Gilead Study Shows Remdesivir Reduced Risk of Hospitalization When Given to COVID-19 Patients Early

Gilead Study Shows Remdesivir Reduced Risk of Hospitalization When Given to COVID-19 Patients Early
A sign is posted in front of the Gilead Sciences headquarters in Foster City, Calif., on April 29, 2020. (Justin Sullivan/Getty Images)
Zachary Stieber

The antiviral remdesivir treatment reduced the risk of hospitalization among COVID-19 patients when administered soon after they were diagnosed, according to a new study from Gilead Sciences, which developed remdesivir.

Researchers found that remdesivir cut the risk of hospitalization by 87 percent compared to a placebo that half of the study participants received.

A total of 562 patients, all deemed at high-risk from COVID-19, were enrolled in the trial.

The Phase 3 study was a randomized, double-blind trial, but trial enrollment stopped in April because the company struggled to find enough participants. It continued to follow those who had enrolled, half of whom were given a placebo.

The new study showed a similar safety profile to the placebo and no deaths occurred in either group by the primary endpoint at day 28, though one person who was given the placebo died on day 59, Gilead said.

Gilead later shared its data with the Food and Drug Administration and got the results published in the New England Journal of Medicine.

Competing Treatment Options

Participants received the antiviral through IV on three consecutive days as nonhospitalized patients. That’s impractical for people outside of hospitals, some experts say.

Chandy John Lab, professor of pediatrics at the Indiana University School of Medicine, wrote in a social media post that monoclonal antibodies are designed to prevent hospitalization and only require a single dose, making them a preferred treatment option over remdesivir. Both cost thousands of dollars.

Remdesivir, also known as Veklury, is already approved by U.S. drug regulators for use against COVID-19 in patients who are already hospitalized, 12 or older, and weigh at least 88 pounds. Gilead wants its drug to compete with monoclonal antibodies, which are now in high demand after the Biden administration rationed them.

Remdesivir has been touted by top U.S. officials in the past, including Dr. Anthony Fauci. But other research has suggested that it has no benefit, including a trial across 48 sites in Europe.

“No clinical benefit was observed from the use of remdesivir in patients who were admitted to hospital for COVID-19, were symptomatic for more than 7 days, and required oxygen support,” researchers wrote in The Lancet last week.
Some studies have also linked the drug to kidney disease and other severe side effects.
Editor’s Note: This article has been updated with details about side effects linked to remdesivir.