Dataset Information

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

ABSTRACT:

Background

The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems.

Methods

We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation.

Results

Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir (n = 634) or standard of care (n = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care (p = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups.

Interpretation

Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation. Trial registration: ClinicalTrials.gov, no. NCT04330690.

SUBMITTER: Ali K

PROVIDER: S-EPMC8863204 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

Ali Karim K Azher Tanweer T Baqi Mahin M Binnie Alexandra A Borgia Sergio S Carrier François M FM Cavayas Yiorgos Alexandroa YA Chagnon Nicolas N Cheng Matthew P MP Conly John J Costiniuk Cecilia C Daley Peter P Daneman Nick N Douglas Josh J Downey Catarina C Duan Erick E Duceppe Emmanuelle E Durand Madeleine M English Shane S Farjou George G Fera Evradiki E Fontela Patricia P Fowler Rob R Fralick Michael M Geagea Anna A Grant Jennifer J Harrison Luke B LB Havey Thomas T Hoang Holly H Kelly Lauren E LE Keynan Yoav Y Khwaja Kosar K Klein Gail G Klein Marina M Kolan Christophe C Kronfli Nadine N Lamontagne Francois F Lau Rob R Fralick Michael M Lee Todd C TC Lee Nelson N Lim Rachel R Longo Sarah S Lostun Alexandra A MacIntyre Erika E Malhamé Isabelle I Mangof Kathryn K McGuinty Marlee M Mergler Sonya S Munan Matthew P MP Murthy Srinivas S O'Neil Conar C Ovakim Daniel D Papenburg Jesse J Parhar Ken K Parvathy Seema Nair SN Patel Chandni C Perez-Patrigeon Santiago S Pinto Ruxandra R Rajakumaran Subitha S Rishu Asgar A Roba-Oshin Malaika M Rushton Moira M Saleem Mariam M Salvadori Marina M Scherr Kim K Schwartz Kevin K Semret Makeda M Silverman Michael M Singh Ameeta A Sligl Wendy W Smith Stephanie S Somayaji Ranjani R Tan Darrell H S DHS Tobin Siobhan S Todd Meaghan M Tran Tuong-Vi TV Tremblay Alain A Tsang Jennifer J Turgeon Alexis A Vakil Erik E Weatherald Jason J Yansouni Cedric C Zarychanski Ryan R

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20220119 7

<h4>Background</h4>The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, ...[more]

PMID: 35045989

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Dataset Information

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

Background

Methods

Results

Interpretation

Publications

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

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