The antiviral drug remdesivir sped up recovery from COVID-19, but researchers said the drug requires a supplement and showed little benefit in many groups of patients, peer-reviewed data from a study promoted by health officials shows.
The data shows that the experimental drug shortened the average time to recovery from 15 days to 11 days. One group was given a 10-day course of remdesivir intravenously while another was given standard care and a placebo.
The double-blind, randomized trial included 1,063 patients in 10 countries.
“Preliminary results of this trial suggest that a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” researchers wrote in the New England Journal of Medicine.
The results are preliminary because an independent data and safety monitoring board recommended to unblind the results after an analysis showed remdesivir sped up recovery from COVID-19. It’s not clear whether the trial is continuing.
Researchers noted a high mortality rate in patients, despite the use of remdesivir.
“These preliminary findings support the use of remdesivir for patients who are hospitalized with COVID-19 and require supplemental oxygen therapy,” with the largest benefit observed among patients who required oxygen supplementation but weren’t mechanically ventilated, said the team, which was led by scientists from the National Institute of Allergy and Infectious Diseases (NIAID).
“However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient. Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in COVID-19.”
A study launched earlier this month is evaluating remdesivir with baricitinib, an anti-inflammatory medicine, compared with remdesivir alone.
Treatment should start before the progression of COVID-19 advances so much that patients need assistance breathing, according to the new findings.
Zain Chagla, an infectious disease physician at St. Joseph’s Healthcare Hamilton in Toronto, said the study showed that no groups recovered faster except for patients requiring supplemental oxygen.
“Bottom line – if you come to hospital and you need a bit of oxygen, this drug may get you home faster. But in some cohorts your risk of dying is very small if you fit into that category (some studies 0 percent). This is not a gamechanger. This is a negative trial,” he said in a statement.
Eric Topol, founder and director of the Scripps Research Translational Institute, told STAT News that the study shows remdesivir is “a very safe and effective drug,” although there was no sign of improvement for patients with the most severe cases.
“We now have a definite first efficacious drug for COVID-19, which is a major step forward and will be built upon with other drugs, [and drug] combinations,” he said.
Initial results from the trial were released last month and quickly promoted by health officials, including NIAID head Dr. Anthony Fauci, who said remdesivir “has a clear-cut, significant positive effect in diminishing the time to recover.”
While questions arose about the endpoint being changed during the trial, the Food and Drug Administration authorized emergency use of remdesivir to treat CCP virus patients, and federal health officials started distributing doses donated by maker Gilead Sciences to over a dozen states.
Findings for mortality weren’t statistically significant enough, researchers said, but suggested a survival benefit, with a mortality rate of 7.1 percent for those given remdesivir versus 11.9 percent of the placebo group.
Forty-nine patients had to discontinue remdesivir treatment before day 10 because of an adverse event or because they withdrew, researchers said. Serious adverse events occurred in 21.1 percent in the remdesivir group and 141 patients, or 27 percent, in the placebo group.
Gilead, based in California, responded positively to the results.
“These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated,” Dr. Merdad Parsey, Gilead’s chief medical officer, said in a statement.
The company expects results from a separate phase 3 study to be published soon.