• J Gen Intern Med · Jan 2022

    Randomized Controlled Trial

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

    • Abdiel Absalón-Aguilar, Marina Rull-Gabayet, Alfredo Pérez-Fragoso, Nancy R Mejía-Domínguez, Carlos Núñez-Álvarez, David Kershenobich-Stalnikowitz, José Sifuentes-Osornio, Alfredo Ponce-de-León, Fernanda González-Lara, Eduardo Martín-Nares, Sharon Montesinos-Ramírez, Martha Ramírez-Alemón, Pamela Ramírez-Rangel, Manlio F Márquez, Juan Carlos Plata-Corona, Guillermo Juárez-Vega, Diana Gómez-Martín, and Jiram Torres-Ruiz.
    • Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Domínguez Sección XVI, Tlalpan, Mexico City, Mexico.
    • J Gen Intern Med. 2022 Jan 1; 37 (1): 4144-14.

    BackgroundColchicine 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.ObjectiveTo address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19.DesignWe conducted a triple-blind parallel non-stratified placebo-controlled clinical trial.ParticipantsWe recruited 116 hospitalized patients with severe COVID-19 in Mexico.InterventionsPatients 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 MeasuresThe 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 ResultsFifty-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.ConclusionsColchicine is safe but not effective in the treatment of severe COVID-19.Trial RegistrationClinicalTrials.gov Identifier: NCT04367168.© 2021. The Author(s).

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