The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial is an investigator-initiated, 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, hydroxychloroquine, lopinavir–ritonavir, azithromycin, tocilizumab, convalescent plasma, colchicine, aspirin, and casirivimab plus imdevimab) have been published previously.3 (link), 5 (link), 18 (link), 19 (link), 20 (link), 21 (link), 22 (link), 23 (link), 24 (link) The trial is underway at 177 hospital organisations in the UK supported by the National Institute for Health Research Clinical Research Network (appendix pp 3–27 ). Of these, 159 UK hospitals enrolled participants in the evaluation of baricitinib. The trial is coordinated by the Nuffield Department of Population Health at the University of Oxford (Oxford, UK), the trial sponsor. The trial is 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 and the Cambridge East Research Ethics Committee (reference 20/EE/0101). The protocol and statistical analysis plan are available in the appendix (pp 68–145) with additional information available on the study website.
Patients aged at least 2 years 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 substantial risk if they were to participate in the trial. Patients were ineligible for the comparison of baricitinib versus usual care if younger than 2 years, had estimated glomerular filtration rate (eGFR) of less than 15 mL/min per 1·73 m2 or were on dialysis or haemofiltration, had a neutrophil count of less than 0·5 × 109 per L, had evidence of active tuberculosis infection, or were pregnant or breastfeeding. Written informed consent was obtained from all patients, or a legal representative if patients were too unwell or unable to provide consent.
Patients aged at least 2 years 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 substantial risk if they were to participate in the trial. Patients were ineligible for the comparison of baricitinib versus usual care if younger than 2 years, had estimated glomerular filtration rate (eGFR) of less than 15 mL/min per 1·73 m2 or were on dialysis or haemofiltration, had a neutrophil count of less than 0·5 × 109 per L, had evidence of active tuberculosis infection, or were pregnant or breastfeeding. Written informed consent was obtained from all patients, or a legal representative if patients were too unwell or unable to provide consent.
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