Nearly a month after federal scientists claimed that an experimental drug had helped patients severely ill with the coronavirus, the research has been published.
The drug, remdesivir, was quickly authorized by the Food and Drug Administration for treatment of coronavirus patients, and hospitals rushed to obtain supplies.
But until now, researchers and physicians had not seen the actual data. And remdesivir, made by Gilead Sciences, has a spotty history. It was originally intended to treat hepatitis, but it failed to do so. It was tested against Ebola, but results were lackluster.
So far, remdesivir has not been officially approved for any purpose. The FDA’s emergency use authorization was not a formal approval.
The long-awaited study, sponsored by the National Institute of Allergy and Infectious Diseases, appeared on the New England Journal of Medicine website Friday evening. It confirms the essence of the government’s assertions: Remdesivir shortened recovery time from 15 days to 11 days in hospitalized patients. The study defined recovery as “either discharge from the hospital or hospitalization.”
The trial was rigorous, randomly assigning 1,063 seriously ill patients to receive either remdesivir or a placebo. Those who received the drug not only recovered faster but also did not have serious adverse events more often than those who were given the placebo.
It was an international trial, with most sites in the United States. Patients were assessed daily, and those administering the evaluations did not know whether a patient had been given remdesivir or the placebo.
A monitoring board reviewed the data at specified intervals and called for a halt to the study when there was clear evidence that the drug was effective.
On April 29, NIAID issued a news release stating as much. But infectious disease doctors were frustrated, because they did not have access to the findings, which might have affected how patients were treated.
“For God’s sake, this is a pandemic; we need some data,” said Dr. Judith Feinberg, vice chairwoman of research at West Virginia University School of Medicine.
Publication of the paper has brought some relief. But despite generally positive results, the researchers caution that the drug is far from ideal.
“Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” they concluded.