6/28/23, 10:56 PM GRECCO-19 Pathway Feedback Search Clinical Topics Home Studies GRECCO 19 GRECCO 19 Disease COVID 19 infection Trial question What is the effect of colchicine in patients hospitalized with COVID-19? Study design Multi-center Open label RCT Population Characteristics of study participants 42.0% female N = 105 58.0% male 105 patients (44 female, 61 male) Inclusion criteria: patients hospitalized with COVID-19 Key exclusion criteria: pregnancy or lactation, known hypersensitivity to colchicine, known hepatic failure, eGFR < 20 mL/min/1.73 m , corrected QT interval > 450 milliseconds Interventions N=55 colchicine (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg BID with standard medical treatment for as long as 3 weeks) N=50 control (standard medical treatment) Primary outcome Time to clinical deterioration rate 14.0 % 14 10 5 % https://web.pathway.md/studies/recgB7LEatPrdQqd2 1/2 6/28/23, 10:56 PM 10.5 % GRECCO-19 Pathway 7.0 % Significant decrease 3.5 % NNT = 8 1.8 0.0 % Colchicine Control Significant decrease in time to clinical deterioration rate (1.8% vs. 14%; OR 0.11, 95% CI 0.01 to 0.96) Secondary outcomes Significant decrease in median maximum CRP levels (3.1 mg/dL vs. 4.5 mg/dL; AD -4.75 mg/dL, 95% CI -19.1 to -9.6) Significant decrease in median peak high-sensitivity cardiac troponin values (0.008 ng/mL vs. 0.011 ng/mL; AD -0.0017 ng/mL, 95% CI 0 to 0) Significant increase in the rate of cumulative event-free 10 day survival (97% vs. 83%; AD 14%, 95% CI 1.34 to 26.66) Safety outcomes No significant differences in adverse events, vomiting, diarrhea requiring study discontinuation, nausea, muscle spasm, headache. Significant difference in diarrhea (45.5% vs. 18.0%). Conclusion In patients hospitalized with COVID-19, colchicine was superior to control with respect to time to clinical deterioration rate. Reference Spyridon G Deftereos, Georgios Giannopoulos, Dimitrios A Vrachatis et al. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. Open reference URL https://web.pathway.md/studies/recgB7LEatPrdQqd2 2/2