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Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Horby, Peter W.; Campbell, Mark; Spata, Enti; Emberson, Jonathan R.; Staplin, Natalie; Pessoa-Amorim, Guilherme; Peto, Leon; Wiselka, Martin; Wiffen, Laura; Tiberi, Simon; Caplin, Ben; Wroe, Caroline; Green, Christopher; Hine, Paul; Prudon, Benjamin; George, Tina; Wight, Andrew; Baillie, J. Kenneth; Basnyat, Buddha; Buch, Maya; Chappell, Lucy C.; Day, Jeremy; Faust, Saul N.; Hamers, Raph L.; Jaki, Thomas; Juszczak, Edmund; Jeffery, Katie; Lim, Wei Shen; Montgomery, Alan; Mumford, Andrew; Rowan, Kathryn; Thwaites, Guy; Mafham, Marion; Haynes, Richard; Landray, Martin J.

Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial Thumbnail


Authors

Peter W. Horby

Mark Campbell

Enti Spata

Jonathan R. Emberson

Natalie Staplin

Guilherme Pessoa-Amorim

Leon Peto

Martin Wiselka

Laura Wiffen

Simon Tiberi

Ben Caplin

Caroline Wroe

Christopher Green

Paul Hine

Benjamin Prudon

Tina George

Andrew Wight

J. Kenneth Baillie

Buddha Basnyat

Maya Buch

Lucy C. Chappell

Jeremy Day

Saul N. Faust

Raph L. Hamers

Thomas Jaki

Katie Jeffery

Wei Shen Lim

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Andrew Mumford

Kathryn Rowan

Guy Thwaites

Marion Mafham

Richard Haynes

Martin J. Landray



Abstract

Background: Colchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19. Methods: In this streamlined, randomised, controlled, open-label trial, underway at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Patients were eligible for inclusion in the study if they were admitted to hospital with clinically suspected or laboratory confirmed SARS-CoV-2 infection and had 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. Eligible and consenting adults were randomly assigned (1:1) to receive either usual standard of care alone (usual care group) or usual standard of care plus colchicine (colchicine group) using web-based simple (unstratified) randomisation with allocation concealment. Participants received colchicine 1 mg after randomisation followed by 500 μg 12 h later and then 500 μg twice a day by mouth or nasogastric tube for 10 days in total or until discharge. Dose frequency was halved for patients receiving a moderate CYP3A4 inhibitor (eg, diltiazem), patients with an estimated glomerular filtration rate of less than 30 mL/min per 1·73m2, and those with an estimated bodyweight of less than 70 kg. The primary outcome was 28-day mortality, secondary endpoints included time to discharge, the proportion of patients discharged from hospital within 28 days, and, in patients not on invasive mechanical ventilation at randomisation, a composite endpoint of invasive mechanical ventilation or death. All analyses were by intention-to-treat. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between Nov 27, 2020, and March 4, 2021, 11 340 (58%) of 19 423 patients enrolled into the RECOVERY trial were eligible to receive colchicine; 5610 (49%) patients were randomly assigned to the colchicine group and 5730 (51%) to the usual care group. Overall, 1173 (21%) patients in the colchicine group and 1190 (21%) patients in the usual care group died within 28 days (rate ratio 1·01 [95% CI 0·93 to 1·10]; p=0·77). Consistent results were seen in all prespecified subgroups of patients. Median time to discharge alive (10 days [IQR 5 to >28]) was the same in both groups, and there was no significant difference in the proportion of patients discharged from hospital alive within 28 days (3901 [70%] patients in the colchicine group and 4032 [70%] usual care group; rate ratio 0·98 [95% CI 0·94 to 1·03]; p=0·44). In those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (1344 [25%] in the colchicine group vs 1343 [25%] patients in the usual care group; risk ratio 1·02 [95% CI 0·96 to 1·09]; p=0·47). Interpretation: In adults hospitalised with COVID-19, colchicine was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. Funding: UK Research and Innovation (Medical Research Council), National Institute of Health Research, and Wellcome Trust.

Citation

Horby, P. W., Campbell, M., Spata, E., Emberson, J. R., Staplin, N., Pessoa-Amorim, G., …Landray, M. J. (2021). Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respiratory Medicine, 9(12), 1419-1426. https://doi.org/10.1016/s2213-2600%2821%2900435-5

Journal Article Type Article
Acceptance Date Sep 18, 2021
Online Publication Date Oct 18, 2021
Publication Date Dec 1, 2021
Deposit Date Oct 22, 2021
Publicly Available Date Mar 28, 2024
Journal The Lancet Respiratory Medicine
Print ISSN 2213-2600
Electronic ISSN 2213-2619
Publisher Elsevier BV
Peer Reviewed Peer Reviewed
Volume 9
Issue 12
Pages 1419-1426
DOI https://doi.org/10.1016/s2213-2600%2821%2900435-5
Keywords Pulmonary and Respiratory Medicine
Public URL https://nottingham-repository.worktribe.com/output/6508164
Publisher URL https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00435-5/fulltext
Related Public URLs https://www.sciencedirect.com/science/article/pii/S2213260021004355
Additional Information Writing Committee (on behalf of the RECOVERY Collaborative Group)

Peter W Horby, Mark Campbell, Enti Spata, Jonathan R Emberson, Natalie Staplin, Guilherme Pessoa-Amorim, Leon Peto, Martin Wiselka, Laura Wiffen, Simon Tiberi, Ben Caplin, Caroline Wroe, Christopher Green, Paul Hine, Benjamin Prudon, Tina George, Andrew Wight, J Kenneth Baillie, Buddha Basnyat, Maya Buch, Lucy C Chappell, Jeremy Day, Saul N Faust, Raph L Hamers, Thomas Jaki, Edmund Juszczak, Katie Jeffery, Wei Shen Lim, Alan Montgomery, Andrew Mumford, Kathryn Rowan, Guy Thwaites, Marion Mafham, Richard Haynes, and Martin J Landray.

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