The Efficacy of Colchicine IN Sepsis: The COLINS Randomized Clinical Trial

Abstract

Background: Sepsis is a leading cause of mortality worldwide and is characterized by dysregulated inflammatory responses that contribute to multi-organ failure. Despite advances in supportive care, effective adjunctive anti-inflammatory therapies for sepsis remain limited. We aimed to determine whether colchicine, compared with placebo, improves inflammatory biomarkers and clinical outcomes in patients with sepsis.Methods: The COLINS trial was a double-blind, randomized, placebo-controlled trial conducted in patients with sepsis. Patients were randomly assigned in a 1:1 ratio to receive colchicine (1 mg once daily) or a matched placebo for 10 days. Of 72 patients screened, 50 were randomized, and 44 completed the study. The primary outcome was the change in the IL-6 levels at day 4. Secondary outcomes included the change in procalcitonin at day 4, the SOFA score at days 4 and 10, 28-day mortality, the duration of mechanical ventilation, and the number of vasopressor-free days during study period. Results: The mean age of patients was 48.4 years, and 18.2% were women. There was no significant difference in the IL-6 levels at day 4 between the colchicine group and the placebo group (P=0.42). Change in SOFA score at day 4 was significantly greater in the colchicine group than in the placebo group (P=0.02). Also, SOFA score at day 10 was significantly lower in the colchicine group (P<0.01). The number of ventilator-needed days was significantly lower in the colchicine group (P=0.04). We found no difference between colchicine and placebo in the procalcitonin level at day 4 (P=0.53), vasopressor-free days (P=0.13), or 28-day mortality (P=0.74).Conclusion: In patients with sepsis, treatment with colchicine, significantly reduced the risk of multi-organ failure and increased ventilator-free days. However, there was no significant difference between two groups in the number of vasopressor-free days or mortality.

Keywords: Sepsis, Colchicine, COLINS trial, Anti-inflammatory, SOFA score