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Efficacy of Colchicine in Non-Hospitalized Patients with COVID-19

2021; Cold Spring Harbor Laboratory; Linguagem: Inglês

10.1101/2021.01.26.21250494

Autores

Jean‐Claude Tardif, Nadia Bouabdallaoui, Philippe L. L’Allier, Daniel Gaudet, Binita Shah, Michael H. Pillinger, José López‐Sendón, Protásio Lemos da Luz, Lucie Verret, Sylvia Audet, Jocelyn Dupuis, André Denault, Martin Pelletier, Philippe A. Tessier, Sarah Samson, Denis Fortin, Jean-Daniel Tardif, David Busseuil, Elisabeth Goulet, Chantal Lacoste, Anick Dubois, Avni Y. Joshi, David D. Waters, Priscilla Y. Hsue, Norman E. Lepor, Frédéric Lesage, Nicolas Sainturet, Eve Roy-Clavel, Zohar Bassevitch, Andreas Orfanos, Jean‐Claude Grégoire, Lambert Busque, Christian Lavallée, Pierre‐Olivier Hétu, Jean‐Sébastien Paquette, Sylvie Lévesque, Mariève Cossette, Anna Nozza, Malorie Chabot-Blanchet, Marie‐Pierre Dubé, Marie‐Claude Guertin, Guy Boivin,

Tópico(s)

SARS-CoV-2 and COVID-19 Research

Resumo

ABSTRACT Background Evidence suggests the role of an inflammatory storm in COVID-19 complications. Colchicine is an orally administered, anti-inflammatory medication beneficial in gout, pericarditis and coronary disease. Methods We performed a randomized, double-blind trial involving non-hospitalized patients with COVID-19 diagnosed by polymerase chain reaction (PCR) testing or clinical criteria. The patients were randomly assigned to receive colchicine (0.5 mg twice daily for 3 days and once daily thereafter) or placebo for 30 days. The primary efficacy endpoint was the composite of death or hospitalization for COVID-19. Results A total of 4488 patients were enrolled. The primary endpoint occurred in 4.7% of the patients in the colchicine group and 5.8% of those in the placebo group (odds ratio, 0.79; 95.1% confidence interval (CI), 0.61 to 1.03; P=0.08). Among the 4159 patients with PCR-confirmed COVID-19, the primary endpoint occurred in 4.6% and 6.0% of patients in the colchicine and placebo groups, respectively (odds ratio, 0.75; 95% CI, 0.57 to 0.99; P=0.04). In these patients with PCR-confirmed COVID-19, the odds ratios were 0.75 (95% CI, 0.57 to 0.99) for hospitalization due to COVID-19, 0.50 (95% CI, 0.23 to 1.07) for mechanical ventilation, and 0.56 (95% CI, 0.19 to 1.66) for death. Serious adverse events were reported in 4.9% and 6.3% in the colchicine and placebo groups (P=0.05); pneumonia occurred in 2.9% and 4.1% of patients (P=0.02). Diarrhea was reported in 13.7% and 7.3% in the colchicine and placebo groups (P<0.0001). Conclusion Among non-hospitalized patients with COVID-19, colchicine reduces the composite rate of death or hospitalization. (COLCORONA ClinicalTrials.gov number: NCT04322682 )

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