Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial
et al., Canadian Medical Association Journal, doi:10.1503/cmaj.211698, CATCO, NCT04330690, Jan 2022
RCT 1,282 hospitalized patients in Canada showing lower mechanical ventilation with remdesivir treatment, but no significant difference for mortality.
Gérard, Zhou, Wu, Kamo, Choi, Kim show increased risk of acute kidney injury, Leo, Briciu, Muntean, Petrov show increased risk of liver injury, and Negru, Cheng, Mohammed show increased risk of cardiac disorders with remdesivir.
Remdesivir efficacy disappears with longer
followup. Mixed-effects meta-regression of efficacy as a function of
followup duration across all remdesivir studies shows decreasing efficacy with
longer followup14. This may reflect
antiviral efficacy being offset by serious adverse effects of treatment.
|
risk of death, 12.0% lower, RR 0.88, p = 0.21, treatment 127 of 634 (20.0%), control 152 of 647 (23.5%), NNT 29, day 60.
|
|
risk of death, 17.0% lower, RR 0.83, p = 0.09, treatment 117 of 634 (18.5%), control 145 of 647 (22.4%), NNT 25, in hospital.
|
|
risk of death, 20.6% lower, RR 0.79, p = 0.59, treatment 14 of 634 (2.2%), control 18 of 647 (2.8%), NNT 174, day 15.
|
|
risk of mechanical ventilation, 47.0% lower, RR 0.53, p < 0.001, treatment 46 of 634 (7.3%), control 89 of 647 (13.8%), NNT 15, day 60.
|
|
risk of no recovery, 9.0% lower, RR 0.91, p = 0.41, treatment 634, control 647, clinical status, day 60.
|
|
hospitalization time, 11.1% higher, relative time 1.11, p = 0.04, treatment median 10.0 IQR 12.0 n=634, control median 9.0 IQR 11.0 n=647.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
1.
Gérard et al., Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database, Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2145.
2.
Zhou et al., Acute Kidney Injury and Drugs Prescribed for COVID-19 in Diabetes Patients: A Real-World Disproportionality Analysis, Frontiers in Pharmacology, doi:10.3389/fphar.2022.833679.
3.
Wu et al., Acute Kidney Injury Associated With Remdesivir: A Comprehensive Pharmacovigilance Analysis of COVID-19 Reports in FAERS, Frontiers in Pharmacology, doi:10.3389/fphar.2022.692828.
4.
Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.
5.
Choi et al., Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study, The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00353-0.
6.
Kim et al., Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study, Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043.
7.
Leo et al., Hepatocellular liver injury in hospitalized patients affected by COVID-19: Presence of different risk factors at different time points, Digestive and Liver Disease, doi:10.1016/j.dld.2021.12.014.
8.
Briciu et al., Evolving Clinical Manifestations and Outcomes in COVID-19 Patients: A Comparative Analysis of SARS-CoV-2 Variant Waves in a Romanian Hospital Setting, Pathogens, doi:10.3390/pathogens12121453.
9.
Muntean et al., Effects of COVID-19 on the Liver and Mortality in Patients with SARS-CoV-2 Pneumonia Caused by Delta and Non-Delta Variants: An Analysis in a Single Centre, Pharmaceuticals, doi:10.3390/ph17010003.
10.
Petrov et al., The Effect of Potentially Hepatotoxic Medicinal Products on Alanine Transaminase Levels in COVID-19 Patients: A Case–Control Study, Safety and Risk of Pharmacotherapy, doi:10.30895/2312-7821-2025-458.
11.
Negru et al., Comparative Pharmacovigilance Analysis of Approved and Repurposed Antivirals for COVID-19: Insights from EudraVigilance Data, Biomedicines, doi:10.3390/biomedicines13061387.
12.
Cheng et al., Cardiovascular Safety of COVID-19 Treatments: A Disproportionality Analysis of Adverse Event Reports from the WHO VigiBase, Infectious Diseases and Therapy, doi:10.1007/s40121-025-01225-z.
Ali et al., 19 Jan 2022, Randomized Controlled Trial, Canada, peer-reviewed, 85 authors, average treatment delay 8.0 days, trial NCT04330690 (history) (CATCO).
Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial
Canadian Medical Association Journal, doi:10.1503/cmaj.211698
T he role of remdesivir in treating patients in hospital with COVID-19 remains ill defined. 1 Remdesivir, a repurposed antiviral medication, has full or emergency approval from a number of regulators -including Health Canada -for the treatment of COVID-19, based on clinical trial data documenting a benefit on improving time to recovery. 2 An interim report of the larger World Health Organization (WHO) Solidarity trial showed no difference regarding mortality or need for mechanical ventilation, with a number of smaller trials being inconclusive on these important outcomes. [3] [4] [5] [6] Recommendations of clinical guidelines are mixed, with some recommending remdesivir as standard of care, and others weakly recommending against. 7, 8 Its impact on other clinical outcomes, including resource utilization and post-hospital stay outcomes, has not been fully defined, and there remains a possibility of an important treatment effect, particularly in certain groups of patients. 9
Research Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial Canadian Treatments for COVID-19 (CATCO)*; for the Association of Medical Microbiology and Infectious Disease Canada (AMMI) Clinical Research Network and the Canadian Critical Care Trials Group
Authors: Karim Ali, Tanweer Azher, Mahin Baqi, Alexandra Binnie, Competing interests: Alexandra Binnie reports receiving research grants from the Canadian Institutes of Health Research (CIHR) and the Physicians Services Incorporated Foundation. Sergio Borgia reports receiving honoraria from Gilead Sciences and GSK. Yiorgos Alexandros Cavayas reports receiving a grant from CIHR. Matthew Cheng reports receiving grants from the McGill Interdisciplinary Initiative in Infection and Immunity and from CIHR, during the conduct of the study (payments made to the institution). Dr. Cheng also reports receiving personal fees from AstraZeneca, outside the submitted work; and from Nplex Biosciences and GEn1E lifesciences (in the form of stock options for being a member of the scientific advisory board) outside the submitted work. Dr. Cheng co-founded Kanvas Biosicences and owns equity in the company, and reports 3 patents pending. Ameeta Singh reports receiving consulting fees from Gilead for membership of an advisory board. Ranjani Somayaji reports receiving contract research funding from Sunnybrook Research Institute, University of Calgary and Calgary Health Foundation, and clinical research funding from CIHR and the Cystic Fibrosis Foundation. Dr. Somayaji also reports participation on an oncovir data monitoring safety board. Darrell Tan reports receiving grants from AbbVie (in-kind drug only) and Gilead (inkind drug and grants to institution), and a contract between GSK and the..
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Late treatment
is less effective
is less effective
