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.

Hossein Kasiri, Mobin Ghazaiean, Nima Rouhani, Fahimeh Naderi-Behdani, Monireh Ghazaeian, Robabeh Ghodssi-Ghassemabadi