Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00222-8 (date from earlier preprint), COLCORONA, NCT04322682 (history)
, Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded,.., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00222-8 (date from earlier preprint), COLCORONA, NCT04322682
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.Although the 44% lower mortality is not statistically significant, it is consistent with the significant 35% lower mortality [22‑45%] from meta analysis of the 36 mortality results to date.
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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.
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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.
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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.
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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.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Tardif et al., 27 Jan 2021, Double Blind Randomized Controlled Trial, Canada, peer-reviewed, 44 authors, average treatment delay 5.3 days, dosage 1mg days 1-3, 0.5mg days 4-30, trial NCT04322682 (history) (COLCORONA).
Abstract: Articles
Colchicine for community-treated patients with COVID-19
(COLCORONA): a phase 3, randomised, double-blinded,
adaptive, placebo-controlled, multicentre trial
Jean-Claude Tardif, Nadia Bouabdallaoui, Philippe L L’Allier, Daniel Gaudet, Binita Shah, Michael H Pillinger, Jose Lopez-Sendon, Protasio da Luz,
Lucie Verret, Sylvia Audet, Jocelyn Dupuis, André Denault, Martin Pelletier, 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, for the COLCORONA Investigators*
Summary
Lancet Respir Med 2021;
9: 924–32
Published Online
May 27, 2021
https://doi.org/10.1016/
S2213-2600(21)00222-8
See Comment page 811
*Members listed in the appendix
Montreal Heart Institute
(Prof J-C Tardif MD,
N Bouabdallaoui MD,
P L L’Allier MD, L Verret MSc,
S Audet MSc, Prof J Dupuis MD,
Prof A Denault MD,
S Samson BSN, D Fortin BSN,
J-D Tardif BSc, D Busseuil PhD,
E Goulet RN, C Lacoste DEC,
A Dubois PhD, Prof F Lesage PhD,
J C Grégoire MD,
Prof M-P Dubé PhD),
Ecogene-21 (D Gaudet MD), and
Department of Medicine
(D Gaudet), Université de
Montréal, Montreal, QC,
Canada; New York University
Grossman School of Medicine,
New York, NY, USA (B Shah MD,
Prof M H Pillinger MD); H La Paz,
IdiPaz, UAM, Ciber-CV, Madrid,
Spain (Prof J Lopez-Sendon MD);
Instituto do Coração, Hospital
das Clínicas, Faculdade de
Medicina, Universidade de São
Paulo, São Paulo, Brasil
(Prof P da Luz MD); Centre
Hospitalier Universitaire de
Québec, Université Laval,
Quebec City, QC, Canada
(M Pelletier PhD, P A Tessier PhD,
G Boivin MD); Mayo Clinic,
Rochester, MN, USA
(Prof A Y Joshi MD);
San Francisco General Hospital,
San Francisco, CA, USA
(Prof D D Waters MD,
Prof P Hsue MD); Cedars-Sinai
Heart Institute, Geffen School
of Medicine-UCLA, Los Angeles,
CA, USA (Prof N E Lepor MD);
Montréal Health Innovations
Coordinating Center, Montreal,
QC, Canada (N Sainturet PhD,
924
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..
Late treatment
is less effective
is less effective
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