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0 0.5 1 1.5 2+ Mortality 44% Improvement Relative Risk Death/hospitalization 20% primary Ventilation 47% Hospitalization 20% Colchicine  COLCORONA  LATE TREATMENT  DB RCT Is late treatment with colchicine beneficial for COVID-19? Double-blind RCT 4,488 patients in multiple countries (Mar 2020 - Jan 2021) Lower mortality (p=0.3) and death/hosp. (p=0.079), not sig. Tardif et al., The Lancet Respiratory .., Jan 2021 Favors colchicine Favors control

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

Tardif et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00222-8 (date from preprint), COLCORONA, NCT04322682
Jan 2021  
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RCT for relatively low risk outpatients, 2235 treated with colchicine a mean of 5.3 days after the onset of symptoms, and 2253 controls, showing lower mortality, ventilation, and hospitalization with treatment.
This study was submitted to NEJM which delayed for ~6 months and then said they were not interested, then to JAMA which delayed for ~6 months and then said they were not interested, and then to the Lancet which delayed for ~6 months and then said they were not interested, and finally was published in Lancet Respiratory Medicine
risk of death, 43.9% lower, RR 0.56, p = 0.30, treatment 5 of 2,235 (0.2%), control 9 of 2,253 (0.4%), NNT 569, odds ratio converted to relative risk.
risk of death/hospitalization, 20.0% lower, RR 0.80, p = 0.08, treatment 104 of 2,235 (4.7%), control 131 of 2,253 (5.8%), NNT 86, odds ratio converted to relative risk, primary outcome.
risk of mechanical ventilation, 46.8% lower, RR 0.53, p = 0.09, treatment 11 of 2,235 (0.5%), control 21 of 2,253 (0.9%), NNT 227, odds ratio converted to relative risk.
risk of hospitalization, 20.0% lower, RR 0.80, p = 0.09, treatment 101 of 2,235 (4.5%), control 128 of 2,253 (5.7%), NNT 86, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tardif et al., 27 Jan 2021, Double Blind Randomized Controlled Trial, multiple countries, peer-reviewed, 44 authors, study period 23 March, 2020 - 21 January, 2021, average treatment delay 5.3 days, dosage 1mg days 1-3, 0.5mg days 4-30, trial NCT04322682 (history) (COLCORONA).
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Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
Jean-Claude Tardif, MD Nadia Bouabdallaoui, Philippe L L'allier, MD Daniel Gaudet, MD Binita Shah, Michael H Pillinger, MD Jose Lopez-Sendon, Protasio Da Luz, Lucie Verret, MSc Sylvia Audet, Prof Jocelyn Dupuis, André Denault, PhD Martin Pelletier, PhD Philippe A Tessier, Sarah Samson, Denis Fortin, Jean-Daniel Tardif, David Busseuil, Elisabeth Goulet, Chantal Lacoste, Anick Dubois, Avni Y Joshi, David D Waters, Priscilla Hsue, Norman E Lepor, Frédéric Lesage, Nicolas Sainturet, Eve Roy-Clavel, Zohar Bassevitch, Andreas Orfanos, Gabriela Stamatescu, Jean C Grégoire, Lambert Busque, Christian Lavallée, Pierre-Olivier Hétu, Jean-Sébastien Paquette, Spyridon G Deftereos, Sylvie Levesque, Mariève Cossette, Anna Nozza, Malorie Chabot-Blanchet, Marie-Pierre Dubé, Marie-Claude Guertin, Guy Boivin
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(21)00222-8
Background Evidence suggests a role for excessive inflammation in COVID-19 complications. Colchicine is an oral anti-inflammatory medication beneficial in gout, pericarditis, and coronary disease. We aimed to investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission. Methods The present study is a phase 3, randomised, double-blind, adaptive, placebo-controlled, multicentre trial. The study was done in Brazil, Canada, Greece, South Africa, Spain, and the USA, and was led by the Montreal Heart Institute. Patients with COVID-19 diagnosed by PCR testing or clinical criteria who were not being treated in hospital were eligible if they were at least 40 years old and had at least one high-risk characteristic. The randomisation list was computer-generated by an unmasked biostatistician, and masked randomisation was centralised and done electronically through an automated interactive web-response system. The allocation sequence was unstratified and used a 1:1 ratio with a blocking schema and block sizes of six. Patients were randomly assigned to receive orally administered colchicine (0•5 mg twice per day for 3 days and then once per day for 27 days thereafter) or matching placebo. The primary efficacy endpoint was the composite of death or hospital admission for COVID-19. Vital status at the end of the study was available for 97•9% of patients. The analyses were done according to the intention-to-treat principle. The COLCORONA trial is registered with (NCT04322682) and is now closed to new participants. Findings Trial enrolment began in March 23, 2020, and was completed in Dec 22, 2020. A total of 4488 patients (53•9% women; median age 54•0 years, IQR 47•0-61•0) were enrolled and 2235 patients were randomly assigned to colchicine and 2253 to placebo. The primary endpoint occurred in 104 (4•7%) of 2235 patients in the colchicine group and 131 (5•8%) of 2253 patients in the placebo group (odds ratio [OR] 0•79, 95•1% CI 0•61-1•03; p=0•081). Among the 4159 patients with PCR-confirmed COVID-19, the primary endpoint occurred in 96 (4•6%) of 2075 patients in the colchicine group and 126 (6•0%) of 2084 patients in the placebo group (OR 0•75, 0•57-0•99; p=0•042). Serious adverse events were reported in 108 (4•9%) of 2195 patients in the colchicine group and 139 (6•3%) of 2217 patients in the placebo group (p=0•051); pneumonia occurred in 63 (2•9%) of 2195 patients in the colchicine group and 92 (4•1%) of 2217 patients in the placebo group (p=0•021). Diarrhoea was reported in 300 (13•7%) of 2195 patients in the colchicine group and 161 (7•3%) of 2217 patients in the placebo group (p<0•0001). Interpretation In community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital..
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Late treatment
is less effective
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