Open Forum Infect Dis . Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

[tetano]

Open Forum Infect Dis


. 2021 May 26;8(7):ofab278.
doi: 10.1093/ofid/ofab278. eCollection 2021 Jul.
Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality


Susan A Olender ¹ , Theresa L Walunas ² , Esteban Martinez ³ , Katherine K Perez ⁴ , Antonella Castagna ⁵ , Su Wang ⁶ , Dax Kurbegov ⁷ , Parag Goyal ⁸ , Diego Ripamonti ⁹ , Bindu Balani ¹⁰ , Francesco G De Rosa ^{11 12 13} , Stéphane De Wit ¹⁴ , Shin-Woo Kim ¹⁵ , George Diaz ¹⁶ , Raffaele Bruno ¹⁷ , Kathleen M Mullane ¹⁸ , David Chien Lye ^{19 20 21} , Robert L Gottlieb ^{22 23} , Richard H Haubrich ²⁴ , Anand P Chokkalingam ²⁴ , George Wu ²⁴ , Helena Diaz-Cuervo ²⁵ , Diana M Brainard ²⁴ , I-Heng Lee ²⁴ , Hao Hu ²⁶ , Lanjia Lin ²⁴ , Anu O Osinusi ²⁴ , Jose I Bernardino ²⁷ , Marta Boffito ²⁸



Affiliations

• PMID: 34282406
• PMCID: PMC8244650
• DOI: 10.1093/ofid/ofab278

Abstract

Background: Remdesivir is approved by the US Food and Drug Administration for the treatment of patients hospitalized with coronavirus disease 2019 (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 (nonremdesivir cohort). Eligible patients, aged ≥18 years, had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-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: A total of 368 (remdesivir) and 1399 (nonremdesivir) patients were included in the matched analysis. The day 14 clinical recovery rate was significantly higher among the remdesivir versus the nonremdesivir cohort (65.2% vs 57.1%; odds ratio [OR], 1.49; 95% confidence interval [CI], 1.16-1.90; P = 0.002). The day 28 mortality rate was significantly lower in the remdesivir cohort versus the nonremdesivir cohort (12.0% vs 16.2%; OR, 0.67; 95% CI, 0.47-.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. These data, taken together, support the use of remdesivir to improve clinical recovery and decrease mortality from SARS-CoV-2 infection.

Keywords: COVID-19; SARS-CoV-2; mortality; remdesivir.