Trial NCT04381936; EudraCT2020-001113-21; ISRCTN50189673
Publication RECOVERY - Horby P, Lancet (2022) (published paper)
Dates: 2021-02-02 to 2021-12-29
Funding: Public/non profit (UK Research and Innovation (Medical Research Council) and National Institute of Health Research)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK
Follow-up duration (days): 28
Inclusion criteria
  • Patients aged at least 2 years
  • Admitted to hospital
  • Clinically suspected or laboratory confirmed SARS-CoV-2 infection
  • No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial
  • Written informed consent from all patients, or a legal representative if patients were too unwell or unable to provide consent
Exclusion criteria
  • Aged <2 years
  • eGFR <15 mL/min/1.73m2 or on dialysis or haemofiltration
  • Neutrophil count <0.5 × 109/L
  • Evidence of active TB infection
  • Pregnant or breastfeeding
Interventions
Treatment
Baricitinib
4 mg orally per day for 10 days or discharge (reduced for patients with impaired renal function or children <9 years)
Control
Standard care

Participants
Randomized
participants :
Baricitinib=4148
Standard care=4008
Characteristics of participants
N= 8156
Mean age : NR
5378 males
Severity : Mild: n=465 / Moderate: n=5513 / Severe: n=1927 Critical: n=251
Number of vaccinated participants: 1755
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
28-day all-cause mortality
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 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 the primary outcome in the registry and protocol. Recruitment to the trial was terminated after a planned interim analysis on the decision of the Trial Steering Committee when a statistically significant reduction in all-cause mortality was detected.
This study was updated on August 18th, 2022 with data extracted from the published report.