Colchicine
Colchicine 0.5 mg per os twice daily for the first 3 days, then once daily for the last 27 days.
Placebo
Placebo per os twice daily for the first 3 days, then once daily for the last 27 days.
COVID 19 outpatients
adults >= 40 years old diagnosed with COVID19 within the last 24h; not currently hospitalized and not under immediate consideration for hospitalization. Patients must possess at least one high-risk criteria (>70 years old, diabetes mellitus, uncontrolled hypertension, respiratory disease, heart failure, coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count).
Double blind, randomized.
Brazil, Canada, Greece, South Africa, Spain, and the USA
multiple testing
premature discontinuation due to logistical issues
PRINCIPLE (COLCHICINE), 2021 ISRCTN86534580
colchicine (n=212) vs. standard of care (n=2081)
randomized controlled trial
some concerns about risk of bias
Colchicine
Usual care plus colchicine 500µg daily for 14 days.
Usual care
COVID 19 outpatients
Open-label.
Participants were followed up through an online, daily symptom diary for 28 days after randomisation, supplemented with telephone calls to non-responders on days 7, 14 and 28. The diary includes questions about illness recovery (ascertained by answering the question, “Do you feel recovered today? (i.e. symptoms associated with illness are no longer a problem) Yes/No”), overall illness severity (a rating of how well they are feeling on a scale of 1-10 [1 being the worst and 10 being the best]), individual symptom severity on a four-point scale (0 = no problem to 3 =major problem), and healthcare service utilisation.