Remdesivir versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

Olender, Susan A; Walunas, Theresa L; Martinez, Esteban; Perez, Katherine K; Castagna, Antonella; Wang, Su; Kurbegov, Dax; Goyal, Parag; Ripamonti, Diego; Balani, Bindu; De Rosa, Francesco G; De Wit, Stéphane; Kim, Shin-Woo; Diaz, George; Bruno, Raffaele; Mullane, Kathleen M; Chien Lye, David; Gottlieb, Robert L; Haubrich, Richard H; Chokkalingam, Anand P; Wu, George; Diaz-Cuervo, Helena; Brainard, Diana M; Lee, I-Heng; Hu, Hao; Lin, Lanjia; Osinusi, Anu O; Bernardino, Jose I; Boffito, Marta

BACKGROUND: Remdesivir is FDA approved for the treatment of hospitalized patients with COVID-19 and has been shown to shorten time to recovery and improve clinical outcomes in randomized trials. METHODS: This was the final day 28 comparative analysis of data from a phase 3, randomized, open-label study comparing 2 remdesivir regimens (5 vs 10 days, combined for this analysis [remdesivir cohort]) and a real-world retrospective longitudinal cohort study of patients receiving standard-of-care treatment (non-remdesivir cohort). Eligible patients, aged ≥18 years, had confirmed SARSCoV-2, oxygen saturation ≤94% on room air or required supplemental oxygen, with pulmonary infiltrates. Propensity score matching (up to 1:10 ratio) was used to ensure comparable populations. We assessed day 14 clinical recovery (determined using a 7-point ordinal scale) and day 28 all-cause mortality (coprimary endpoints). RESULTS: Altogether, 368 (remdesivir) and 1399 (non-remdesivir) patients were included in the matched analysis. The day 14 clinical recovery rate was significantly higher among the remdesivir versus the non-remdesivir cohort (65.2% vs 57.1%; OR 1.49, 95% CI 1.16–1.90; P = .002). The day 28 mortality rate was significantly lower in the remdesivir cohort versus the non-remdesivir cohort (12.0% vs 16.2%; OR 0.67, 95% CI 0.47–0.95; P = .03). CONCLUSIONS: Remdesivir was associated with significantly higher rates of day 14 clinical recovery, and lower day 28 mortality, compared with standard-of-care treatment in hospitalized patients with COVID-19. Collectively, these data support the use of remdesivir to improve clinical recovery and decrease mortality from SARS-CoV-2 infection.