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. 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

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

Susan A Olender et al. Open Forum Infect Dis. .

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.

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Figures

Figure 1.
Figure 1.
Primary endpoint analyses: (A) odds ratio for day 14 clinical recovery; (B) odds ratio for day 28 all-cause mortality. P value, odds ratio, and 95% confidence interval (CI) were based on the generalized estimating equation logistic regression with propensity-matched sets considered as clusters. Numbers for the nonremdesivir cohort are based on weighted statistics.
Figure 2.
Figure 2.
Subgroup analysis of patients categorized according to oxygen support status required at baseline (based on propensity score matching) for (A) day 14 recovery and (B) day 28 all-cause mortality. P value, odds ratio, and 95% confidence interval (CI) were based on the generalized estimating equation logistic regression with matched sets considered as clusters. Numbers for the nonremdesivir cohort are based on weighted statistics.
Figure 3.
Figure 3.
Multivariable analysis of the odds ratio for day 28 all-cause mortality using generalized estimating equation logistic regression model. *Medications potentially active against coronavirus disease 2019. CI, confidence interval; COPD, chronic obstructive pulmonary disease.
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