Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial
- Autores
- Diaz, Rafael; Orlandini, Andrés; Castellana, Noelia; Caccavo, Alberto; Corral, Pablo; Corral, Gonzalo; Chacón, Carolina; Lamelas, Pablo; Botto, Fernando; Díaz, María Luz; Domínguez, Juan Manuel; Pascual, Andrea; Rovito, Carla; Galatte, Agustina; Scarafia, Franco; Sued, Omar; Gutierrez, Omar; Jolly, Sanjit S.; Miró, José M.; Eikelboom, John; Loeb, Mark; Maggioni, Aldo Pietro; Bhatt, Deepak L.; Yusuf, Salim; Lopez, Lorena; Leon de la Fuente, Ricardo Alfonso; Forciniti, Cristian C. G.; Colombo, Hugo; Sabas, Nicolas; Pilón, Leonardo; Steren, Adriana P.
- Año de publicación
- 2022
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- 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. Instituto Cardiovascular de Rosario; Argentina
Fil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
Fil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; Argentina
Fil: Caccavo, Alberto. Provincia de Buenos Aires. Dirección General de Cultura y Educación. Universidad Provincial del Sudoeste; Argentina
Fil: Corral, Pablo. Universidad FASTA "Santo Tomas de Aquino"; Argentina
Fil: Corral, Gonzalo. Infectología Clínica de Mayo; Argentina
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
Fil: Lamelas, Pablo. McMaster University; Canadá. Instituto Cardiovascular de Buenos Aires; Argentina
Fil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; Argentina
Fil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina
Fil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina. 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. Universidad Nacional de Rosario; Argentina
Fil: Sued, Omar. Fundación Huésped; Argentina
Fil: Gutierrez, Omar. Ministerio de Salud de Jujuy; Argentina
Fil: Jolly, Sanjit S.. McMaster University; Canadá
Fil: Miró, José M.. Universidad de Barcelona; España
Fil: Eikelboom, John. McMaster University; Canadá
Fil: Loeb, Mark. McMaster University; Canadá
Fil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Italia
Fil: Bhatt, Deepak L.. Brigham and Women’s Hospital; Estados Unidos. Harvard Medical School; Estados Unidos
Fil: Yusuf, Salim. McMaster University; Canadá
Fil: Lopez, Lorena. No especifíca;
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
Fil: Forciniti, Cristian C. G.. No especifíca;
Fil: Colombo, Hugo. No especifíca;
Fil: Sabas, Nicolas. No especifíca;
Fil: Pilón, Leonardo. No especifíca;
Fil: Steren, Adriana P.. No especifíca; - Materia
-
Colchicina
COVID-19
Mortalidad
Complicaciones - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/240767
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Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical TrialDiaz, RafaelOrlandini, AndrésCastellana, NoeliaCaccavo, AlbertoCorral, PabloCorral, GonzaloChacón, CarolinaLamelas, PabloBotto, FernandoDíaz, María LuzDomínguez, Juan ManuelPascual, AndreaRovito, CarlaGalatte, AgustinaScarafia, FrancoSued, OmarGutierrez, OmarJolly, Sanjit S.Miró, José M.Eikelboom, JohnLoeb, MarkMaggioni, Aldo PietroBhatt, Deepak L.Yusuf, SalimLopez, LorenaLeon de la Fuente, Ricardo AlfonsoForciniti, Cristian C. G.Colombo, HugoSabas, NicolasPilón, LeonardoSteren, Adriana P.ColchicinaCOVID-19MortalidadComplicacioneshttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Importance 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. Instituto Cardiovascular de Rosario; ArgentinaFil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; ArgentinaFil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; ArgentinaFil: Caccavo, Alberto. Provincia de Buenos Aires. Dirección General de Cultura y Educación. Universidad Provincial del Sudoeste; ArgentinaFil: Corral, Pablo. Universidad FASTA "Santo Tomas de Aquino"; ArgentinaFil: Corral, Gonzalo. Infectología Clínica de Mayo; ArgentinaFil: 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; ArgentinaFil: Lamelas, Pablo. McMaster University; Canadá. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; ArgentinaFil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; ArgentinaFil: Pascual, Andrea. Estudios Clínicos Latino América; ArgentinaFil: Rovito, Carla. Estudios Clínicos Latino América; ArgentinaFil: Galatte, Agustina. Estudios Clínicos Latino América; ArgentinaFil: Scarafia, Franco. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; ArgentinaFil: Sued, Omar. Fundación Huésped; ArgentinaFil: Gutierrez, Omar. Ministerio de Salud de Jujuy; ArgentinaFil: Jolly, Sanjit S.. McMaster University; CanadáFil: Miró, José M.. Universidad de Barcelona; EspañaFil: Eikelboom, John. McMaster University; CanadáFil: Loeb, Mark. McMaster University; CanadáFil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; ItaliaFil: Bhatt, Deepak L.. Brigham and Women’s Hospital; Estados Unidos. Harvard Medical School; Estados UnidosFil: Yusuf, Salim. McMaster University; CanadáFil: Lopez, Lorena. No especifíca;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; ArgentinaFil: Forciniti, Cristian C. G.. No especifíca;Fil: Colombo, Hugo. No especifíca;Fil: Sabas, Nicolas. No especifíca;Fil: Pilón, Leonardo. No especifíca;Fil: Steren, Adriana P.. No especifíca;American Medical Association2022-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/240767Diaz, 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; 1-122574-3805CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1001/jamanetworkopen.2021.41328info:eu-repo/semantics/altIdentifier/url/https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787585info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:44:40Zoai:ri.conicet.gov.ar:11336/240767instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:44:40.885CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
