Positive results were announced from a phase 3 trial evaluating the efficacy and safety of a 3-day course of intravenous remdesivir in nonhospitalized COVID-19 patients at high risk for disease progression.
The randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04501952) included 584 nonhospitalized patients diagnosed with COVID-19 who were considered at high risk for disease progression based on comorbidities and age. Patients were randomly assigned 1:1 to receive a 3-day course of either remdesivir or placebo. The primary endpoint was the composite of COVID-19 hospitalization or all-cause death by day 28.
In an analysis of 562 patients, treatment with remdesivir resulted in an 87% reduction in the risk of COVID-19 hospitalization or all-cause death by day 28 compared with placebo (0.7% vs 5.3%, respectively; P =.008). Remdesivir was also associated with an 81% reduction in the risk of medical visits due to COVID-19 or all-cause death (1.6% vs 8.3% with placebo; P =.002). There were no reported deaths in either treatment arm by day 28.
The most common treatment-emergent adverse events were nausea and headache. There were no new safety signals identified for remdesivir.
“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” said Robert L. Gottlieb, MD, PhD, Cardiologist and Principal Investigator at Baylor University Medical Center and Baylor Scott & White Research Institute.
Remdesivir is currently marketed under the brand name Veklury and is approved for the treatment of COVID-19 in patients aged 12 years and older (weighing at least 40kg) requiring hospitalization.
Veklury® (remdesivir) significantly reduced risk of hospitalization in high-risk patients with COVID-19. News release. Gilead Sciences, Inc. Accessed September 22, 2021. https://www.businesswire.com/news/home/20210922005622/en/Veklury%C2%AE-Remdesivir-Significantly-Reduced-Risk-of-Hospitalization-in-High-Risk-Patients-with-COVID-19.