The american laboratory Gilead has announced Wednesday that its drug remdesivir, one of the tracks to cure the sick of the COVID-19, had shown “positive” results in a clinical trial against placebo highly anticipated and conducted in partnership with the canadian Institutes of health us (NIH).
But on the same day, the medical journal the Lancet has published disappointing results of a smaller study of china, conducted also in comparison with a placebo, showed that patients treated with the remdesivir, an antiviral drug developed against Ebola, but never approved for any disease, had not done better than those treated with placebo.
It is not unusual that trials may differ, but the study of the NIH-one of the greatest and most expected, with the european trial Discovery of which we are still waiting the results.
For the moment, for the positive results, it is necessary to rely to a press release from Gilead. Institutes of health americans have indicated to the AFP that an “announcement” would be made in the day Wednesday, maybe at a briefing on the new coronavirus in the White House.
“Gilead Sciences has knowledge of the positive data from the study conducted by the national Institute of allergy and infectious diseases on its antiviral drug remdesivir for the treatment of the COVID-19,” said the company.
“Positive” means that patients recovered more quickly, according to the stated objectives of the study, but it is not yet known figures.
The director of the Institute of infectious diseases, Anthony Fauci, showed himself to be cautiously optimistic Wednesday. This is not a victory by K. O., he said in the oval Office next to president Donald Trump, but it is an important ” proof of concept “.
The mortality in the control group is 11 %, compared with 8% in the group remdesivir, according to Anthony Fauci.
“It is very positive,” summed up Donald Trump.
This clinical trial american had started on 21 February and was to include 800 patients Covid-19 in the United States and in other countries.
Neither the patients nor the doctors did not know if the solution is injected intravenously was the remdesivir or the placebo, which looked like medicine, but contained only inactive ingredients.
Failure in China
Multiple clinical trials are underway in Europe, Asia and the United States to find an effective treatment against the COVID-19. The remdesivir is one of the therapies tested, alongside other antiviral drugs or hydroxychloroquine.
The remdesivir is inserted into the genetic material of the coronavirus and the short-circuiting to prevent it from replicate.
Number of hospitals caring for since the beginning of the pandemic to their patients with these drugs, but it is difficult for doctors to determine the real effectiveness in the absence of rigorous testing, following a similar protocol, ideally against a placebo.
It is for this reason that the results of the trial led by the NIH are particularly expected.
For the moment, only the study of china, conducted from 6 February to 12 march in ten hospitals of Wuhan, has been thoroughly assessed and published. Its results had been leaked on April 23, briefly, on the site of the world Health Organization.
237 patients participated, of whom two thirds are processed by the remdesivir. The doctors wanted to over 450 participants, but the pandemic is arrested in Wuhan, before they have been able to achieve this number.
“The treatment by remdesivir does not accelerate healing or reduce the mortality related to the COVID-19 compared to a placebo,” according to a summary of the study, published by The Lancet.
“Unfortunately, our trial has shown that although safe and well tolerated, the remdesivir has not shown significant benefit compared to placebo,” commented the lead author of the study, professor Bin Cao, quoted in a press release from the Lancet.
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 aimed to compare two different doses of remdesivir.
According to these results, treatment of five days allowed to improve the clinical condition of the sick in the same way that a ten-day treatment.