FDA Emergency Authorization: is Remdesivir a COVID-19 Treatment?

Remdesivir is an intravenous antiviral medication initially designed to treat Ebola. It has had in vitro activity against SARS and MERS coronaviruses. It is actively being studied against COVID-19.
Remdesivir is an intravenous antiviral medication with hopes of treating COVID-19.

Remdesivir is an intravenous antiviral medication originally developed for Ebola. It gained interest in treating COVID-19 because of in vitro activity against SARS-CoV-2 and other SARS and MERS coronaviruses. On May 1 the FDA announced:

It is reasonable to believe that the known and potential benefits of [remdesivir] outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19

Denise Hinton, FDA Chief Scientist

This means remdesivir remains an investigation drug with no approved use, but because of the COVID-19 crisis, emergency use is being allowed to severely ill hospitalized patients. The FDA’s decision came from recent higher quality trials.

For those interested, I’ve explained the data from these trials, side effect profile, and compassionate-use findings at the end of this post.

Remember, remdesivir is an IV medication, it is not meant for prevention of COVID-19 or to take at home!

Let’s stay hopeful that further studies will provide more evidence of efficacy against COVID-19. In the meantime, we need to put our efforts in prevention. Later this week I will cover recent data from NYC and Northern California that provide some insights into how we can prevent ourselves from being hospitalized.

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Results of 2 Key Trials on Remdesivir

Study 1: through the NIH, studied on ~1100 hospitalized COVID-19 patients.

  • Recovery time (no longer needing supplemental oxygen or hospitalization) was 31% faster. That was 15 days vs 11 days.
  • Death rate: while the raw number was lower on remdesivir (8.0 vs 11.6%) it was not statistically significant.

Take home: remdesivir reduced symptoms duration but did not result in fewer deaths.

Study 2: in China studied ~240 hospitalized COVID-19 patients.

  • The study was “underpowered” meaning it failed to recruit enough patients to determine whether remdesivir was effective.
    • The study stopped early because the COVID-19 crisis came under control in Wuhan.
  • From their data, remdesivir did not result in clinical improvement versus placebo.

Take home: remdesivir was not associated with significant clinical benefit. The study was too small, however, so larger studies may show different results.

What Were Findings From Compassionate Use of Remdesivir?

Remdesivir began being studied against COVID-19 through “compassionate use”. That means patients received an experimental medication without being in a formal trial.

Side effects affected 60% but only 8% needed to discontinue treatment because of them. Side effects included:

  • Liver problems
  • Rash
  • Kidney problems

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The information provided in this post in intended for general education. It is not medical advice. While I make every effort to provide the most up-to-date information, please note that new data is continuously becoming available and may change the conclusions I present here.

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