The Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) was an international randomized double-blind controlled trial which investigated whether short-term treatment with colchicine decreased the rate of death, rate of hospitalization, and need for medical intervention among adult patients recently diagnosed with COVID-19. A secondary objective was to determine the safety of the intervention among a high-risk population. Patients were eligible for enrollment if they were at least 40 years old, had a PCR-confirmed diagnosis of COVID-19 within the 24 hours of enrollment, were not hospitalized or considered for hospitalization, and met at least one high-risk criterion: at least 70 years old, obese, diagnosed with diabetes mellitus, uncontrolled hypertension, history of respiratory disease, history of heart failure, history of coronary disease, fever of at least 38.4°C (101°F) within the last 48 hours, shortness of breath, bicytopenia, pancytopenia, or a combination of elevated neutrophil count and low lymphocyte count. Patients were excluded if they had inflammatory bowel disease, chronic diarrhea, malabsorption, estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m², severe liver disease, current treatment with colchicine, current chemotherapy for cancer, or a history of sensitivity to colchicine.

A total of 4,488 participants were enrolled and randomly assigned to the treatment or control group. Participants were randomized in a 1:1 ratio to receive either 0.5 mg of colchicine or a placebo, which were taken orally twice daily for the first 3 days and then once daily for the last 27 days. Follow-up visits were conducted 15 and 30 days after randomization. Data was collected on patient demographics, medical history, substance use, medications, procedures, healthcare encounters, hospitalization, and laboratory results.