Trial NCT04315948, EudraCT2020-000936-23
Publication DisCoVeRy - Ader F, Lancet Infect Dis (2022) (published paper)
Dates: 2020-03-22 to 2021-01-21
Funding: Public/non profit (European Union Commission, French Ministry of Health, DIM One Health Île-de France, REACTing, Fonds Erasme-COVID-ULB, Belgian Health Care Knowledge Centre (KCE))
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Austria, Belgium, France, Luxembourg, Portugal
Follow-up duration (days): 90
Inclusion criteria
  • Hospitalised participants ≥18 years of age
  • laboratory-confirmed SARS-CoV-2 infection
  • illness of any duration
  • at least one of the following: clinical assessment (evidence of rales/crackles on exam) and SpO2 ≤ 94% on room air, or requirement of supplemental oxygen, high flow oxygen devices, non-invasive ventilation and/or mechanical ventilation
  • women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study
  • written informed consent
Exclusion criteria
  • Liver enzymes (ALT/AST) > 5 times the upper limit of normal
  • stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30 mL/min)
  • anticipated transfer to another hospital which is not a study site within 72 hours
  • contraindication to any study medication including allergy
  • treated with one of the evaluated antivirals in the in the past 29 days or used ribavirin in the 29 days and/or concomitantly to randomisation
  • pregnant or breast-feeding women
Interventions
Treatment
Remdesivir
Initial dose: 200 mg IV on the first day -Maintenance dose: 100 mg IV once a day for 5-9 days
Control
Standard care

Participants
Randomized
participants :
Standard care=428
Remdesivir=429
Characteristics of participants
N= 857
Mean age : NR
588 males
Severity : Mild: n=15 / Moderate: n=482 / Severe: n=192 Critical: n=154
Number of vaccinated participants: 0
Primary outcome
In the register
Percentage of subjects reporting each severity rating on a 7-point ordinal scale [ Time Frame: Day 15 ]
In the report
Clinical status at day 15 as measured on the 7-point ordinal scale of the WHO
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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
Some concerns
General comment In addition to the pre-print/published article, the published protocol, supplementary appendices, prospective online trial registries and data gained from contact with authors were used in data analysis and risk of bias assessment. The pre-print reported on an interim analysis for the remdesivir intervention arm of a multiple-arm platform study (DisCoVeRy, an add-on trial to the WHO Solidarity consortium) that was terminated early due to futility. Consequently, the planned sample size was not achieved and long-term outcomes were not reported. Other than that, there were no substantial changes to procedures, population, or interventions. The outcome WHO Score 7 or above includes participants with events within 28 days rather than at 28 days. Mortality at day 28 was reported but not extracted due to overlapping patient population with Pan, N Engl J Med, 2020.
On 12th of July, 2021, this study was updated based on updated pre-print.
On 6th of October, 2021, this study was updated based on the published article.
On 16th of November, 2021, this study was updated based on data from contact with authors.
On 14th of April, 2022, this study was updated based on the preprint reporting on the final results.
On the 18th of November, 2022, this study was updated with the final results extracted from the publication.