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, Jiram Torres-Ruiz, 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, Jiram Torres-Ruiz

Abstract

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.

Conflict of interest statement

The authors declare that they do not have a conflict of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flow diagram depicting the recruitment and follow-up process throughout the protocol
Fig. 2
Fig. 2
Kaplan–Meier curves showing the time for the development of the primary outcome (A) and the total amount of days of hospital stay (B)
Fig. 3
Fig. 3
Analysis of the laboratory and immunological features of patients with severe COVID-19 after treatment. Patients who received colchicine had a higher BUN (A), and lower levels of IL-8, IL-12p70, and IL-17A (B–D)

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