Covid-19 Living Data

Trial NCT04322682
Publication COLCORONA - Tardif JC, Lancet Respir Med (2021) (published paper)
Dates: 2020-03-23 to 2020-12-22
Funding: Public/non profit ( The Government of Quebec, the Bill & Melinda Gates Foundation, the National Heart, Lung, and Blood Institute of the US National Institutes of Health, the Montreal Heart Institute Foundation, the NYU Grossman School of Medicine, the Rudin Family Foundation, and philanthropist Sophie Desmarais.)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Brazil, Canada, Greece, South Africa, Spain, USA Follow-up duration (days): 30
Inclusion criteria	Patients ≥ 40 years of age received a diagnosis of COVID-19 within 24 hours of enrollment not currently hospitalized and not under immediate consideration for hospitalization presented at least one of the following high-risk criteria: age of 70 years or older, obesity (body-mass index of 30 kg/m2 or more), diabetes, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease, known heart failure, known coronary disease, fever of at least 38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil and low lymphocyte counts women not of childbearing potential or practicing adequate contraception
Exclusion criteria	Inflammatory bowel disease, chronic diarrhea or malabsorption pre-existent progressive neuromuscular disease estimated glomerular filtration rate less than 30 ml/minute/1.73 m2 severe liver disease current treatment with colchicine current chemotherapy for cancer history of significant sensitivity to colchicine
Interventions
	Treatment Colchicine 0.5 mg twice daily days 1-3, then once daily the following 27 days.
	Control Placebo
Participants
	Randomized NR Analyzed 4488 participants Colchicine=2235 Placebo=2253
	Characteristics of participants N= 4488 Mean age : NR 2067 males Severity : Mild: n= / Asymptomatic: n= Number of vaccinated participants: NR
Primary outcome
	In the register Number of participants who die or require hospitalization due to COVID-19 infection [ Time Frame: 30 days post randomization ]
	In the report Composite of death or hospitalization due to COVID-19 infection in the 30 days following randomization
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the prospective trial registry and study website were used in data extraction and assessment of risk of bias. There were no substantive differences between the pre-print article and the trial registry. The study was terminated early due to logistical issues related to maintaining the central study call center active 24 hours per day for a prolonged period of time, as well as the need to provide healthcare systems with study results in a timely fashion given the state of the COVID-19 pandemic. At termination, 75% of the planned patients were recruited and had completed the 30-day follow-up.