Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial (Corrected Version)

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dc.contributor.authorDiaz, Rafael
dc.contributor.otherOrlandini, Andrés
dc.contributor.otherCastellana, Noelia
dc.contributor.otherCaccavo, Alberto
dc.contributor.otherCorral, Pablo
dc.contributor.otherCorral, Gonzalo
dc.contributor.otherChacón, Carolina
dc.contributor.otherLamelas, Pablo
dc.contributor.otherBotto, Fernando
dc.contributor.otherDíaz, María Luz
dc.contributor.otherDomínguez, Juan Manuel
dc.contributor.otherPascual, Andrea
dc.contributor.otherRovito, Carla
dc.contributor.otherGalatte, Agustina
dc.contributor.otherScarafia, Franco
dc.contributor.otherSued, Omar
dc.contributor.otherGutierrez, Omar
dc.contributor.otherJolly, Sanjit S
dc.contributor.otherMiró, Jose M
dc.contributor.otherEikelboom, John
dc.contributor.otherLoeb, Mark
dc.contributor.otherMaggioni, Aldo Pietro
dc.contributor.otherBhatt, Deepak L
dc.contributor.otherYusuf, Salim
dc.contributor.otherECLA PHRI COLCOVID Trial Investigators
dc.date.accessioned2024-05-23T23:49:14Z
dc.date.available2024-05-23T23:49:14Z
dc.date.issued2021-12-29
dc.descriptionFil: Diaz R. Estudios Clínicos Latino América, Rosario; Argentinaes_ES
dc.description.abstractImportance: 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. Trial registration: ClinicalTrials.gov Identifier: NCT04328480. Conflict of interest statementes_ES
dc.formatapplication/pdfes_ES
dc.identifier.doihttps://doi.org/10.1001/jamanetworkopen.2021.41328
dc.identifier.doihttps://doi.org/10.1001%2Fjamanetworkopen.2022.3150
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1329
dc.languageENGes_ES
dc.provenancePublishedes_ES
dc.relation.ispartofseriesJama Network Open;2021 Dec 1;4(12):e2141328.
dc.rightsopenAccesses_ES
dc.subjectClinical Triales_ES
dc.subjectCOVID-19es_ES
dc.titleEffect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial (Corrected Version)es_ES
dc.typeArticuloes_ES

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