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

COVID-19 SARS-CoV-2 mortality remdesivir

Journal

Open forum infectious diseases
ISSN: 2328-8957
Titre abrégé: Open Forum Infect Dis
Pays: United States
ID NLM: 101637045

Informations de publication

Date de publication:
Jul 2021
Historique:
received: 15 04 2021
accepted: 24 05 2021
entrez: 20 7 2021
pubmed: 21 7 2021
medline: 21 7 2021
Statut: epublish

Résumé

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. 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). 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; 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.

Sections du résumé

BACKGROUND 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 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 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;
CONCLUSIONS 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.

Identifiants

pubmed: 34282406
doi: 10.1093/ofid/ofab278
pii: ofab278
pmc: PMC8244650
doi:

Types de publication

Journal Article

Langues

eng

Pagination

ofab278

Subventions

Organisme : NCATS NIH HHS
ID : UL1 TR001422
Pays : United States

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Références

Clin Infect Dis. 2020 Jul 24;:
pubmed: 32706859
JAMA Netw Open. 2020 Dec 1;3(12):e2026881
pubmed: 33275153
Mol Cell. 2021 Apr 1;81(7):1548-1552.e4
pubmed: 33631104
Eur Respir Rev. 2020 Oct 5;29(157):
pubmed: 33020069
Clin Infect Dis. 2020 Dec 14;:
pubmed: 33315065
Infect Dis Rep. 2020 Mar 16;12(1):8543
pubmed: 32218915
N Engl J Med. 2020 Jun 11;382(24):2327-2336
pubmed: 32275812
N Engl J Med. 2021 Feb 25;384(8):693-704
pubmed: 32678530
N Engl J Med. 2021 Feb 11;384(6):497-511
pubmed: 33264556
JAMA. 2020 Aug 25;324(8):782-793
pubmed: 32648899
N Engl J Med. 2020 May 7;382(19):1787-1799
pubmed: 32187464
JAMA. 2020 Sep 15;324(11):1048-1057
pubmed: 32821939
JAMA. 2020 May 26;323(20):2052-2059
pubmed: 32320003
Lancet. 2020 Mar 28;395(10229):1054-1062
pubmed: 32171076
Lancet. 2020 May 16;395(10236):1569-1578
pubmed: 32423584
Turk J Phys Med Rehabil. 2020 May 12;66(2):104-120
pubmed: 32760887
N Engl J Med. 2020 Nov 5;383(19):1827-1837
pubmed: 32459919
Pharmacol Res. 2020 Aug;158:104899
pubmed: 32407959
N Engl J Med. 2021 Feb 11;384(6):576-577
pubmed: 33264557
J Gen Intern Med. 2020 Dec;35(12):3753-3755
pubmed: 32989715
Pol Arch Intern Med. 2021 Jan 29;131(1):103-110
pubmed: 33382547
Cell Rep. 2020 Jul 21;32(3):107940
pubmed: 32668216
N Engl J Med. 2020 Nov 5;383(19):1813-1826
pubmed: 32445440
Lancet. 2020 May 16;395(10236):1525-1527
pubmed: 32423580
Anaesthesist. 2020 Nov 27;:
pubmed: 33245382
J Biol Chem. 2020 May 15;295(20):6785-6797
pubmed: 32284326

Auteurs

Susan A Olender (SA)

Division of Infectious Diseases, Department of Internal Medicine, Columbia University Irving Medical Center, New York, New York, USA.

Theresa L Walunas (TL)

Northwestern University Feinberg School of Medicine, Illinois, Chicago, USA.

Esteban Martinez (E)

Hospital Clínic-IDIBAPS and University of Barcelona, Barcelona, Spain.

Katherine K Perez (KK)

Department of Pharmacy, Houston Methodist, Houston, Texas, USA.

Antonella Castagna (A)

Vita-Salute San Raffaele University, IRCCS San Raffaele, Milan, Italy.

Su Wang (S)

Saint Barnabas Medical Center, RWJBarnabas Health Medical Group, Livingston, New Jersey, USA.

Dax Kurbegov (D)

Sarah Cannon Research Institute, Nashville, Tennessee, USA.

Parag Goyal (P)

Weill Cornell Medicine, New York, New York, USA.

Diego Ripamonti (D)

ASST Papa Giovanni XXIII, Bergamo, Italy.

Bindu Balani (B)

Hackensack University Medical Center, Hackensack, New Jersey, USA.

Francesco G De Rosa (FG)

Department of Medical Sciences, University of Turin, Turin, Italy.
City of Health and Sciences, Turin, Italy.
Cardinal Massaia Hospital, Asti, Italy.

Stéphane De Wit (S)

NEAT ID Foundation, CHU Saint Pierre, Université Libre de Bruxelles, Brussels, Belgium.

Shin-Woo Kim (SW)

Kyungpook National University Hospital, Republic of Korea.

George Diaz (G)

Providence Regional Medical Center Everett, Everett, Washington, USA.

Raffaele Bruno (R)

Fondazione IRCCS S. Matteo Hospital - University of Pavia, Pavia, Italy.

Kathleen M Mullane (KM)

University of Chicago, Chicago, Illinois, USA.

David Chien Lye (DC)

National Centre for Infectious Diseases, Tan Tock Seng Hospital, Singapore.
Yong Loo Lin School of Medicine, Singapore.
Lee Kong Chian School of Medicine, Singapore.

Robert L Gottlieb (RL)

Baylor University Medical Center Dallas, Dallas, Texas, USA.
Baylor Scott & White Research Institute, Dallas, Texas, USA.

Richard H Haubrich (RH)

Gilead Sciences Inc., Foster City, California, USA.

Anand P Chokkalingam (AP)

Gilead Sciences Inc., Foster City, California, USA.

George Wu (G)

Gilead Sciences Inc., Foster City, California, USA.

Helena Diaz-Cuervo (H)

Gilead Sciences, S.L., Madrid, Spain.

Diana M Brainard (DM)

Gilead Sciences Inc., Foster City, California, USA.

I-Heng Lee (IH)

Gilead Sciences Inc., Foster City, California, USA.

Hao Hu (H)

Gilead Sciences, Ltd, Causeway Bay, Hong Kong.

Lanjia Lin (L)

Gilead Sciences Inc., Foster City, California, USA.

Anu O Osinusi (AO)

Gilead Sciences Inc., Foster City, California, USA.

Jose I Bernardino (JI)

Hospital La Paz Institute for Health Research (IdiPAZ) Madrid, Spain.

Marta Boffito (M)

Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom.

Classifications MeSH