According to the preliminary results of a clinical trial conducted in the United States on more than a thousand patients, this antiviral helped hospital patients to recover 31% faster.
Four months after the start of the Covid-19 epidemic, the US government created hope on Wednesday by reporting that a recently developed Ebola drug, remdesivir, appeared to have taken hold of the new coronavirus , and had accelerated several days recovering from the most severe cases in a large clinical trial.
This is the most notable therapeutic breakthrough against the coronavirus to date, although experts warn that the full results have not yet been published. While multiple treatments are being tested in hospitals around the world, none has yet proven effective in such a large and rigorous placebo-controlled trial. No vaccine will exist before the end of 2020 at the earliest.
“Clear” and “significant” effect
The American Institutes of Health (NIH) announced that the experimental drug remdesivir from the American laboratory Gilead had helped hospital patients to recover 31% faster, according to preliminary results of a clinical trial against placebo including a thousand patients, United States and elsewhere. “The data shows that remdesivir has a clear, meaningful and positive effect in reducing recovery time” for patients, said Anthony Fauci, director of the Institute of Infectious Diseases who led the trial, in the Oval Office of the White House.
“It is a very important proof of concept, because it proves that we can block the virus,” said the senior scientific official, cautiously optimistic, but who affirms that the mode of action of remdesivir on the virus opens a therapeutic track. crucial to become a standard of treatment. President Donald Trump immediately asked the American Medicines Agency (FDA) to grant emergency use authorization for hospitals, outside of clinical trials, “quickly”.
Gilead Sciences boss Daniel O’Day announced that the laboratory currently has 1.5 million doses that would be donated to treat at least 140,000 patients. Gilead will then sell the remdesivir at an “affordable” price, he told Stat. Veteran of the fight against AIDS, Anthony Fauci, 79, drew a parallel with the first “modest” results in 1986 of AZT, a molecule which paved the way for the great current treatments against HIV.
“Clear evidence” that it “works”
Compared to patients who received a placebo, patients treated with remdesivir, a drug never approved for any disease, recovered in 11 days (median duration) instead of 15 days, detailed an NIH press release, citing statistical reliability very high. However, the preliminary results do not show whether the drug saves lives. The mortality in the remdesivir group was 8%, compared with 11.6% in the control group; a difference too small to exclude that it is the result of chance.
The trial included 1,063 inpatients with advanced form of Covid and lung problems, at 47 sites in the United States and 21 others in Europe and Asia. The treatment, by intravenous injection, lasted 10 days. “When there is clear evidence that a drug works, we have an ethical obligation to immediately inform the members of the placebo group,” added Anthony Fauci. A separate global placebo-free clinical trial by Gilead shows the company Wednesday that five-day treatment is as effective as 10 days, which would treat more patients with a given stock, and reduce the hospitalization time.
Other trials in progress
Multiple trials are underway around the world to test remdesivir, other antivirals or even hydroxychloroquine, a drug against malaria that many hospitals are experimenting with immediately, notably French professor Didier Raoult in conjunction with an antibiotic. The results of the large Discovery trial on 3,200 European patients are particularly awaited. In the meantime, hydroxychloroquine is disputed. The American health authorities formally advised against its use outside the hospital a few days ago because of the risks for the heart.
The Washington announcement puts into perspective the importance of inconclusive results from a small study on remdesivir (237 patients), conducted in ten hospitals in Wuhan, China and published Wednesday by the medical journal The Lancet. In the Chinese trial, patients treated with remdesivir did no better than those treated with placebo. But the size of the trial, interrupted for lack of patients because the epidemic stopped in Wuhan, limits the interpretation of the results.
Remdesivir inserts into the genetic material of the coronavirus and short-circuits it to prevent it from replicating. The NIH must now publish their entire results after evaluation by a scientific journal. Stephen Evans, of the London School of Hygiene & Tropical Medicine, points out that it is unknown, based on Wednesday’s announcements, if any adverse effects have been observed.