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dc.contributor.author
Diaz, Rafael
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Orlandini, Andrés
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Castellana, Noelia
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Caccavo, Alberto
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Corral, Pablo
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Corral, Gonzalo
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Chacón, Carolina
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Lamelas, Pablo
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Botto, Fernando
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Díaz, María Luz
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Domínguez, Juan Manuel
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Pascual, Andrea
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Rovito, Carla
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Galatte, Agustina
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Scarafia, Franco
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Sued, Omar
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Gutierrez, Omar
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Jolly, Sanjit S.
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Miró, José M.
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Eikelboom, John
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Loeb, Mark
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Maggioni, Aldo Pietro
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Bhatt, Deepak L.
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Yusuf, Salim
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Lopez, Lorena
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Leon de la Fuente, Ricardo Alfonso
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Forciniti, Cristian C. G.
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Colombo, Hugo
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Sabas, Nicolas
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Pilón, Leonardo
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Steren, Adriana P.
dc.date.available
2024-07-24T15:00:31Z
dc.date.issued
2022-05
dc.identifier.citation
Diaz, Rafael; Orlandini, Andrés; Castellana, Noelia; Caccavo, Alberto; Corral, Pablo; et al.; Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial; American Medical Association; JAMA Network Open; 4; 12; 5-2022; 1-12
dc.identifier.uri
http://hdl.handle.net/11336/240767
dc.description.abstract
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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
American Medical Association
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
Colchicina
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COVID-19
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Mortalidad
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Complicaciones
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Medicina Critica y de Emergencia
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Medicina Clínica
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
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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info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2024-07-05T11:48:22Z
dc.identifier.eissn
2574-3805
dc.journal.volume
4
dc.journal.number
12
dc.journal.pagination
1-12
dc.journal.pais
Estados Unidos
dc.description.fil
Fil: Diaz, Rafael. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
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Fil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
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Fil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; Argentina
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Fil: Caccavo, Alberto. Provincia de Buenos Aires. Dirección General de Cultura y Educación. Universidad Provincial del Sudoeste; Argentina
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Fil: Corral, Pablo. Universidad FASTA "Santo Tomas de Aquino"; Argentina
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Fil: Corral, Gonzalo. Infectología Clínica de Mayo; Argentina
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Fil: Chacón, Carolina. Estudios Clínicos Latino América; Argentina. Universidad Abierta Interamericana; Argentina. Unidad Coronaria de Sanatorio Delta de Rosario; Argentina. Comite de Epidemiologia y Prevención Cardiovascular de la Federación Argentina de Cardiologia; Argentina
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Fil: Lamelas, Pablo. McMaster University; Canadá. Instituto Cardiovascular de Buenos Aires; Argentina
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Fil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; Argentina
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Fil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
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Fil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
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Fil: Pascual, Andrea. Estudios Clínicos Latino América; Argentina
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Fil: Rovito, Carla. Estudios Clínicos Latino América; Argentina
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Fil: Galatte, Agustina. Estudios Clínicos Latino América; Argentina
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Fil: Scarafia, Franco. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; Argentina
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Fil: Sued, Omar. Fundación Huésped; Argentina
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Fil: Gutierrez, Omar. Ministerio de Salud de Jujuy; Argentina
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Fil: Jolly, Sanjit S.. McMaster University; Canadá
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Fil: Miró, José M.. Universidad de Barcelona; España
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Fil: Eikelboom, John. McMaster University; Canadá
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Fil: Loeb, Mark. McMaster University; Canadá
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Fil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Italia
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Fil: Bhatt, Deepak L.. Brigham and Women’s Hospital; Estados Unidos. Harvard Medical School; Estados Unidos
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Fil: Yusuf, Salim. McMaster University; Canadá
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Fil: Lopez, Lorena. No especifíca;
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Fil: Leon de la Fuente, Ricardo Alfonso. Gobierno de la Provincia de Salta. Ministerio de Salud Pública. Hospital Papa Francisco; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Forciniti, Cristian C. G.. No especifíca;
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Fil: Colombo, Hugo. No especifíca;
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Fil: Sabas, Nicolas. No especifíca;
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Fil: Pilón, Leonardo. No especifíca;
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Fil: Steren, Adriana P.. No especifíca;
dc.journal.title
JAMA Network Open
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1001/jamanetworkopen.2021.41328
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info:eu-repo/semantics/altIdentifier/url/https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787585
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