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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

Deftereos SG, Giannopoulos G, MD, Vrachatis DA, et. al. on behalf of the GRECCO-19 investigators. JAMA Network Open. 2020;3(6):e2013136. doi:10.1001/jamanetworkopen.2020.13136

Key Points:

GRECCO-19 (Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention) is a randomized study involving 16 tertiary care centers in Greece who randomized 105 patients to standard medical care vs. colchicine treatment in the setting of COVID – 19 care.

  • Study Goal: To assess the potential benefit of colchicine treatment to reduce cardiac inflammatory biomarkers and clinical outcomes in hospitalized patients with COVID – 19.
  • Colchicine Dosing: Loading – colchicine 1.5 mg followed by 0.5 mg at 1 hour. Maintenance dose – 0.5 mg twice daily. Dose duration: Up to 3 weeks.
  • Population: Patients – 105; Male – 60 (58.1%); Median Age – 64 (range 54-76); Control Patients – 50 (47.6%), Colchicine Group – 55 (52.4%). [All median ranges expressed as interquartile ranges]
  • Biomarker Results:
    • Median maximum high-sensitivity troponin levels: Control patients – 0.0112 (0.0043-0.0193); Colchicine Group – 0.008 (0.004-0.0135) P=0.34 [Values expressed as ng/ml]
    • Median maximum C-reactive protein levels: Control patients – 4.5 (1.4-8.9);
    • Colchicine Group – 3.1 (0.8-9.8) P=0.73 [Values expressed as mg/dl].
  • Clinical Results:
    • Time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death: Control Group – 7/50 (14%); Colchicine Group – 1/55 (1.8%) [Odds ratio 0.11; 95% CI, 0.01-0.96; P=0.02]
    • Mean (SD) event Free Survival: Control Group – 18.6 days (0.83) days; Colchicine Group – 20.7 (0.31) [log rank P=0.03]
    • D-dimer (Not a prespecified study value): Control Group – 0.92 (0.68 – 2.77); Colchicine Group – (0.76 (0.41 – 1.59) μg/mL [P = .04].
  • Adverse Events: There were no significant differences between groups except for more frequent diarrhea in the Colchicine Group
  • Limitations: No control of other medications or management with patients enrolled in variable additional drug therapy trials including azithromycin and hydroxychloroquine as well as other drugs. Likewise, there were variations in anticoagulation strategies.
  • Conclusions:
    • Colchicine provided a clinical benefit in a small patient population without a prospective biomarker benefit; However, a retrospective evaluation showed significantly lower levels D-dimer levels for colchicine patients suggesting a potential anti-inflammatory effect on an recognized COVID – 19, high risk biomarker.
    • These results should be considered hypothesis generating.