Trial NCT04381936 ; ISRCTN50189673
Publication RECOVERY (COL) - Horby P, Lancet Respir Med (2021) (published paper)
Dates: 2020-11-27 to 2021-03-04
Funding: Mixed (UK Research and Innovation (Medical Research Council); National Institute of Health Research; Wellcome Trust;. Bill and Melinda Gates Foundation; Foreign, Commonwealth and Development Office; Health Data Research UK; Combiphar (drug donation))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / UK, Indonesia, Nepal
Follow-up duration (days): 28
Inclusion criteria
  • 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.
Exclusion criteria
  • Children and pregnant women
  • patients with severe liver impairment, significant cytopaenia, concomitant use of strong CYP3A4 or P-glycoprotein inhibitors, or hypersensitivity to lactose.
Interventions
Treatment
Colchicine
Initial dose: 1 mg after randomization and 500 mcg 12 hours later - Maintenance dose: 500 mcg twice daily orally or by nasogastric tube for 10 days or until discharge.
Control
Standard care

Participants
Randomized
participants :
Standard care=5730
Colchicine=5610
Characteristics of participants
N= 11340
Mean age : NR
7909 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=3034 Critical: n=529
Number of vaccinated participants: NR
Primary outcome
In the register
All-cause mortality [ Time Frame: Within 28 days after randomisation ]
In the report
28-day mortality
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:
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 trial registries, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the registry, protocol or statistical analysis plan on procedures, interventions or outcomes. Whereas in the trial registry (clinicaltrials.gov) colchicine was only allowed in women ≥55 years old, in the report only pregnant women were disallowed from the treatment. Recruitment was stopped on the advice of the independent data monitoring committee following a routine interim analysis that revealed there was no convincing evidence that further recruitment to the colchicine comparison would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup. On October 20th, he extraction and risk of bias were updated with the information from the published article.