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
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/240767

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repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling 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
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
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reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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