2026-04-272026-04-27Diaz, R., Orlandini, A., Castellana, N., Caccavo, A., Corral, P., Corral, G., Chacón, C., Lamelas, P., Botto, F., Díaz, M. L., Domínguez, J. M., Pascual, A., Rovito, C., Galatte, A., Scarafia, F., Sued, O., Gutierrez, O., Jolly, S. S., Miró, J. M., Eikelboom, J., Loeb, M., Maggioni, A. P., Bhatt, D. L., & Yusuf, S. (2021). Effect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19: A randomized clinical trial. JAMA Network Open, 4(12), e2141328. https://doi.org/10.1001/jamanetworkopen.2021.413282574-3805https://dspace.ufasta.edu.ar/handle/123456789/88037Importance: Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. Objective: To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. Design, Setting, and Participants: The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription–polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Interventions: Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. Main Outcomes and Measures: The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. Results: A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). Conclusions and Relevance: This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia.Fil: Diaz, Rafael. Estudios Clínicos Latino América; Argentina.Fil: Diaz, Rafael. Instituto Cardiovascular de Rosario; Argentina.Fil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina.Fil: Orlandini, Andrés. Instituto Cardiovascular de Rosario; Argentina.Fil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina.Fil: Castellana, Noelia. Universidad Nacional de Rosario; Argentina.Fil: Caccavo, Alberto. Hospital de Coronel Suárez Raúl Alfredo Caccavo, Universidad Provincial del Sudoeste; Argentina.Fil: Corral, Pablo. Departamento de Investigación, Facultad de Medicina, Universidad FASTA; Argentina.Fil: Corral, Gonzalo. Infectología Clínica de Mayo; Argentina.Fil: Chacón, Carolina. Estudios Clínicos Latino América; Argentina.Fil: Chacón, Carolina. Universidad Abierta Interamericana; Argentina.Fil: Chacón, Carolina. Unidad Coronaria de Sanatorio Delta de Rosario; Argentina.Fil: Chacón Carolina. Comité de Epidemiologia y Prevención Cardiovascular de la Federación Argentina de Cardiología; Argentina.Fil: Lamelas, Pablo. Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.Fil: Lamelas, Pablo. Instituto Cardiovascular de Buenos Aires; Argentina.Fil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; Argentina.Fil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina.Fil: Díaz, María Luz. Instituto Cardiovascular de Rosario; Argentina.Fil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina.Fil: Domínguez, Juan Manuel. Instituto Cardiovascular de Rosario; Argentina.Fil: Domínguez, Juan Manuel. Heart Failure and Heart Transplant Unit, Instituto Cardiovascular de Rosario; Argentina.Fil: Pascual, Andrea. Estudios Clínicos Latino América; Argentina.Fil: Rovito, Carla. Estudios Clínicos Latino América; Argentina.Fil: Galatte, Agustina. Estudios Clínicos Latino América; Argentina.Fil: Scarafia, Franco. Estudios Clínicos Latino América; Argentina.Fil: Scarafia, Franco. Statistics Department, Universidad Nacional de Rosario; Argentina.Fil: Sued, Omar. Fundación Huésped; Argentina.Fil: Gutierrez, Omar. Ministerio de Salud de Jujuy; Argentina.Fil: Jolly, Sanjit S.. Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.Fil: Miró, José M.. Infectious Diseases Service, Hospital Clínic, Instituto de Investigaciones Biomédicas August Pi i Sunyer, University of Barcelona; España.Fil: Eikelboom, John. Medicine, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.Fil: Loeb, Mark. Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.Fil: Loeb, Mark. Departments of Pathology and Molecular Medicine, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.Fil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Italia.Fil: Bhatt, Deepak L.. Brigham and Women’s Hospital and Harvard Medical School; Estados Unidos.Fil: Yusuf, Salim. Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.application/pdfinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licences/by-nc-nd/3.0/deed.es_AREnfermedades infecciosasCoronavirus (COVID-19)ReumatologíaMedicina de cuidados intensivosInsuficiencia respiratoria y ventilaciónNeumoníainfo:eu-repo/semanticspte/article