@article {Dorwarde446, author = {Jienchi Dorward and Ly-Mee Yu and Gail Hayward and Benjamin R Saville and Oghenekome Gbinigie and Oliver Van Hecke and Emma Ogburn and Philip H Evans and Nicholas PB Thomas and Mahendra G Patel and Duncan Richards and Nicholas Berry and Michelle A Detry and Christina Saunders and Mark Fitzgerald and Victoria Harris and Milensu Shanyinde and Simon de Lusignan and Monique I Andersson and Christopher C Butler and FD Richard Hobbs}, editor = {,}, title = {Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial}, volume = {72}, number = {720}, pages = {e446--e455}, year = {2022}, doi = {10.3399/BJGP.2022.0083}, publisher = {Royal College of General Practitioners}, abstract = {Background Colchicine has been proposed as a COVID-19 treatment.Aim To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community.Design and setting Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE).Method Adults aged >=65 years or >=18 years with comorbidities or shortness of breath, and unwell for <=14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 {\textmu}g daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models.Results The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95\% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8\%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95\% CrI = 0.28 to 1.89) and an estimated difference of -0.4\% (95\% CrI = -2.7 to 2.4).Conclusion Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.}, issn = {0960-1643}, URL = {https://bjgp.org/content/72/720/e446}, eprint = {https://bjgp.org/content/72/720/e446.full.pdf}, journal = {British Journal of General Practice} }