The good news is that results from the first official findings from the randomized trial of the antiviral drug remdesivir could come out earlier than anticipated, in the first weeks of May. The bad news is that the results might not be all we hoped for.
Remdesivir was first trialed against Ebola a few years ago, but it didn’t seem to go as well as was hoped for. The antiviral treatment recently gained a lot of attention as a potential treatment for COVID-19, with some promising preliminary results.
For instance, doctors at Houston Methodist Hospital told Reuters that since March 23, they have treated 41 mostly severely ill COVID-19 patients with the drug. None have died and half are back home. But this was not done in a clinical setting and therefore it’s impossible to know how much of this positive effect was owed to the drug itself, and how much was accounted for by other factors.
Several other hospitals shared similar data, and in early April 2020, remdesivir was viewed as the most promising potential treatment for COVID-19 by Johns Hopkins University. But things don’t look so good now.
The first negative data came with a draft published “by mistake” on the World Health Organization website summary. This was picked up by the media, who saved a screenshot of the study. The presented summary said the Chinese trial involved 237 patients, with 158 on the drug and 79 in a control group. Remdesivir was stopped early in 18 patients because of side effects. After a month, 13.9 percent of the patients on remdesivir had died compared to 12.8 percent of those in the control group — a difference too small to be considered statistically significant.
However, Gilead (the company manufacturing remdesivir) said that negative characterization of the media is unwarranted.
“We believe the post included inappropriate characterizations of the study,” saying it was terminated early due to low enrollment and was therefore not statistically meaningful.
“As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease,” the spokesman added.
For now, it’s pretty unclear just how much potential remdesivir has, but there are already several large-scale trials ongoing, and a few are already in advanced stages. This means that in the not-too-distant-future, we could get a much clearer picture.
For instance, a very rigorous study supported by the NIH is set for publication in May. This is a randomized, double-blind, placebo-controlled trial, which means that the study compares patients who received remdesivir to those who didn’t, and neither the doctors nor the patients know who is getting the real drug and who is getting a placebo (to avoid all possible biases).
The study, which features patients from all around the world, progressed faster than expected and enrolled more patients than initially planned.
Dr. Andre Kalil, principal investigator for the trial, said he wants to see results that show “meaningful clinical benefits” for patients.
