REMDESIVIR injection


AUTHORIZED USE: Treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and severe disease.

Severe disease is defined as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.

MECHANISM OF ACTION: Nucleoside ribonucleic acid (RNA) polymerase inhibitor that inhibits viral RNA synthesis; activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2


NIAID-sponsored randomized, double-blinded, placebo-controlled trial

  • Randomized, double-blind, placebo-control, remdesivir vs. placebo, n= 1063 hospitalized patients
  • Primary clinical endpoint: Time to recovery within 28 days after randomization
  • Preliminary analysis:  Median time to recovery was 11 days (remdesivir) vs. 15 days (placebo) p<0.001), Mortality was 8.0% (remdesivir) vs. 11.6% (placebo), p=0.05

Gilead-sponsored open-label trial

  • Randomized, open-label multi-center clinical trial, n~400 with severe COVID-19 with 5-day or 10-day treatment
  • Primary clinical endpoint: Clinical status assessed by 7-point ordinal scale at Day 14 after randomization
  • Preliminary Analysis: Similar improvement in clinical status in both groups


  • Hepatic adverse reactions: Transaminase elevations, ALT and AST, need for appropriate clinical and laboratory monitoring

REGULATORY PATHWAY: Emergency Use Authorization

  • SARS-CoV-2 can cause  serious or life-threatening disease or condition
  • Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19
  • There is no adequate, approved, and available alternative to the emergency use of
    remdesivir for the treatment of COVID-19



Investigational COVID-19 convalescent plasma

Providing  recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma

Donor eligibility

  • Evidence of COVID-19 documented by a laboratory test or positive serological test
  • Complete resolution of symptoms at least 14 days before donation
  • SARS-CoV-2 neutralizing antibody titers, if available

Patient eligibility

  • Laboratory confirmed COVID-19
  • Severe or immediately life-threatening COVID-19
  • Informed consent



COVID-19 Tips and FAQs

What is Emergency Use Authorization

Updated EUA Webpage

Availability of alcohol-based Hand sanitizer

Medical Countermeasures Initiative (MCMi)

12 tips for grocery shopping

Pet safety

Image credit: Gilead, FDA