Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality

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 compa...

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Main Authors: 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., Lye, David C., 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
Other Authors: Lee Kong Chian School of Medicine (LKCMedicine)
Format: Article
Language:English
Published: 2022
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Online Access:https://hdl.handle.net/10356/154077
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spelling sg-ntu-dr.10356-1540772023-03-05T16:51:40Z 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. Lye, David C. 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 Lee Kong Chian School of Medicine (LKCMedicine) Tan Tock Seng Hospital Yong Loo Lin School of Medicine Science::Medicine Mortality Remdesivir 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. Published version This study was funded by Gilead Sciences, Inc. 2022-05-24T08:13:59Z 2022-05-24T08:13:59Z 2021 Journal Article 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., 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://dx.doi.org/10.1093/ofid/ofab278 2328-8957 https://hdl.handle.net/10356/154077 10.1093/ofid/ofab278 34282406 2-s2.0-85112539569 7 8 ofab278 en Open Forum Infectious Diseases © The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/ by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com DOI: 10.1093/ofid/ofab278. application/pdf
institution Nanyang Technological University
building NTU Library
continent Asia
country Singapore
Singapore
content_provider NTU Library
collection DR-NTU
language English
topic Science::Medicine
Mortality
Remdesivir
spellingShingle Science::Medicine
Mortality
Remdesivir
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.
Lye, David C.
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
Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
description 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.
author2 Lee Kong Chian School of Medicine (LKCMedicine)
author_facet Lee Kong Chian School of Medicine (LKCMedicine)
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.
Lye, David C.
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
format Article
author 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.
Lye, David C.
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
author_sort Olender, Susan A.
title Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
title_short Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
title_full Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
title_fullStr Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
title_full_unstemmed Remdesivir versus standard-of-care for severe Coronavirus disease 2019 Infection: an analysis of 28-day mortality
title_sort remdesivir versus standard-of-care for severe coronavirus disease 2019 infection: an analysis of 28-day mortality
publishDate 2022
url https://hdl.handle.net/10356/154077
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