Infectious Disease

COVID-19 Roundup: New CDC Guidance, IDSA on Testing Prioritization, FDA on NSAIDs

Treatment Options

The Centers for Disease Control and Prevention (CDC) have created a document detailing the current research into two previously approved drugs (chloroquine and hydroxychloroquine) and one investigational drug (remdesivir) for us in patients with COVID-19 in the US.1

Remdesivir, they wrote, “is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related betacoronaviruses.”

Currently, 3 clinical trials are examining the drug’s effect on patients with COVID-19. Further, the drug has been used in the US and other countries on an uncontrolled compassionate use basis.

Hydroxychloroquine and chloroquine, previously approved treatments that have been used for the treatment of malaria and other inflammatory conditions including rheumatoid arthritis and systemic lupus erythematosus that have been shown to have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses. Hydroxychloroquine has been administered to patients with COVID-19 in the US due to its wide availability.

CDC also note that lopinavir-ritonavir was also tested in a clinical trial in China, but “did not show promise for treatment of hospitalized COVID-19 patients with pneumonia.” It is currently involved in a World Health Organization (WHO) study.

Long-Term Care Guidance

CDC has updated its guidance for preparing long-term care facilities and nursing homes for COVID-19.2

Among the recommendations:

  • Restrict visitation except for certain compassionate care situations.
  • Restrict volunteer and non-essential healthcare personnel.
  • Cancel group activities and communal dining.
  • Implement screening for fever and respiratory symptoms.

They also offer additional guidance on the evaluation and management of healthcare providers and residents with symptoms of respiratory illness and procedures to follow if COVID-19 is suspected.

FDA Emergency Use Authorization

The US Food and Drug Administration (FDA) issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test, which provides results “within hours, rather than days like the existing tests,” they wrote.3

FDA on NSAIDs

In response to recent reporting that treatment with non-steroidal anti-inflammatory drugs (NSAIDs) could worsen COVID-19, the FDA wrote:

“At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available. However, all prescription NSAID labels warn that “the pharmacological activity of NSAIDs in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.”4

IDSA: Prioritization of Diagnostic Testing

The Infectious Diseases Society of America has released recommendations on the prioritization of diagnostic testing for COVID-19. The recommendations offer detailed descriptions of potential cases ranked by tier of necessity for testing.5

Tier 1: Critically ill patients receiving ICU-level care with unexplained viral pneumonia or respiratory failure, regardless of travel history; any patient with fever or signs of lower respiratory tract illness and close contact with confirmed COVID-19 patients within 14 days or history of travel to regions with sustained community transmission; immunocompromised patients, elderly patients, and those with underlying chronic conditions with fever or signs of lower respiratory tract illness; and those with fever or signs of lower respiratory tract illness who are critical to pandemic response.

Tier 2: Hospitalized patients and long-term care residents with unexplained fever and signs of lower respiratory tract illness.

Tier 3: Outpatient-setting patients meeting CDC’s criteria for influenza testing, including those with diabetes, COPD, congestive heart failure, over the age of 50 years, and immunocompromised patients.

Tier 4: Community surveillance as directed by public health and authorities.


—Michael Potts

References:

 

  1. Information for Clinicians on Therapeutic Options for COVID-19 Patients. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html. Updated March 21, 2020. Accessed March 23, 2020.
  2. Preparing for COVID-19: Long-term Care Facilities, Nursing Homes. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/prevent-spread-in-long-term-care-facilities.html. Updated March 21, 2020. Accessed March 23, 2020.
  3. Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic. News release. US Food and Drug Administration; March 21, 2020. Accessed March 23, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic.
  4. FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19. News release. US Food and Drug Administration; March 19, 2020. Accessed March 23, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19.
  5. COVID-19 Prioritization of Diagnostic Testing. News release. Infectious Diseases Society of America; March 17, 2020. Accessed March 23, 2020. https://www.idsociety.org/globalassets/idsa/public-health/covid-19-prioritization-of-dx-testing.pdf.