Remdesivir: no spectacular effectiveness

Remdesivir, this potential treatment for Covid-19, proves to be ineffective in a first clinical trial in severe patients, but another trial announced by the National Health Institute could contradict the latter. However, we should mourn the spectacular effects.

Remdesivir Has Significant Beneficial Effects In Patients Covid-19. This is the announcement made by Anthony Fauci, the director of the American National Institute of allergies and infectious diseases (NIAD). However, it will be necessary to wait until the data are published to judge the credibility of this announcement. Nevertheless, the Review in question is rigorous and has a methodology in accordance with the standards of clinical tests. However, another study published at the same time in the newspaper The Lancet by a Chinese team slightly moderates this announcement: remdesivir would not have significant efficacy in severe patients.

Remdesivir is a recent antiviral drug, originally designed to fight against the Ebola virus but which was never authorized, due to the lack of convincing clinical trials. It is marketed by the Gilead laboratory which has also announced successful trials but whose methodology leaves something to be desired. From the start, this drug has been considered a promising avenue in the fight against Covid-19. Indeed, as for hydroxychloroquine, studies show that it inhibits the replication of SARS-CoV-2 in vitro. But the evidence in vitro are far from sufficient. To judge its benefit / risk balance in the fight against Covid-19, it is necessary to have the results of randomized controlled trials.

Gilead and NIH announcements

The Gilead laboratory published yesterday, on its site, the forthcoming publication of a trial demonstrating that remdesivir was effective by administering it only for five days instead of ten. This Review does not include a control group or blinding procedure. In other words, its level of evidence will be very low, regardless of the meaning of the results. It will not be the study that will decide the scientific debate on treatments. For that, Discovery will probably do much better.

At the same time, the National Instituite of Health (NIH, USA) announced that the results of a clinical Review multicentric (in over 100 sites), randomized, controlled and double-blind showed positive results over time healing (-31%, significant result) and on mortality (11% versus 8%, non-significant result) in more than 800 patients. The data cannot be consulted to date even if the official announcement live from the White House can only inspire. We must therefore be careful and wait for their publication, especially since we can see that primary criteria such as death have been passed in secondary criteria along the way.

The study of Lancet 

However, we can somewhat temper this news. Indeed, yesterday, a Chinese study published in the newspaper The Lancet concludes that the treatment is ineffective for severe patients. It's a randomized study, Controlled, double blind, with 237 severe patients who received 200 milligrams (mg) of remdesivir on 1er day and 100 mg the following days, for 10 days. There are slightly more hypertensive patients and diabetics in the remdesivir group and slightly more heart patients in the group placebo, even if all comorbidities remains equivalent in both groups.

Before that, patients were given various and varied medications like antibiotics or even corticosteroids in similar proportions in both groups. Sure the six primary criteria that needed to be measured, ie discharge from hospital, hospitalization without oxygen or with oxygen, with a therapy invasive or non-invasive breathing and finally death, remdesivir does not show any significant improvement. On secondary criteria such as the time of remission clinical and the decline in viral load neither do patients.

Nevertheless, the patients were enrolled in the experiment between 10 to 12 days after the onset of the disease, which may play a role in the effectiveness of the treatment. The researchers themselves recognize the limits of their studies: insufficient statistical power to detect presumed differences in clinical results, the initiation of treatment rather late in the disease. Initially, the researchers wanted to recruit almost 500 patients, but this apparently was not possible.

As we said, the effect of remdesivir, if it is real, is undoubtedly not spectacular as its benefit / risk balance. The danger is to get carried away with these unclear studies and create a "new tamiflu »Including clinical data are very controversial.

But, in the fight against Covid-19, even small profits are good to take. When the NIAD study is published, it will give us more information about the presumed effectiveness of remdesivir. In the meantime, prudence is the mother of safety. Currently, 19 other studies are underway regarding remdesivir, including four French ones.

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