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Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality.
Open Forum Infect Dis. 2021 Jul; 8(7):ofab278.OF

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.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.Northwestern University Feinberg School of Medicine, Illinois, Chicago, USA.Hospital Clínic-IDIBAPS and University of Barcelona, Barcelona, Spain.Department of Pharmacy, Houston Methodist, Houston, Texas, USA.Vita-Salute San Raffaele University, IRCCS San Raffaele, Milan, Italy.Saint Barnabas Medical Center, RWJBarnabas Health Medical Group, Livingston, New Jersey, USA.Sarah Cannon Research Institute, Nashville, Tennessee, USA.Weill Cornell Medicine, New York, New York, USA.ASST Papa Giovanni XXIII, Bergamo, Italy.Hackensack University Medical Center, Hackensack, New Jersey, USA.Department of Medical Sciences, University of Turin, Turin, Italy. City of Health and Sciences, Turin, Italy. Cardinal Massaia Hospital, Asti, Italy.NEAT ID Foundation, CHU Saint Pierre, Université Libre de Bruxelles, Brussels, Belgium.Kyungpook National University Hospital, Republic of Korea.Providence Regional Medical Center Everett, Everett, Washington, USA.Fondazione IRCCS S. Matteo Hospital - University of Pavia, Pavia, Italy.University of Chicago, Chicago, Illinois, USA.National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore. Yong Loo Lin School of Medicine, Singapore. Lee Kong Chian School of Medicine, Singapore.Baylor University Medical Center Dallas, Dallas, Texas, USA. Baylor Scott & White Research Institute, Dallas, Texas, USA.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences, S.L., Madrid, Spain.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences, Ltd, Causeway Bay, Hong Kong.Gilead Sciences Inc., Foster City, California, USA.Gilead Sciences Inc., Foster City, California, USA.Hospital La Paz Institute for Health Research (IdiPAZ) Madrid, Spain.Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34282406

Citation

Olender, Susan A., et al. "Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: an Analysis of 28-Day Mortality." Open Forum Infectious Diseases, vol. 8, no. 7, 2021, pp. ofab278.
Olender SA, Walunas TL, Martinez E, et al. Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality. Open Forum Infect Dis. 2021;8(7):ofab278.
Olender, S. A., Walunas, T. L., Martinez, E., Perez, K. K., Castagna, A., Wang, S., Kurbegov, D., Goyal, P., Ripamonti, D., Balani, B., De Rosa, F. G., De Wit, S., Kim, S. W., Diaz, G., Bruno, R., Mullane, K. M., Lye, D. C., Gottlieb, R. L., Haubrich, R. H., ... Boffito, M. (2021). Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality. Open Forum Infectious Diseases, 8(7), ofab278. https://doi.org/10.1093/ofid/ofab278
Olender SA, et al. Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: an Analysis of 28-Day Mortality. Open Forum Infect Dis. 2021;8(7):ofab278. PubMed PMID: 34282406.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Remdesivir Versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality. AU - Olender,Susan A, AU - Walunas,Theresa L, AU - Martinez,Esteban, AU - Perez,Katherine K, AU - Castagna,Antonella, AU - Wang,Su, AU - Kurbegov,Dax, AU - Goyal,Parag, AU - Ripamonti,Diego, AU - Balani,Bindu, AU - De Rosa,Francesco G, AU - De Wit,Stéphane, AU - Kim,Shin-Woo, AU - Diaz,George, AU - Bruno,Raffaele, AU - Mullane,Kathleen M, AU - Lye,David Chien, AU - Gottlieb,Robert L, AU - Haubrich,Richard H, AU - Chokkalingam,Anand P, AU - Wu,George, AU - Diaz-Cuervo,Helena, AU - Brainard,Diana M, AU - Lee,I-Heng, AU - Hu,Hao, AU - Lin,Lanjia, AU - Osinusi,Anu O, AU - Bernardino,Jose I, AU - Boffito,Marta, Y1 - 2021/05/26/ PY - 2021/04/15/received PY - 2021/05/24/accepted PY - 2021/7/20/entrez PY - 2021/7/21/pubmed PY - 2021/7/21/medline KW - COVID-19 KW - SARS-CoV-2 KW - mortality KW - remdesivir SP - ofab278 EP - ofab278 JF - Open forum infectious diseases JO - Open Forum Infect Dis VL - 8 IS - 7 N2 - 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. SN - 2328-8957 UR - https://www.unboundmedicine.com/medline/citation/34282406/Remdesivir_Versus_Standard-of-Care_for_Severe_Coronavirus_Disease_2019_Infection:_An_Analysis_of_28-Day_Mortality. L2 - https://academic.oup.com/ofid/article-lookup/doi/10.1093/ofid/ofab278 DB - PRIME DP - Unbound Medicine ER -
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