Abstract: Original research Colchicine and high-­intensity rosuvastatin in the treatment of non-­ critically ill patients hospitalised with COVID-­19: a randomised clinical trial Tayyab Shah,1,2 Marianne McCarthy,1,2 Irem Nasir,2,3 Herb Archer,2,3 Elio Ragheb,1 Jonathan Kluger,1 Nitu Kashyap,1,2 Carlos Paredes,1,2 Prashant Patel,2,4 Jing Lu,1 Prakash Kandel,2,4 Christopher Song,2,4 Mustafa Khan,2,3 Haocheng Huang,1 Faheem Ul Haq,2,5 Rami Ahmad,1,2 Christopher Howes,2,3 Brian Cambi,2,4 Gilead Lancaster,2,5 Michael Cleman,2,3 Charles Dela Cruz,1,2 Helen Parise,1 Alexandra Lansky ‍ ‍1,2 To cite: Shah T, McCarthy M, Nasir I, et al. Colchicine and high-­intensity rosuvastatin in the treatment of non-­critically ill patients hospitalised with COVID-­19: a randomised clinical trial. BMJ Open 2023;13:e067910. doi:10.1136/ bmjopen-2022-067910 ► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (http://dx.doi.org/10.1136/​ bmjopen-2022-067910). Received 31 August 2022 Accepted 16 January 2023 © Author(s) (or their employer(s)) 2023. Re-­use permitted under CC BY-­NC. No commercial re-­use. See rights and permissions. Published by BMJ. 1 Yale School of Medicine, New Haven, Connecticut, USA 2 Yale New Haven Health System, New Haven, Connecticut, USA 3 Greenwich Hospital, Greenwich, CT, USA 4 Lawrence & Memorial Hospital, New London, CT, USA 5 Bridgeport Hospital, Bridgeport, CT, USA Correspondence to Dr Alexandra Lansky; a​ lexandra.​lansky@y​ ale.​edu ABSTRACT Objective To evaluate the effect of colchicine and high-­ intensity rosuvastatin in addition to standard of care on the progression of COVID-­19 disease in hospitalised patients. Design A pragmatic, open-­label, multicentre, randomised controlled trial conducted from October 2020 to September 2021. Follow-­up was conducted at 30 and 60 days. The electronic medical record was used at all stages of the trial including screening, enrolment, randomisation, event ascertainment and follow-­up. Setting Four centres in the Yale New Haven Health System. Participants Non-­critically ill hospitalised patients with COVID-­19. Interventions Patients were randomised 1:1 to either colchicine plus high-­intensity rosuvastatin in addition to standard of care versus standard of care alone. Assigned treatment was continued for the duration of index hospitalisation or 30 days, whichever was shorter. Primary and secondary outcome measures The prespecified primary endpoint was progression to severe COVID-­19 disease (new high-­flow or non-­invasive ventilation, mechanical ventilation, need for vasopressors, renal replacement therapy or extracorporeal membrane oxygenation, or death) or arterial/venous thromboembolic events (ischaemic stroke, myocardial infarction, deep venous thrombosis or pulmonary embolism) evaluated at 30 days. Results Among the 250 patients randomised in this trial (125 to each arm), the median age was 61 years, 44% were women, 15% were Black and 26% were Hispanic/ Latino. As part of the standard of care, patients received remdesivir (87%), dexamethasone (92%), tocilizumab (18%), baricitinib (2%), prophylactic/therapeutic anticoagulation (98%) and aspirin (91%). The trial was terminated early by the data and safety monitoring board for futility. No patients were lost to follow-­up due to electronic medical record follow-­up. There was no significant difference in the primary endpoint at 30..