A randomized clinical trial involving more than 1000 patients showed that Remdesivir can Block the replication of the virus thus enabling a faster recovery in patients. The first Chinese randomized study however showed that this antiviral agent did not provide significant benefits in late and severe forms of the disease.
Can an antiviral medication such as Remdesivir be a new hope in the treatment of Covida-19? An American randomized study with more than 1,000 patients, which Professor Anthony Fauci mentioned during a White House briefing, showed promise. We do not yet know the details of this latest study except that it could help hospitalized patients recover 31% faster and that the Remdesivir could block the replication of the virus.
An earlier study conducted in China on 237 hospitalized patients with severe forms of Covid-19 concluded that Remdesivir did not significantly accelerate recovery or reduce the number of deaths compared to placebo. But this randomized study, conducted in Wuhan and published in The Lancet, was terminated prematurely due to difficulties in recruiting patients during the epidemic in that country. Although the efficacy of the drug in this trial remains uncertain, there were still some positive signs.
The trial sponsored by the NIH and the National Institute of Allergy and Infectious Diseases in the United States has been completed and is considered positive. It recruited 1,063 patients with a positive Covid-19 test who were also on oxygen; they received either Remdesivir or placebo (same protocol as the study published in the Lancet earlier). The mean recovery time was 11 days in the Remdesivir group compared to 15 days in the placebo group, a significant 31% reduction.
There is no publication yet, but at the White House briefing, Professor Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said the treatment may accelerate the healing of coronavirus-infected patients. The improvement in cure time “does not appear to be a 100% knockout,” admitted Professor Fauci. “There were also fewer deaths in the Remdesivir group, but` the results were not statistically significant. Remdesivir should become a standard procedure for Covid-19 said Dr. Fauci
Dr. Fauci speaks on the clinical trial for potential coronavirus treatment drug remdesivir:
“What it has proven is that a drug can block this virus … This drug happens to be blocking an enzyme that the virus uses." pic.twitter.com/hFTPUIa8No
— NBC News (@NBCNews) April 29, 2020
Potential benefits of early treatment
The Chinese randomized Lancet study also showed that the time to clinical improvement and the duration of invasive ventilation (intubation) was shorter. But only in patients treated within 10 days of the onset of symptoms.
Interpretation of these results is limited due to the premature termination of the study due to insufficient recruitment of patients with epidemiological control, but this would suggest that patients should be treated with antiviral drugs before day 10, the period from which the disease could become both viral and inflammatory, which complicates pathophysiology and treatment.
However, in contrast to the American study treatment with Remdesivir in the Chinese study did not significantly reduce viral load in the upper or lower airways.
Antiviral agent developed to treat Ebola
Remdesivir is an antiviral drug that was originally developed against the Ebola virus. It is a prodrug and an analog to RNA nucleotide polymerase inhibitors, an enzyme necessary for the replication of SARS-CoV-2, a virus against which Remdesivir has shown in vitro activity.
Animal studies have shown that Remdesivir is also effective against other coronavirus infections such as Severe Acute Respiratory Syndrome (SARS), Middle Eastern Respiratory Syndrome (MERS) and against SARS-CoV-2 in animal studies.
Observational studies have also shown the benefit of Remdesivir in some critically ill patients with Covid-19, but there have been no randomized trials. One study appears to have specified the doses needed and the duration of treatment (5 days).
Problem with trials during a pandemic
The Lancet study, a randomized double-blind study in critically ill patients, which was terminated prematurely, illustrates the difficulty of conducting qualitative studies during a pandemic. This is a challenge in this context, but the temptation to reduce the level of evidence must be resisted, as accepting ineffective and potentially dangerous treatment strategies will only harm patients and make it even more difficult to start the necessary studies.
The U.S. National Institute of Health and the Gilead Laboratory have done just that and appear to be conducting a qualitative trial. The results have prompted the FDA, to put its approval on the fast track.