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COVID-19: Management

Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data

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NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date

SUMMARY:

The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The approval is based on the NIH’s clinical trial showing “promising results.”

  • An EUA is different than a full FDA approval
    • An EUA is based on an FDA evaluation of evidence and risks vs potential or known benefits of of “unproven” products during an emergency
  • The FDA states

The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease

Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator

It was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use

KEY POINTS:

NIH Remdesivir Trial

  • RCT involving 1063 patients:
    • Adaptive COVID-19 Treatment Trial (ACTT)
    • Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)
    • Multicentered (including US, UK, and Singapore)
    • Started in February 2020
    • Current primary endpoint: Being well enough for hospital discharge or returning to normal activity level

Preliminary Data

  • Time to recovery
    • Median time to recovery: 11 days for remdesivir group vs 15 days for placebo group
    • 31% faster time to recovery in remdesivir group vs placebo (p<0.001)
  • Mortality Rate
    • 8.0% in remdesivir group vs 11.6% for the placebo group (p=0.059)
    • “Suggests benefit” but not statistically significant
  • Second (next) stage of trial
    • Remdesivir in combination with another agent | Likely to be a janus kinase inhibitor
  • One of the investigators (UK team) stated (April 30, 2020)

As far as the results are concerned, it’s cautious optimism

There is some effect but it is not a wonder effect

We have to find out when is the best time to give this drug, who benefits more

There is still a lot of data to come out of this trial

Learn More – Primary Sources:

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19

Covid-19: Remdesivir is helpful but not a wonder drug, say researchers (BMJ)

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Related ObG Topics:

ARDS, Critical Care and COVID-19: ‘Surviving Sepsis Campaign’ Guidelines and Key Points
COVID-19 Guidance: Key Highlights for Healthcare Professionals
Remdesivir for COVID-19: RCT Results from 10 Hospitals in China

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