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

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.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04328480.

• Authors: Rafael Diaz, Andrés Orlandini, Noelia Castellana, Alberto Caccavo, Pablo Corral, Gonzalo Corral, Carolina Chacón, Pablo Lamelas, Fernando Botto, María Luz Díaz, Juan Manuel Domínguez, Andrea Pascual, Carla Rovito, Agustina Galatte, Franco Scarafia, Omar Sued, Omar Gutierrez, Sanjit S Jolly, José M Miró, John Eikelboom, Mark Loeb, Aldo Pietro Maggioni, Deepak L Bhatt, Salim Yusuf, ECLA PHRI COLCOVID Trial Investigators
• Journal: JAMA network open (JAMA Netw Open) Vol. 4 Issue 12 Pg. e2141328 (12 01 2021) ISSN: 2574-3805 [Electronic] United States
• PMID: 34964849 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Anti-Inflammatory Agents
• Colchicine

Topics

• Adrenal Cortex Hormones (therapeutic use)
• Adult
• Aged
• Anti-Inflammatory Agents (adverse effects, therapeutic use)
• COVID-19 (mortality, pathology, therapy)
• Colchicine (adverse effects, therapeutic use)
• Female
• Hospitalization
• Humans
• Inflammation (drug therapy, etiology)
• Intubation, Intratracheal
• Male
• Middle Aged
• Respiration, Artificial
• SARS-CoV-2
• Standard of Care