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0 0.5 1 1.5 2+ Mortality 70% Improvement Relative Risk Death/hospitalization -30% Death/hospitalization (b) 22% Recovery -6% Colchicine  Dorward et al.  LATE TREATMENT  RCT Is late treatment with colchicine beneficial for COVID-19? RCT 1,301 patients in the United Kingdom (March - May 2021) Lower mortality with colchicine (not stat. sig., p=0.43) Dorward et al., British J. General Pra.., Sep 2021 Favors colchicine Favors control

Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial

Dorward et al., British Journal of General Practice, doi:10.3399/BJGP.2022.0083 (date from preprint)
Sep 2021  
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Colchicine for COVID-19
6th treatment shown to reduce risk in September 2020
*, now known with p = 0.00000024 from 52 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments.
Late treatment RCT with 156 colchicine patients in the UK, showing no significant differences. ISRCTN86534580.
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).
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.
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.
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.
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.
This PaperColchicineAll
Colchicine for COVID-19 in the community (PRINCIPLE): a randomised, controlled, adaptive platform trial
Jienchi Dorward, Ly-Mee Yu, Gail Hayward, Benjamin R Saville, Oghenekome Gbinigie, Oliver Van Hecke, Emma Ogburn, Philip H Evans, Nicholas Pb Thomas, Mahendra G Patel, Duncan Richards, Nicholas Berry, Michelle A Detry, Christina Saunders, Mark Fitzgerald, Victoria Harris, Milensu Shanyinde, Simon De Lusignan, Monique I Andersson, Christopher C Butler, Fd Richard Hobbs
British Journal of General Practice, doi:10.3399/bjgp.2022.0083
Background: Colchicine has been proposed as a COVID-19 treatment. Aim: To determine whether colchicine reduces time to recovery and COVID-19 related hospitalisations/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, or ≥18 years with comorbidities or shortness of breath, and unwell ≤14 days with suspected COVID-19 in the community were randomised to usual care, usual care plus colchicine (500µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery, and hospitalisation/death related to COVID-19, within 28 days, analysed using Bayesian models. The hypothesis for the time to recovery endpoint is evaluated first, and if superiority is declared on time to recovery, the hypothesis for the second co-primary endpoint of hospitalisation/death is then evaluated. To determine futility, we pre-specified a clinically meaningful benefit in time to first reported recovery as a hazard ratio of 1.2 or larger (equating to approximately 1.5 days benefit in the colchicine arm, assuming 9 days recovery in the usual care arm).
Strengths include the pragmatic design of the PRINCIPLE trial which allowed for efficient evaluation of the effectiveness of colchicine as an early, standalone intervention as it might be used in the community. We focused on patients at increased risk of complications and used routine electronic health records to confirm hospitalisation/death, and obtained primary outcome data on over 95% of participants. Although our primary analysis was restricted to SARS-CoV-2 positive patients, we conducted secondary analyses of the co-primary outcomes among patients with suspected COVID-19 but without PCR confirmed SARS-CoV-2 infection, as limited SARS-CoV-2 testing may necessitate early empirical treatment in low resource settings. Furthermore, variation in PCR testing sensitivity, particularly if self-administered, means some participants will have had false negative tests.( 28 ) Time to recovery estimates were similar in the SARS-CoV-2 positive population, all participants irrespective of SARS-CoV-2 status, as well as the concurrent randomisation SARS-CoV-2 positive population (the latter populations are most analogous to those in traditional two arm trials). Although the sample size of the colchicine group in PRINCIPLE was relatively small, the Bayesian primary analysis model leverages previous enrolments in the usual care arm to increase the precision of estimates, which allow us to declare futility with high precision due to very low probability of a meaningful benefit of..
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Butler, Yu, Dorward, Gbinigie, Hayward et al., Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial, The Lancet Respiratory Medicine
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Yu, Bafadhel, Dorward, Hayward, Saville et al., Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Late treatment
is less effective
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