The primary objectives of this Phase 3 study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.

Initially 585 participants were scheduled for this clinical trial, however this trial was terminated due to study enrollment feasibility and changing needs of non-hospitalized patients. This decision is not based on efficacy or safety concerns.

Results

On September 22, 2021 Gilead Sciences, Inc. announced positive results from this trial.

In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In the study, no deaths were observed in either arm by Day 28.

Enrollment for this trial was stopped prior to fulfilling enrollment targets in April 2021, reflecting the changing epidemiology and adoption of additional treatment options at the time; however, the study continued to collect data on enrolled participants and both investigators and participants remained blinded to their assignment of Veklury or placebo. These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression.