The early results, emerging from a large clinical trial sponsored by the National Institute of Allergy and Infectious Diseases, appears to position the drug as the standard therapy for hospitalized COVID-19 patients going forward.
In the trial, patients who received remdesivir recovered 31% faster than those who received a placebo, a finding of superiority that could not be attributed to chance, researchers reported.
Specifically, half of the patients who were randomly selected to be treated with remdesivir were considered completely recovered within 11 days, and half of those patients took longer. By comparison, it took 15 days for half of those who received the placebo to recover.
The results also suggested that patients who were given remdesivir were more likely to survive COVID-19 than were those who got the placebo. But the difference in fatality rates — 8% for the group that took the drug versus 11.6% for the placebo group — fell slightly below the cutoff point at which researchers could rule out a statistical fluke.
Remdesivir was originally designed by California-based Gilead Sciences Inc. as a drug to treat Ebola disease. But since it was less effective than other medications for that use, the experimental drug never entered full-scale production.
Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases, hailed the new findings as a “really quite important” milestone in the scramble to find any effective treatment for a pandemic that has claimed more than 224,000 lives around the world, including 58,355 in the United States.
“What (the clinical trial) has proven is that a drug can block this virus,” Fauci said on Wednesday in the Oval Office of the White House. “This drug happens to be blocking an enzyme that the virus uses.”
Indeed, the benefits were so clear that researchers halted this portion of the trial early. As they move on to investigate other drugs against COVID-19, researchers will give all trial participants remdesivir and will make the antiviral the new standard against which other drugs are compared, Fauci said.
“Whenever you have clear-cut evidence that a drug works,” he explained, “you have an ethical obligation to immediately let the people who are in the placebo group know so that they could have access.”
Fauci added that after the data had been analyzed more completely, “some of the numbers may change a little, but the conclusion will not change.”
Fauci, who took the helm of the infectious-disease agency in 1984, likened the new findings to the 1986 discovery that the anti-retroviral drug azidothymidine, or AZT, could suppress the HIV virus in patients with AIDS. That drug, which became known as Retrovir, marked the beginning of a turnaround that transformed HIV infection from a death sentence into a manageable chronic health condition.
On Wednesday, Fauci suggested the remdesivir results could upend a welter of other clinical trials now underway to explore potential treatments for COVID-19.
“All of the other trials that are taking place now have a new standard of care,” he added.
The NIAID trial began on Feb. 21 and enrolled 1,063 patients across the country. The first participant was an American who became ill after traveling on the Diamond Princess cruise ship and was treated at the University of Nebraska. A total of 68 sites ultimately joined the study, including 47 in the United States and 21 in Europe and Asia.
The U.S. Food and Drug Administration has been working with Gilead Sciences to make remdesivir available to patients as quickly as possible, NIAID officials said.
Separately, Gilead announced Wednesday that remdesivir appeared to be equally effective at shortening COVID-19 illness when it’s administered at half the dose currently considered necessary. That trial compared patients who received the drug for five days with patients who took it for the usual 10 days.
That’s welcome news considering that the drug is not yet rolling off of production lines in large quantities. With limited stocks now in hand, and coronavirus cases continuing to pile up, the new findings suggest the medication could go twice as far as previously thought possible.
The new findings are set against a backdrop of considerable uncertainty about remdesivir’s effectiveness. In addition to the NIAID trial, two other major clinical trials are now underway across the country.
All told, in close to 7,500 patients at more than 430 hospitals and care centers, the disease trajectories of patients on remdesivir are being rigorously compared to those of patients getting a range of other treatments.
The results of early studies have been promising but mixed.
In a preliminary report published this month in the New England Journal of Medicine, remdesivir appeared to reduce the risk of death in severely ill COVID-19 patients and improve the condition of those who required a range of devices for breathing assistance. Researchers reported that 68% of the patients saw their symptoms improve within 28 days, and 13% died.
That study, however, tracked the outcomes of just 53 patients and did not compare them with patients who did not get remdesivir.
Researchers in China who did put remdesivir head-to-head against a placebo found that the drug appeared to make no significant difference in how sick patients became or how quickly they recovered.
Their study, published Wednesday in the medical journal Lancet, was a double-blind trial in which neither patients nor the doctors treating them knew who got the drug and who got the placebo. That trial design is considered the gold standard of medical research.
The researchers, however, were only able to enroll 237 of the 453 patients they thought they would need to be able to detect a benefit with remdesivir. They drew study volunteers from 10 hospitals in Wuhan, but as outbreak conditions improved there, they ran out of patients to recruit.
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