What is Remdesivir, the new wonder drug for COVID-19?

by | Jul 25, 2020 | Uncategorized | 229 comments

 

Got many questions about the drug after Dr Fauci announced the NIH study today. Here are some pearls about the ACTT or Adaptive COVID-19 Treatment Trial.

Remdesivir:

— broad-spectrum anti-viral drug

— given intravenously daily for 10 days

— no oral form yet

— developed by Gilead labs

— investigational drug

— previous trials for Ebola, MERS, and SARS

Methods:

— February 21 to April 19

— multi-center trial: 47 in USA, 21 in Asia and Europe

— randomized placebo controlled clinical trial

— study was double-blind, meaning trial investigators and participants would not know who is receiving remdesivir or placebo

— there were two groups of patients with COVID. One group got Remdesivir and the other got a placebo (sham drug or saline infusion)

— enrolled 1063 patients

— patients had to be SARS-COV2 positive, hospitalized, and with lung disease including rattling sounds when breathing and on oxygen, or abnormal chest X-rays, or on a ventilator

— those with confirmed positive test who had mild symptoms or no symptoms not included in the study

— 200 md IV Remdesivir given on day one, then 100 mg daily for 9 days

— placebo group got a solution with inactive ingredients

— primary endpoint was “time to recovery”

— recovery was defined as being well enough for hospital discharge or returning to normal activity level

— the trial was stopped early due to ethical reasons as the drug was so clearly effective that the placebo group could not be deprived of it

Results:

— Remdesivir was better than placebo for “time to recovery”

— Median time to recovery was 11 days with remdesivir compared with 15 days with placebo

— This is a 31% difference (p<0.001)

— Results also suggested a survival benefit, with a mortality rate of 8% for remdesivir versus 11.6% for placebo (p=0.059)

— The p value is the probability that the difference is due to chance and chance alone. It must be very low for the study to show superiority of one treatment over another.

Conclusion:

— data supports early Remdesivir treatment initiation in COVID-19 in a subgroup of seriously ill patients

My Concerns worth $0.02:

— not peer reviewed, not published yet

— need to see the full study to analyze statistical methods

— involvement of Gilead worrisome. Documented Competing Interest Statement – “The authors affiliated with Gilead Sciences are employees of the company and own company stock. The authors affiliated with NIH have no conflict of interest to report”

— mortality data (8% vs 11.6%) not impressive

— long term safety profile of Remdesivir unknown

— only appropriate for severely ill hospitalized patients, no outpatient treatment for mild cases

Hope this was helpful!

Read the article here: https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

 

Remdesivir

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