Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies

• Published in: Clinical infectious diseases 2024-11, Vol.79 (5), p.1182-1189
• Main Authors: Fusco, Dahlene, Malenica, Ivana, Günthard, Huldrych F, Gupta, Samir K, Kurbegov, Dax, Balani, Bindu, Olender, Susan, Aberg, Judith A, Telep, Laura E, Tian, Yuan, Blair, Christiana, Wu, George, Haubrich, Richard H, Wang, Chen-Yu, Chokkalingam, Anand P, Osinusi, Anu O, Wendtner, Clemens-Martin, Gottlieb, Robert L
• Format: Article
• Language: English
• Subjects: Adenosine Monophosphate - analogs & derivatives; Adenosine Monophosphate - therapeutic use; Adult; Aged; Alanine - analogs & derivatives; Alanine - therapeutic use; Antiviral Agents - therapeutic use; Clinical Trials as Topic; COVID-19 - mortality; COVID-19 - therapy; COVID-19 Drug Treatment; Female; Hospitalization; Humans; Male; Middle Aged; Oxygen - therapeutic use; Oxygen Inhalation Therapy; Retrospective Studies; SARS-CoV-2; Standard of Care; Treatment Outcome
• ISSN: 1058-4838; 1537-6591; 1537-6591
• DOI: 10.1093/cid/ciae336

Abstract Background Remdesivir, an RNA-polymerase prodrug inhibitor approved for treatment of coronavirus disease 2019 (COVID-19), shortens recovery time and improves clinical outcomes. This prespecified analysis compared remdesivir plus standard of care (SOC) with SOC alone in adults hospitalized with COVID-19 requiring oxygen support in the early stage of the pandemic. Methods Data for 10-day remdesivir treatment plus SOC from the extension phase of an open-label study (NCT04292899) were compared with real-world, retrospective data on SOC alone (EUPAS34303). Both studies included patients aged ≥18 years hospitalized with severe acute respiratory syndrome coronavirus 2 up to 30 May 2020, with oxygen saturation ≤94% on room air or supplemental oxygen (all forms), and with pulmonary infiltrates. Propensity score weighting was used to balance patient demographics and clinical characteristics across treatment groups. The primary endpoint was time to all-cause mortality or end of study (day 28). Time to discharge, with a 10-day landmark to account for duration of remdesivir treatment, was a secondary endpoint. Results A total of 1974 patients treated with remdesivir plus SOC, and 1426 with SOC alone, were included after weighting. Remdesivir significantly reduced mortality versus SOC (hazard ratio [HR], 0.46; 95% confidence interval, .39–.54). This association was observed at each oxygen support level, with the lowest HR for patients on low-flow oxygen. Remdesivir significantly increased the likelihood of discharge at day 28 versus SOC in the 10-day landmark analysis (HR, 1.64; 95% confidence interval: 1.43–1.87). Conclusions Remdesivir plus early-2020 SOC was associated with a 54% lower mortality risk and shorter hospital stays compared with SOC alone in patients hospitalized with COVID-19 requiring oxygen support. Clinical Trials Registration.  ClinicalTrials.gov NCT04292899 and EUPAS34303. This pooled analysis of clinical and real-world data demonstrated a significant 54% lower mortality risk and 16% increase in discharge at day 28 with remdesivir plus standard of care versus standard of care alone in patients hospitalized with COVID-19 early in the pandemic.