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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 Trial.
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.
  • Diaz R; Estudios Clínicos Latino América, Rosario, Argentina.
  • Orlandini A; Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Castellana N; Estudios Clínicos Latino América, Rosario, Argentina.
  • Caccavo A; Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Corral P; Estudios Clínicos Latino América, Rosario, Argentina.
  • Corral G; Universidad Nacional de Rosario, Rosario, Argentina.
  • Chacón C; Hospital de Coronel Suárez Raúl Alfredo Caccavo, Universidad Provincial del Sudoeste, Buenos Aires, Argentina.
  • Lamelas P; Departamento de Investigación, Facultad de Medicina, Universidad FASTA, Buenos Aires, Argentina.
  • Botto F; Infectología Clínica de Mayo, Mar del Plata, Argentina.
  • Díaz ML; Estudios Clínicos Latino América, Rosario, Argentina.
  • Domínguez JM; Universidad Abierta Interamericana, Rosario, Argentina.
  • Pascual A; Unidad Coronaria de Sanatorio Delta de Rosario, Rosario, Argentina.
  • Rovito C; Comite de Epidemiologia y Prevención Cardiovasculr de la Federación Argentina de Cardiologia, Rosario, Argentina.
  • Galatte A; Health Research Methods, Evidence, and Impact, Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
  • Scarafia F; Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
  • Sued O; Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
  • Gutierrez O; Estudios Clínicos Latino América, Rosario, Argentina.
  • Jolly SS; Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Miró JM; Estudios Clínicos Latino América, Rosario, Argentina.
  • Eikelboom J; Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Loeb M; Heart Failure and Heart Transplant Unit, Instituto Cardiovascular de Rosario, Rosario, Argentina.
  • Maggioni AP; Estudios Clínicos Latino América, Rosario, Argentina.
  • Bhatt DL; Estudios Clínicos Latino América, Rosario, Argentina.
  • Yusuf S; Estudios Clínicos Latino América, Rosario, Argentina.
JAMA Netw Open ; 4(12): e2141328, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1592856
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 11 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiration, Artificial / Colchicine / COVID-19 / Hospitalization / Intubation, Intratracheal / Anti-Inflammatory Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2021 Document Type: Article Affiliation country: Jamanetworkopen.2021.41328

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiration, Artificial / Colchicine / COVID-19 / Hospitalization / Intubation, Intratracheal / Anti-Inflammatory Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: JAMA Netw Open Year: 2021 Document Type: Article Affiliation country: Jamanetworkopen.2021.41328