Trial NCT04501952; EudraCT 2020-003510-12.
Publication Gottlieb RL, N Engl J Med (2021) (published paper)
Dates: 2020-09-18 to 2021-04-08
Funding: Private (Gilead Sciences, Inc.)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Denmark, Spain, UK, USA
Follow-up duration (days): 28
Inclusion criteria
  • 12 years of age or older
  • At least one preexisting risk factor for progression to severe Covid-19 or 60 years of age or older, regardless of whether they had other risk factors - risk factors included hypertension, cardiovascular or cerebrovascular disease, diabetes mellitus, obesity (a body-mass index of ≥30), immune compromise, chronic mild or moderate kidney disease, chronic liver disease, chronic lung disease, current cancer, or sickle cell disease
  • At least one ongoing symptom consistent with Covid-19, with onset of the first symptom within 7 days before randomization
  • SARS-CoV-2 infection confirmed by a molecular diagnostic assay within 4 days before screening
Exclusion criteria
  • Receiving or were expected to receive supplemental oxygen or hospital care at the time of screening
  • Had a previous hospitalization for Covid-19
  • Had previously received treatment for Covid-19 (including investigational agents)
  • Had received a SARS-CoV-2 vaccine
Interventions
Treatment
Remdesivir
Initial dose: 200 mg intravenously on day 1 - Maintenance dose: 100 mg intravenously on days 2 & 3
Control
Placebo

Participants
Randomized
participants :
Remdesivir=292
Placebo=292
Characteristics of participants
N= 584
Mean age : NR
293 males
Severity : Mild: n= 584/ Asymptomatic: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
1) Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28 [ Time Frame: Randomization up to Day 28 ]; 2) Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to last dose date (maximum: 3 days) plus 30 days ]
In the report
1) A composite of hospitalization related to Covid-19 (as deter- mined by site investigators, who were unaware of trial-group assignments, and defined as ≥24 hours of acute care) or death from any cause by day 28; 2) adverse events.
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 published article, the prospective trial registries, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary efficacy and safety outcomes in the article reflect those in the registry and protocol. Recruitment was terminated due to enrollment feasibility and changing needs of non-hospitalized participants and thus the trial (n = 584) did not achieve its target sample size (n = 1264).
This study was updated on November 3rd, 2022 with data extracted from the registry.