GRECCO-19
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
58.0% male
N = 105
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 m², 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
1.8%
14%
14.0 %
10.5 %
7.0 %
3.5 %
0.0 %
Colchicine
Control
Significant
decrease ▼
NNH = 8
Significantly shorter 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.
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