dc.title.none.fl_str_mv |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
title |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
spellingShingle |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial Diaz, Rafael Colchicina COVID-19 Mortalidad Complicaciones |
title_short |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
title_full |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
title_fullStr |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
title_full_unstemmed |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
title_sort |
Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized with COVID-19: A Randomized Clinical Trial |
dc.creator.none.fl_str_mv |
Diaz, Rafael Orlandini, Andrés Castellana, Noelia Caccavo, Alberto Corral, Pablo Corral, Gonzalo Chacón, Carolina Lamelas, Pablo Botto, Fernando Díaz, María Luz Domínguez, Juan Manuel Pascual, Andrea Rovito, Carla Galatte, Agustina Scarafia, Franco Sued, Omar Gutierrez, Omar Jolly, Sanjit S. Miró, José M. Eikelboom, John Loeb, Mark Maggioni, Aldo Pietro Bhatt, Deepak L. Yusuf, Salim Lopez, Lorena Leon de la Fuente, Ricardo Alfonso Forciniti, Cristian C. G. Colombo, Hugo Sabas, Nicolas Pilón, Leonardo Steren, Adriana P. |
author |
Diaz, Rafael |
author_facet |
Diaz, Rafael Orlandini, Andrés Castellana, Noelia Caccavo, Alberto Corral, Pablo Corral, Gonzalo Chacón, Carolina Lamelas, Pablo Botto, Fernando Díaz, María Luz Domínguez, Juan Manuel Pascual, Andrea Rovito, Carla Galatte, Agustina Scarafia, Franco Sued, Omar Gutierrez, Omar Jolly, Sanjit S. Miró, José M. Eikelboom, John Loeb, Mark Maggioni, Aldo Pietro Bhatt, Deepak L. Yusuf, Salim Lopez, Lorena Leon de la Fuente, Ricardo Alfonso Forciniti, Cristian C. G. Colombo, Hugo Sabas, Nicolas Pilón, Leonardo Steren, Adriana P. |
author_role |
author |
author2 |
Orlandini, Andrés Castellana, Noelia Caccavo, Alberto Corral, Pablo Corral, Gonzalo Chacón, Carolina Lamelas, Pablo Botto, Fernando Díaz, María Luz Domínguez, Juan Manuel Pascual, Andrea Rovito, Carla Galatte, Agustina Scarafia, Franco Sued, Omar Gutierrez, Omar Jolly, Sanjit S. Miró, José M. Eikelboom, John Loeb, Mark Maggioni, Aldo Pietro Bhatt, Deepak L. Yusuf, Salim Lopez, Lorena Leon de la Fuente, Ricardo Alfonso Forciniti, Cristian C. G. Colombo, Hugo Sabas, Nicolas Pilón, Leonardo Steren, Adriana P. |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.subject.none.fl_str_mv |
Colchicina COVID-19 Mortalidad Complicaciones |
topic |
Colchicina COVID-19 Mortalidad Complicaciones |
purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.2 https://purl.org/becyt/ford/3 |
dc.description.none.fl_txt_mv |
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. Instituto Cardiovascular de Rosario; Argentina Fil: Orlandini, Andrés. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina Fil: Castellana, Noelia. Estudios Clínicos Latino América; Argentina. Universidad Nacional de Rosario; Argentina Fil: Caccavo, Alberto. Provincia de Buenos Aires. Dirección General de Cultura y Educación. Universidad Provincial del Sudoeste; Argentina Fil: Corral, Pablo. Universidad FASTA "Santo Tomas de Aquino"; Argentina Fil: Corral, Gonzalo. Infectología Clínica de Mayo; Argentina 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 Fil: Lamelas, Pablo. McMaster University; Canadá. Instituto Cardiovascular de Buenos Aires; Argentina Fil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; Argentina Fil: Díaz, María Luz. Estudios Clínicos Latino América; Argentina. Instituto Cardiovascular de Rosario; Argentina Fil: Domínguez, Juan Manuel. Estudios Clínicos Latino América; Argentina. 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. Universidad Nacional de Rosario; Argentina Fil: Sued, Omar. Fundación Huésped; Argentina Fil: Gutierrez, Omar. Ministerio de Salud de Jujuy; Argentina Fil: Jolly, Sanjit S.. McMaster University; Canadá Fil: Miró, José M.. Universidad de Barcelona; España Fil: Eikelboom, John. McMaster University; Canadá Fil: Loeb, Mark. McMaster University; Canadá Fil: Maggioni, Aldo Pietro. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center; Italia Fil: Bhatt, Deepak L.. Brigham and Women’s Hospital; Estados Unidos. Harvard Medical School; Estados Unidos Fil: Yusuf, Salim. McMaster University; Canadá Fil: Lopez, Lorena. No especifíca; 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 Fil: Forciniti, Cristian C. G.. No especifíca; Fil: Colombo, Hugo. No especifíca; Fil: Sabas, Nicolas. No especifíca; Fil: Pilón, Leonardo. No especifíca; Fil: Steren, Adriana P.. No especifíca; |
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. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-05 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
http://hdl.handle.net/11336/240767 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 2574-3805 CONICET Digital CONICET |
url |
http://hdl.handle.net/11336/240767 |
identifier_str_mv |
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 2574-3805 CONICET Digital CONICET |
dc.language.none.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/doi/10.1001/jamanetworkopen.2021.41328 info:eu-repo/semantics/altIdentifier/url/https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787585 |
dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
eu_rights_str_mv |
openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
American Medical Association |
publisher.none.fl_str_mv |
American Medical Association |
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reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
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dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
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13.070432 |