The RECOVERY trial is an investigator-initiated, streamlined, individually randomised, controlled, open-label, platform trial to evaluate the effects of potential treatments in patients hospitalised with COVID-19. Details of the trial design and results for other possible treatments (dexamethasone,7 (link) hydroxychloroquine,21 (link) lopinavir–ritonavir,22 (link) azithromycin,23 (link) tocilizumab,9 (link) and convalescent plasma24 (link)) have been published previously. The trial is underway at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal (appendix pp 3–25 ). The trial is supported by the National Institute for Health Research Clinical Research Network, and is coordinated by the Nuffield Department of Population Health (University of Oxford, Oxford, UK), the trial sponsor. The trial was done in accordance with the principles of the International Conference on Harmonisation–Good Clinical Practice guidelines and approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Cambridge East Research Ethics Committee (20/EE/0101). The protocol, statistical analysis plan, and additional information are available online .
Patients admitted to hospital were eligible for the study if they had clinically suspected or laboratory confirmed SARS-CoV-2 infection and 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. Children and pregnant women were not eligible to receive colchicine. Patients with severe liver impairment, significant cytopaenia, concomitant use of strong CYP3A4 (eg, clarithromycin, erythromycin, systemic azole antifungal, and HIV protease inhibitor) or P-glycoprotein inhibitors (eg, ciclosporin, verapamil, and quinidine), or hypersensitivity to lactose were excluded from the colchicine comparison (appendix p 81 ). Written informed consent was obtained from all patients, or a legal representative if patients were too unwell or unable to provide consent.
Patients admitted to hospital were eligible for the study if they had clinically suspected or laboratory confirmed SARS-CoV-2 infection and 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. Children and pregnant women were not eligible to receive colchicine. Patients with severe liver impairment, significant cytopaenia, concomitant use of strong CYP3A4 (eg, clarithromycin, erythromycin, systemic azole antifungal, and HIV protease inhibitor) or P-glycoprotein inhibitors (eg, ciclosporin, verapamil, and quinidine), or hypersensitivity to lactose were excluded from the colchicine comparison (
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