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, COLCORONA, NCT04322682, Jan 2021 (preprint)
Colchicine for COVID-19
5th treatment shown to reduce risk in
September 2020, now with p = 0.00000015 from 57 studies.
No treatment is 100% effective. Protocols
combine treatments.
6,300+ studies for
210+ treatments. c19early.org
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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 Medicine1.
|
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.
|
|
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, 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).
Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
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 ClinicalTrials.gov (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
is less effective
