Phase 3 Remdesivir Data Shows Uncertain Benefits in Moderately Ill COVID-19 Patients

New data from Gilead Sciences’ late-stage trial of its antiviral remdesivir showed that a five-day course of the drug helped patients with moderate COVID-19 pneumonia, but the finding was of “uncertain clinical importance,” according to researchers.

Patients enrolled in the 600-participant international trial had an increased chance of improvement over those on standard care, but the benefit’s clinical significance wasn’t clear, according to findings published in the Journal of the American Medical Association.

While the five-day antiviral course seemed to help patients, there was no statistically significant difference between patients on the 10-day remdesivir schedule and participants on standard care, the researchers found.

The results are lackluster given that remdesivir is considered the most promising COVID-19 treatment to date. The antiviral is the only drug so far to receive an Emergency Use Authorization from the FDA for treating COVID-19, and the company has already applied to the agency for full approval (DID, Aug. 11).

In July, Gilead announced that data from a phase 3 trial of severe COVID-19 patients showed the drug reduced their risk of mortality by 62 percent. The drug also helped a majority of patients in the company’s compassionate use program (DID, July 13).

Read the full results here: bit.ly/2YmI2Ni. — James Miessler