Gilead’s experimental antiviral drug received an Emergency Use Authorization (EUA) from the Food and Drug Administration on May 1 to treat severely ill hospitalized COVID-19 patients, which was later modified for expanded access in all hospitalized COVID-19 patients.
The NIH published preliminary results from a clinical trial in late May that showed the drug shortened patients’ path to recovery by about four days (11 days vs. 15 days in the placebo group).
Study authors said the final results were gathered after a complete follow-up and were in line with the preliminary findings. It involved 1,062 patients who were randomly assigned Remdesivir or a placebo for 10 days. Of the total, 85% of patients had a severe course of COVID-19.
The drug shortened the time to recovery by about five days – 10 days vs. 15 for those on the placebo.
“These data reinforce the value of Remdesivir in hospitalized patients,” Dr. John Beigel, associate director of clinical research in the division of microbiology and infectious disease at NIAID, told TIME.
By day 29, all-cause mortality was estimated to be about 11% for Remdesivir and 15% among those taking the placebo. Beigel told the outlet that, despite it not being a statistically significant difference, “it is still a significant improvement." He also reportedly said that the death rates and other improvements together uphold the benefits of Remdesivir.
“Our data show that Remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection,” study authors concluded.
Patients saw a greater benefit when the drug was given earlier on in the illness.
“Our data also suggest that treatment with Remdesivir may have prevented the progression to more severe respiratory disease…” authors wrote, adding that the drug lowered the need for oxygen use, reducing the burden on hospital resources amid the pandemic.
As mentioned in the preliminary findings, study authors advocated for a combination of therapeutic approaches for improved patient outcomes.