Effect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19 : a randomized clinical trial.
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
JAMA Network Open
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2574-3805
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JAMA Network Open. 2021;4(12).
Abstract
Description
Importance: 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.
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.
Citation
Diaz, 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.2021.41328