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Background  Colchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated.    Objective  To address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19.    Design  We conducted a triple-blind parallel non-stratified placebo-controlled clinical trial.    Participants  We recruited 116 hospitalized patients with severe COVID-19 in Mexico.    Interventions  Patients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment.    Main Measures  The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients.    Key Results  Fifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35–1.93,  P  = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66–3.88,  P  = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A.    Conclusions  Colchicine is safe but not effective in the treatment of severe COVID-19.    Trial Registration  ClinicalTrials.gov Identifier: NCT04367168.

Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID)