Trial NCT04359901
Publication Branch-Elliman W, PloS one (2022) (published paper)
Dates: 2020-04-10 to 2021-02-03
Funding: Public/non profit (NIH NHLBI; The VISN-1 Clinical Trials Network and the VA Boston Healthcare System)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / USA
Follow-up duration (days): 30
Inclusion criteria
  • Positive SARS-CoV-2 diagnostic test (either PCR or antigen testing) no more than 4 weeks prior to enrollment
  • presence of symptoms of <14 days duration prior to enrollment
  • hospitalization with moderate COVID-19 disease, defined using the Brescia COVID-19 respiratory severity score
Exclusion criteria
  • Critical COVID-19, defined by mechanical ventilation and/or expected death within 24 hours
  • pregnancy
  • enrollment in another interventional clinical trial
  • chronic administration of certain immunosuppressive drugs (e.g., chronic prednisone > 10 mg/day, JAK inhibitors, or immunosuppressive biologics)
Interventions
Treatment
Sarilumab
400 mg subcutaneously single dose (first 9 patients received 200 mg)
Control
Standard care

Participants
Randomized
participants :
Sarilumab=20
Standard care=30
Characteristics of participants
N= 50
Mean age : NR
46 males
Severity : Mild: n=24 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Intubation or death [ Time Frame: within 14 Days of enrollment ] Composite outcome of intubation or death
In the report
A composite of intubation or death within 14 days following randomization
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Not reported
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 registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the article reflects that in the registry. Recruitment to the trial was terminated out of concern for the high probability that rates of intubation or death were higher in the sarilumab arm than the SOC arm, and therefore the study did not achieve its target sample size.