ECLA PHRI COLCOVID
Trial question
What is the role of colchicine in hospitalized patients with COVID-19 pneumonia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 1279
1279 patients (449 female, 830 male).
Inclusion criteria: adult patients hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome.
Key exclusion criteria: clear indications or contraindications for colchicine; CKD; negative results on a reverse transcription-PCR test for COVID-19.
Interventions
N=640 colchicine (oral loading dose of 1.5 mg followed by 0.5 mg after 2 hours and 0.5 mg 2 times for 14 days or until discharge).
N=639 usual care (local standard of care).
Primary outcome
Mechanical ventilation or death at day 28
25%
28.8%
28.8 %
21.6 %
14.4 %
7.2 %
0.0 %
Colchicine
Usual
care
No significant
difference ↔
No significant difference in mechanical ventilation or death at day 28 (25% vs. 28.8%; HR 0.83, 95% CI 0.67 to 1.02).
Secondary outcomes
No significant difference in death at day 28 (20.5% vs. 22.2%; HR 0.88, 95% CI 0.7 to 1.12).
Significant decrease in new intubation or death from respiratory failure at day 28 (22.3% vs. 27.1%; HR 0.79, 95% CI 0.63 to 0.99).
No significant difference in death from respiratory failure at day 28 (16.9% vs. 19.6%; HR 0.83, 95% CI 0.64 to 1.07).
Safety outcomes
No significant difference in other adverse events.
Significant difference in severe diarrhea (11.3% vs. 4.5%).
Conclusion
In adult patients hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome, colchicine was not superior to usual care with respect to mechanical ventilation or death at day 28.
Reference
Rafael Diaz, Andrés Orlandini, Noelia Castellana 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. JAMA Netw Open. 2021 Dec 1;4(12):e2141328.
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