SWITZERLAND, APRIL 30 – A US government-run study of Remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.
In a statement on Wednesday, the National Institute of Allergy and Infectious Diseases, which is conducting the study, said preliminary data show patients who received remdesivir recovered faster than similar patients who received placebo.
The finding — although difficult to fully characterize without full, detailed data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.
During an appearance alongside President Trump in the Oval Office, Anthony Fauci, the director of NIAID, part of the National Institutes of Health, said the data are a “very important proof of concept” and that there was reason for optimism. He cautioned the data were not a “knockout.” At the same time, the study achieved its primary goal, which was to improve the time to recovery, which was reduced by four days for patients on remdesivir.
The preliminary data showed that the time to recovery was 11 days on remdesivir compared to 15 days for placebo, a 31% decrease. The mortality rate for the remdesivir group was 8%, compared to 11.6% for the placebo group; that mortality difference was not statistically significant.
That is “the first convincing evidence that an antiviral drug can really benefit Covid-19 patients, specifically hospitalized Covid-19 patients,” said Frederick Hayden, a professor emeritus of clinical virology and medicine at the University of Virginia School of Medicine. “This will change the standard of care in the United States and other countries for the patients who have been shown to be benefited,” he said, adding that determining the exact group that should receive the drug will require further examination of the data.
Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.
Full results from the China study were also released Wednesday.
But the NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.
The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.