6/28/23, 9:50 PM ECLA PHRI COLCOVID Pathway Feedback Search Clinical Topics Home Studies ECLA PHRI COLCOVID ECLA PHRI COLCOVID Disease COVID 19 infection 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 N = 1279 65.0% male 1279 patients (449 female, 830 male) Inclusion criteria: adults 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 28.8 % 28.8 25 https://web.pathway.md/studies/reca9yL6A6GsTRupr 1/2 6/28/23, 9:50 PM ECLA PHRI COLCOVID Pathway 21.6 % 14.4 % 7.2 % No significant difference 0.0 % Colchicine Usual care 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 adults 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, Andr s 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. Open reference URL https://web.pathway.md/studies/reca9yL6A6GsTRupr 2/2