Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
Tardif et al.,
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.
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, 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
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit