The effects of colchicine on hospitalized COVID-19 patients: A randomized, double-blind, placebo-controlled clinical trial

This prospective, randomized, double-blind, placebo-controlled clinical trial evaluated colchicine as adjunct therapy in hospitalized adults with severe COVID-19. Patients were randomized 1:1 to colchicine (2 mg loading dose, then 0.5 mg twice daily for 7 days) or placebo; all received remdesivir and interferon beta-1b per national protocol. Primary outcome was clinical response (ordinal scale 1–2). Secondary outcomes included hospital complications and 28-day mortality. Of 110 enrolled, 106 were analyzed. Baseline characteristics were similar. By day 7, clinical response occurred in 58.8% (control) vs 63.6% (colchicine) (p=0.61; OR=1.23, 95% CI 0.560–2.68). By day 14, response was 82.4% vs 87.3% (p=0.48; OR=1.47, 95% CI 0.503–4.29). No significant differences were observed in ICU admission, intubation, length of stay, or 28-day mortality. Gastrointestinal adverse events (diarrhea, nausea) were more frequent with colchicine. Colchicine did not improve clinical outcomes and posed notable GI side effects.