Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, says preliminary results of a placebo-controlled, randomized trial with the Gilead Sciences drug remdesivir shows positive results in treating COVID-19. Fauci spoke from the White House as President Donald Trump was meeting with the Governor of Louisiana and economic experts.
Dr. Fauci says the trial is being done by the National Institute of Allergy and Infectious Diseases, and was started February 21, 2020 and compared remdesivir with a placebo. It has around 1,090 individuals in countries around the world (Germany, Denmark, Spain, Greece, the U.S. among others) and is the first, as Fauci said, “high powered” trial. The primary end point was the time to recovery, the ability to be discharged from the hospital.
The Data and Safety Board, an independent group separate from the study team, responsible for monitoring the trial, contacted Dr. Fauci and the study team to say that that the data shows that remdesivir has a “clear cut, significant positive effect in diminishing the time to recovery.” Dr. Fauci said this is highly significant. Time to recovery –release from the hospital– was 11 days compared to the control group of 15 days. Dr. Fauci said this may not sound like much, but this is an important proof of concept that shows that a drug can block this virus.
The mortality rate in the study trended towards being better, ie fewer deaths, 8% vs 11% in the placebo group. Dr. Fauci said that does not reach statistical significance, but it is a very important proof of concept. Whenever there is clear cut evidence that a drug works, there is an ethical obligation to inform those in the placebo group so they can have access to the drug, and that’s why the Data and Safety Board for this trial alerted Dr. Fauci an the study team.
Dr. Fauci said these results are being finalized and will be submitted for peer review.
Fauci said remdesivir blocks an enzyme in the virus. He stressed, remdesivir is not a vaccine, which will prevent infection in those at risk for getting COVID-19, and has no impact on vaccine development. He said this trial of remdesivir is focused only on those who already have COVID-19.
Dr. Fauci said this reminded him of his work in 1986 when the HIV drug AZT showed positive results, which allowed researchers to build on AZT to find similar drugs to help combat HIV/AIDS.
Click here for the full Gilead Sciences press release on this trial.