Trial NCT04330690
Publication Ali K, CMAJ (2022) (published paper)
Dates: 2020-08-14 to 2021-04-01
Funding: Public/non profit (Canadian Institutes of Health Research, the Vancouver Coastal Health Research Institute, the Northern Alberta Clinical Trials and Research Centre, Covenant Health Research Centre, the McGill Interdisciplinary Initiative in Infection and Immunity, the St. Joseph’s Health Care Foundation, and the London Health Sciences Foundation)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Canada
Follow-up duration (days): 60
Inclusion criteria
  • Adults
  • laboratory-confirmed SARS-CoV-2 infection
  • admitted to participating hospitals
Exclusion criteria
  • Allergy to study drug
  • anticipated transfer to a nonstudy site
  • expected to not survive beyond 24 hours
  • or already receiving remdesivir at time of enrolment
Interventions
Treatment
Remdesivir
Initial dose: 200 mg intravenously on day 0 - Maintenance dose: 100 mg intravenously on days 1 through 9.
Control
Standard care

Participants
Randomized
participants :
Remdesivir=634
Standard care=648
Characteristics of participants
N= 1282
Mean age : NR
766 males
Severity : Mild: n=125 / Moderate: n=697 / Severe: n=347 Critical: n=112
Number of vaccinated participants: NR
Primary outcome
In the register
All-cause mortality [Time Frame: 29 days]
In the report
In-hospital mortality
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
High
General comment “In addition to the published article, the supplemental appendix and study registry were used in data extraction and risk of bias assessment. Neither the protocol nor the statistical analysis plan was available. There is no change from the trial registration in the remdesivir and control treatments. The registry primary outcome is different from the reported primary outcome (all-cause mortality vs in-hospital mortality [Time Frame: 29 days].The estimated sample size (n=2900 participants) specified in the trial registry corresponds to a 3-arms in a 1:1:1 ratio randomization to either the control arm, consisting of standard supportive care treatment for COVID-19, or remdesivir plus standard supportive care or Interferon-beta-1a plus standard supportive care."