A vial of remdesivir, a molecule made by the laboratory Gilead
29 April 2020 14h42
Updated at 23: 59
Glimmer of hope around a drug against the COVID-19
WASHINGTON — The canadian Institutes of health us (NIH) announced on Wednesday that the antiviral drug experimental remdesivir of the laboratory Gilead helped the sick of the COVID-19 hospitalized recover more quickly, according to the preliminary results of a large clinical trial against placebo, including a thousand patients.
“The data show that the remdesivir has a clear, meaningful, and positive to reduce the time of recovery” of patients for the new coronavirus Sars-Cov-2, said Anthony Fauci, director of the Institute of infectious diseases, in the oval Office of the White House.
“It is a proof of concept is very important because this proves that we can block the virus,” said the senior scientist, cautiously optimistic, but says that the remdesivir can now become a standard treatment against severe forms of the disease.
Compared to patients who received placebo, patients treated with the remdesivir, a drug developed against Ebola, but that has never been approved against any disease, recovered in 11 days (median time) instead of 15 days, has detailed a press release from the NIH. The recovery time was shortened by 31% on average, according to the institutes.
Recovery is defined as a hospital discharge or a return to normal activities. The statistical reliability of this result is very high.
On the other hand, the preliminary results do not show if the drug saves lives. The mortality of the group of patients treated by remdesivir was 8 %, compared to 11.6 % in the control group; a difference that is too low to exclude the possibility that this is the fruit of chance.
The trial has included 1063 patients with an advanced form of the COVID and lung problems, on 47 sites in the United States and 21 in Europe and Asia. It is the largest study on the remdesivir for which results are available.
In the presence of Donald Trump, Anthony Fauci explained that the first results were so clear that the decision has been taken to make them public, so that patients being treated by placebo now will be able to have access to the remdesivir.
“When there is clear evidence that a drug works, we have an ethical obligation to immediately inform the members of the placebo group”, he said.
“I can guarantee you that with more people, businesses and researchers, it’s going to improve again”, he said.
“It is very positive,” summed up Donald Trump.
Test of chinese non-conclusive
The american laboratory Gilead had preceded this announcement in a brief news release Wednesday morning, pointing to “positive data”.
This trial, launched on the 21st of February, is in fact one of the most expected, with the european trial Discovery of which we are still waiting the results.
Neither the patients nor the doctors did not know if the solution is injected daily intravenously for 10 days was the remdesivir or the placebo, which looked like medicine, but contained only inactive ingredients.
The announcement of the us government puts into perspective the importance of inconclusive results of a smaller study in china (237 patients), conducted also in comparison with a placebo in ten hospitals of Wuhan in China, and which was published Wednesday by the medical journal The Lancet.
In the trial of chinese patients being treated with the remdesivir did no better than those treated with placebo.
But the size of the trial, halted for lack of patients, because the epidemic is stopped in Wuhan, limit the interpretation of the results.
The U.s. Anthony Fauci has considered the study of china, “not adequate”.
The remdesivir is inserted into the genetic material of the coronavirus and the short-circuiting to prevent it from replicate.
Multiple trials are underway worldwide to test the remdesivir, other antiviral drugs, or hydroxychloroquine, an old drug against malaria.
Hospitals are experimenting with since the beginning of the pandemic these medications on their patients, but it is difficult to determine the real effectiveness in the absence of rigorous testing, following protocols comparable, ideally against a placebo.
To find an effective therapy, it is necessary to also look at the dosage.
Gilead has on this subject made public on Wednesday the results of a clinical trial called SIMPLE, which show that five days of treatment would be as effective as ten days.