Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial
et al., British Journal of General Practice, doi:10.3399/BJGP.2022.0083 (date from earlier preprint)
, Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial, British Journal of General Practice, doi:10.3399/BJGP.2022.0083 (date from earlier preprint)
Late treatment RCT with 156 colchicine patients in the UK, showing no significant differences. ISRCTN86534580.
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risk of death, 69.7% lower, RR 0.30, p = 0.43, treatment 0 of 156 (0.0%), control 1 of 120 (0.8%), NNT 120, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of death/hospitalization, 29.8% higher, RR 1.30, p = 0.66, treatment 6 of 156 (3.8%), control 4 of 133 (3.0%), odds ratio converted to relative risk, concurrent randomisation.
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risk of death/hospitalization, 22.1% lower, RR 0.78, p = 0.59, treatment 6 of 156 (3.8%), control 119 of 1,145 (10.4%), odds ratio converted to relative risk, including control patients before the colchicine arm started.
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risk of no recovery, 6.4% higher, HR 1.06, p = 0.67, treatment 156, control 133, inverted to make HR<1 favor treatment, time to alleviation of symptoms, concurrent randomisation.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Dorward et al., 23 Sep 2021, Randomized Controlled Trial, United Kingdom, peer-reviewed, 21 authors, study period 4 March, 2021 - 26 May, 2021, average treatment delay 6.0 days, dosage 0.5mg days 1-14.
Abstract: Accepted Manuscript
British Journal of General Practice
Colchicine for COVID-19 in the community (PRINCIPLE): a
randomised, controlled, adaptive platform trial
Dorward, Jienchi; Yu, Ly-mee; Hayward, Gail; Saville, Benjamin; Gbinigie,
Oghenekome; van Hecke, Oliver; Ogburn, Emma; Evans, Philip; Thomas,
Nicholas; Patel, Mahendra; Richards, Duncan; Berry, Nicholas ; Detry, Michelle; Saunders, Christina; Fitzgerald, Mark; Harris, Victoria; Shanyinde,
Milensu; de Lusignan, Simon; Andersson, Monique; Butler, Christopher;
Hobbs, FD Richard
DOI: https://doi.org/10.3399/BJGP.2022.0083
To access the most recent version of this article, please click the DOI URL in the line above.
Received 11 February 2022
Revised 25 February 2022
Accepted 02 March 2022
© 2022 The Author(s). This is an Open Access article distributed under the terms of the Creative
Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/). Published by
British Journal of General Practice. For editorial process and policies, see:
https://bjgp.org/authors/bjgp-editorial-process-and-policies
When citing this article please include the DOI provided above.
Author Accepted Manuscript
This is an ‘author accepted manuscript’: a manuscript that has been accepted for publication in British Journal of
General Practice, but which has not yet undergone subediting, typesetting, or correction. Errors discovered and
corrected during this process may materially alter the content of this manuscript, and the latest published version (the
Version of Record) should be used in preference to any preceding versions
Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled,
adaptive platform trial
PRINCIPLE Trial Collaborative Group¶
¶Writing committee listed below on behalf of the PRINCIPLE Trial Collaborative Group.
PRINCIPLE trial collaborators are listed in the appendix
Writing committee
Dr Jienchi Dorward (0000-0001-6072-1430)*1,2 clinical research fellow, Prof Ly-Mee Yu (00000003-0331-7364)*1 associate professor, Prof Gail Hayward (0000-0003-0852-627X)1 associate
professor, Dr Benjamin R Saville3,4 statistician, Dr Oghenekome Gbinigie (0000-0002-29634491)1 clinical research fellow, Dr Oliver Van Hecke (0000-0002-6229-5057)1 academic clinical
lecturer, Dr Emma Ogburn (0000-0001-7643-572X)1 director of operations, Prof Philip H Evans
(0000-0002-5277-3545)5,6 associate professor, Dr Nicholas PB Thomas (0000-0003-04606870)6,7 general practitioner, Prof Mahendra G Patel (0000-0001-6703-3542)1 professor, Prof
Duncan Richards (0000-0002-8093-7084)8 professor, Dr Nicholas Berry (0000-0001-87013258)3 statistician, Dr Michelle A Detry (0000-0002-2794-1439)3 statistician, Dr Christina
Saunders (0000-0003-4325-9568)3 statistician, Dr Mark Fitzgerald (0000-0002-8912-1663)3
statistician, Dr Victoria Harris (0000-0002-3345-2826)1 statistician, Dr Milensu Shanyinde
(0000-0003-4842-9247)1 statistician, Prof Simon de Lusignan (0000-0002-8553-2641)1,7
professor, Dr Monique I Andersson (0000-0003-0619-1074)9 consultant, Prof Christopher C
Butler professor (0000-0002-0102-3453), 1†Prof FD Richard Hobbs (0000-0001-7976-7172) 1†
professor
1
Writing Committee affiliations
1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
2. Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of
KwaZulu–Natal, Durban, South Africa
3. Berry Consultants, Texas, USA
4. Department of Biostatistics, Vanderbilt University School of..
Late treatment
is less effective
is less effective
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