October 19, 2020 -- A large study sponsored by the World Health Organization found that remdesivir doesn’t help hospitalized patients with COVID-19 survive and doesn’t even shorten the recovery time of those who do survive.
These findings contradict smaller studies which found remdesivir, an antiviral drug, helped hospitalized coronavirus patients recover faster than patients who received a placebo. Those earlier studies led the FDA to grant emergency use authorization for the drug, which has been given to thousands of COVID patients in the United States, including President Donald Trump.
The WHO-sponsored study was conducted from March 22 to Oct. 4 and involved 11,330 patients from 405 hospitals in 30 countries. Patients were given remdesivir and three other drugs singly or in combination.
“These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” the study concluded.
The data was posted online in the preprint server medRxiv and has not been peer-reviewed or published in a scientific journal.
U.S. pharmaceutical company Gilead Sciences, the maker of remdesivir, issued a statement defending the drug, noting that controlled studies published in peer-reviewed journals validated its benefits.
Gilead also questioned how the study was conducted, saying there was variation in “trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results.”
Dr. Peter Chin-Hong, MD, an infectious-disease expert at the University of California, San Francisco, told The New York Times that a massive study in different nations could result in inconsistent treatment methods.
“So much goes into care,” he said. “The drug is only part of it.”
Remdesivir was developed to treat Ebola and was repurposed to treat coronavirus. It has been one of the few encouraging developments in the global battle against COVID-19.
“It’s certainly disappointing,” Julie Fischer, an associate research professor in the Department of Microbiology and Immunology at Georgetown University, said of the study, according to Al Jazeera. “What all of us would like to see is what is frequently called a ‘magic bullet’; a drug that’s already in existence, that is safe and works effectively in patients. Unfortunately, in this case, this trial at least suggests the benefits of remdesivir weren’t there at all.”
The FDA granted emergency use authorization to remdesivir in April, saying: "While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients."
A clinical trial of about 1,000 patients conducted by the National Institutes of Health found remdesivir shortened recovery time in about 31% of patients. The NIH also said the trial “suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.”
But the WHO-sponsored study said remdesivir and the other drugs just didn’t work.
“The unpromising overall findings from the regimens tested suffice to refute early hopes, based on smaller or non-randomized studies, that any will substantially reduce inpatient mortality, initiation of ventilation or hospitalisation duration,” the study said.