Remdesivir (Veklury) reduced risk of hospitalizations by 87% compared with placebo in outpatients at high risk of progression to severe COVID-19, a researcher said.
While the raw numbers were small — two in the remdesivir arm versus 15 in the placebo arm — the remdesivir arm had a significantly lower risk of hospitalization (0.7% vs 5.3%, respectively; HR 0.13, 95% CI 0.03-0.59, P=0.008), reported Joshua Hill, MD, of Fred Hutchinson Cancer Research Center in Seattle, during a late-breaking presentation at virtual IDWeek.
That means 95% of patients did not progress to severe disease, he noted, suggesting that there might be subgroups, such as those with hematologic malignancies or transplant patients, who might benefit from the therapy.
“More precision studies, especially in high-risk populations, would be really helpful,” added session moderator Adarsh Bhimraj, MD, of the Cleveland Clinic.
Remdesivir also reduced risk of COVID-related medically attended visits or all-cause death by day 28 — a secondary outcome of the study — by 81%. Again, the numbers were small: five in the remdesivir group versus 21 in the placebo group.
Adverse events (AEs) were comparable between the groups, with no new safety signals reported.
However, enrollment was halted due to the availability of single-infusion monoclonal antibodies and “increasing vaccine rates in the high-risk patient population,” which were both exclusion criteria for the study, Hill said. While the goal of the trial was to enroll 1,264 patients, there were 584 randomized, and 562 who received at least one dose of the study drug.
The NIH COVID-19 treatment guidelines currently recommend remdesivir for patients who are hospitalized and on supplemental oxygen, as well as remdesivir plus dexamethasone for hospitalized patients requiring high-flow oxygen or non-invasive ventilation, but there is insufficient evidence for remdesivir in hospitalized patients who do not require supplemental oxygen.