Trial NCT04322682
Publication Tardif JC, Lancet Respir Med, 2021 (published paper)
Dates: 2020-03-23 to 2020-12-22
Funding: Mixed (Government of Quebec; the Bill & Melinda Gates Foundation; the National Heart, Lung, and Blood
Institute of the US National Institutes of Health; Montreal Heart Institute Foundation; NYU Grossman School
of Medicine; Rudin Family Foundation; 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 * participants (n1=* / n2= *) | |
| Characteristics of participants N=* Mean age : NR 2067 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| 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 stated 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. |