almost like amateurs in their hesitation; I think they lacked foresight. We have forgotten that the treatment advocated by Prof. Didier Raoult is not chloroquine but rather hydroxychloroquine, and we know that the adverse effects are less [with hydroxychloroquine] than with chloroquine.
 

You yourself have treated patients with chloroquine, despite the risk for toxicity highlighted by some.

Initially, when we first started treating patients, we thought of chloroquine because we did not have data on hydroxychloroquine, only Chinese data with chloroquine. We therefore prescribed chloroquine several days before prescribing hydroxychloroquine.

The question of the toxicity of chloroquine was not unjustified, but I think we took far too much time to decide on the toxicity of hydroxychloroquine. Is [the latter] political? I don’t know. It was widely publicized, which amazes me for a drug that is already available.

On the other hand, everyone was talking at the same time about the toxicity of NSAIDs. ... One has the impression it was to create a diversion. I think there were double standards at play and a scapegoat was needed to gain some time and ask questions.

What is sure is that it is probably not for financial reasons, as hydroxychloroquine costs nothing. That’s to say there were probably pharmaceutical issues at stake for possible competitors of hydroxychloroquine; I do not want to get into this debate, and it doesn’t matter, as long as we have an answer.

Today, the only thing we have advanced on is the “safety” of hydroxychloroquine, the low risk to the general population. ... On the other hand, we have still not made any progress on the evidence of efficacy, compared with other treatments.

Personally, I really believe in hydroxychloroquine. It would nevertheless be a shame to think we had found the fountain of youth and realize, in 4 weeks, that we have the same number of deaths. That is the problem. I hope that we will soon have solid data so we do not waste time focusing solely on hydroxychloroquine.
 

What are the other avenues of research that grab your attention?

The Discovery trial will probably give an answer on remdesivir [GS-5734, Gilead], which is a direct antiviral and could be interesting. But there are other studies being conducted currently in China.

There is also favipiravir [T-705, Avigan, Toyama Chemical], which is an anti-influenza drug used in Japan, which could explain, in part, the control of the epidemic in that country. There are effects in vitro on coronavirus. But it is not at all studied in France at the moment. Therefore, we should not focus exclusively on hydroxychloroquine; we must keep a close eye on other molecules, in particular the “old” drugs, like this antiviral.

The study was supported by the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection, the National Research Agency, under the Investissements d’avenir program, Région Provence Alpes Côte d’Azur, and European funding FEDER PRIMI. The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.