Effect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19 : a randomized clinical trial.

Simple item page
dc.creatorDiaz, Rafael
dc.creatorOrlandini, Andrés
dc.creatorCastellana, Noelia
dc.creatorCaccavo, Alberto
dc.creatorCorral, Pablo
dc.creatorCorral, Gonzalo
dc.creatorChacón, Carolina
dc.creatorLamelas, Pablo
dc.creatorBotto, Fernando
dc.creatorDíaz, María Luz
dc.creatorDomínguez, Juan Manuel
dc.creatorPascual, Andrea
dc.creatorRovito, Carla
dc.creatorGalatte, Agustina
dc.creatorScarafia, Franco
dc.creatorSued, Omar
dc.creatorGutierrez, Omar
dc.creatorJolly, Sanjit S.
dc.creatorMiró, José M.
dc.creatorEikelboom, John
dc.creatorLoeb, Mark
dc.creatorMaggioni, Aldo Pietro
dc.creatorBhatt, Deepak L.
dc.creatorYusuf, Salim
dc.date2021
dc.date.accessioned2026-04-27T22:23:03Z
dc.date.available2026-04-27T22:23:03Z
dc.descriptionImportance: 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.
dc.descriptionFil: Diaz, Rafael. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Diaz, Rafael. Instituto Cardiovascular de Rosario; Argentina.
dc.descriptionFil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Orlandini, Andrés. Instituto Cardiovascular de Rosario; Argentina.
dc.descriptionFil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Castellana, Noelia. Universidad Nacional de Rosario; Argentina.
dc.descriptionFil: Caccavo, Alberto. Hospital de Coronel Suárez Raúl Alfredo Caccavo, Universidad Provincial del Sudoeste; Argentina.
dc.descriptionFil: Corral, Pablo. Departamento de Investigación, Facultad de Medicina, Universidad FASTA; Argentina.
dc.descriptionFil: Corral, Gonzalo. Infectología Clínica de Mayo; Argentina.
dc.descriptionFil: Chacón, Carolina. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Chacón, Carolina. Universidad Abierta Interamericana; Argentina.
dc.descriptionFil: Chacón, Carolina. Unidad Coronaria de Sanatorio Delta de Rosario; Argentina.
dc.descriptionFil: Chacón Carolina. Comité de Epidemiologia y Prevención Cardiovascular de la Federación Argentina de Cardiología; Argentina.
dc.descriptionFil: Lamelas, Pablo. Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.descriptionFil: Lamelas, Pablo. Instituto Cardiovascular de Buenos Aires; Argentina.
dc.descriptionFil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; Argentina.
dc.descriptionFil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Díaz, María Luz. Instituto Cardiovascular de Rosario; Argentina.
dc.descriptionFil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Domínguez, Juan Manuel. Instituto Cardiovascular de Rosario; Argentina.
dc.descriptionFil: Domínguez, Juan Manuel. Heart Failure and Heart Transplant Unit, Instituto Cardiovascular de Rosario; Argentina.
dc.descriptionFil: Pascual, Andrea. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Rovito, Carla. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Galatte, Agustina. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Scarafia, Franco. Estudios Clínicos Latino América; Argentina.
dc.descriptionFil: Scarafia, Franco. Statistics Department, Universidad Nacional de Rosario; Argentina.
dc.descriptionFil: Sued, Omar. Fundación Huésped; Argentina.
dc.descriptionFil: Gutierrez, Omar. Ministerio de Salud de Jujuy; Argentina.
dc.descriptionFil: Jolly, Sanjit S.. Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.descriptionFil: Miró, José M.. Infectious Diseases Service, Hospital Clínic, Instituto de Investigaciones Biomédicas August Pi i Sunyer, University of Barcelona; España.
dc.descriptionFil: Eikelboom, John. Medicine, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.descriptionFil: Loeb, Mark. Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.descriptionFil: Loeb, Mark. Departments of Pathology and Molecular Medicine, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.descriptionFil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Italia.
dc.descriptionFil: Bhatt, Deepak L.. Brigham and Women’s Hospital and Harvard Medical School; Estados Unidos.
dc.descriptionFil: Yusuf, Salim. Division of Cardiology, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Canadá.
dc.formatapplication/pdf
dc.identifier.citationDiaz, 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
dc.identifier.issn2574-3805
dc.identifier.urihttps://dspace.ufasta.edu.ar/handle/123456789/88037
dc.languageeng
dc.publisherJAMA Network Open
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rightshttp://creativecommons.org/licences/by-nc-nd/3.0/deed.es_AR
dc.sourceJAMA Network Open. 2021;4(12).
dc.subjectEnfermedades infecciosas
dc.subjectCoronavirus (COVID-19)
dc.subjectReumatología
dc.subjectMedicina de cuidados intensivos
dc.subjectInsuficiencia respiratoria y ventilación
dc.subjectNeumonía
dc.titleEffect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19 : a randomized clinical trial.
dc.typeinfo:eu-repo/semanticspte/article
dc.typeinfo:ar-repo/semantics/artículo
dc.typeinfo:eu-repo/semantics/accedVersion

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Corral_2021_ 2574-3805.pdf
Size:
997.57 KB
Format:
Adobe Portable Document Format
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed to upon submission
Description:
Download

Collections

Libros, artículos de libros, artículos científicos en Ciencias Médicas