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    Original Investigation
    Infectious Diseases
    June 24, 2020

    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

    Spyridon G. Deftereos, MD, PhD1; Georgios Giannopoulos, MD, PhD2; Dimitrios A. Vrachatis, MD, MSc, PhD3; et al Gerasimos D. Siasos, MD, MSc, PhD4; Sotiria G. Giotaki, MD1; Panagiotis Gargalianos, MD, PhD5; Simeon Metallidis, MD, PhD6; George Sianos, MD, PhD7; Stefanos Baltagiannis, MD, MSc8; Periklis Panagopoulos, MD, PhD9; Konstantinos Dolianitis, MD, MSc10; Efthalia Randou, MD11; Konstantinos Syrigos, MD, PhD12; Anastasia Kotanidou, MD, PhD13; Nikolaos G. Koulouris, MD, PhD14; Haralampos Milionis, MD, PhD15; Nikolaos Sipsas, MD, PhD16; Charalampos Gogos, MD, PhD17; George Tsoukalas, MD, PhD18; Christoforos D. Olympios, MD, PhD19; Eleftheria Tsagalou, MD, PhD20; Ilias Migdalis, MD, PhD21; Styliani Gerakari, MD22; Christos Angelidis, MD1; Dimitrios Alexopoulos, MD, PhD1; Pericles Davlouros, MD, PhD23; George Hahalis, MD, PhD23; Ioannis Kanonidis, MD, PhD24; Demosthenes Katritsis, MD, PhD25; Theofilos Kolettis, MD, PhD26; Antonios S. Manolis, MD, PhD4; Lampros Michalis, MD, PhD26; Katerina K. Naka, MD, PhD26; Vlasios N. Pyrgakis, MD, PhD2; Konstantinos P. Toutouzas, MD, PhD4; Filippos Triposkiadis, MD, PhD27; Konstantinos Tsioufis, MD, PhD4; Emmanouil Vavouranakis, MD, PhD28; Luis Martinèz-Dolz, MD, PhD29; Bernhard Reimers, MD3; Giulio G. Stefanini, MD, MSc, PhD3; Michael Cleman, MD, PhD30; John Goudevenos, MD, PhD26; Sotirios Tsiodras, MD, PhD31; Dimitrios Tousoulis, MD, PhD4; Efstathios Iliodromitis, MD, PhD1; Roxana Mehran, MD, PhD32; George Dangas, MD, PhD32; Christodoulos Stefanadis, MD, PhD4,5; on behalf of the GRECCO-19 investigators
    Author Affiliations
    • 1Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece
    • 2Department of Cardiology, G. Gennimatas General Hospital of Athens, Athens, Greece
    • 3Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy
    • 4First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece
    • 5Athens Medical Center, Athens, Greece
    • 6First Department of Internal Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece
    • 7First Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece
    • 8Department of Internal Medicine, General Hospital of Kastoria, Kastoria, Greece
    • 9Second Department of Internal Medicine, General Hospital of Alexandroupoli, Democritus University of Thrace, Alexandroupoli, Greece
    • 10Department of Internal Medicine, Mpodosakio General Hospital of Ptolemaida, Ptolemaida, Greece
    • 11Department of Internal Medicine, General Hospital of Kozani, Kozani, Greece
    • 12Third Department of Internal Medicine, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece
    • 13First Intensive Care Unit, General Hospital Evangelismos, National and Kapodistrian University of Athens, Athens, Greece
    • 14First Department of Pneumonology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece
    • 15First Department of Internal Medicine, Ioannina University Hospital, University of Ioannina, Ioannina, Greece
    • 16Infectious Diseases Unit, Laiko General Hospital, Athens, Greece
    • 17Internal Medicine Department, University Hospital of Patras, Patras, Greece
    • 18Fourth Department of Pneumonology, General Hospital Sotiria, Athens, Greece
    • 19Department of Cardiology, General Hospital of Elefsina Thriasio, Elefsina, Greece
    • 20Therapeutics Department, Alexandra Hospital, Athens, Greece
    • 21Second Medical Department, NIMTS Hospital, Athens, Greece
    • 22Department of Internal Medicine, General Hospital of West Attica Agia Varvara, Athens, Greece
    • 23Department of Cardiology, University of Patras Medical School, Patras, Greece
    • 24Second Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece
    • 25Third Department of Cardiology, Hygeia Hospital, Athens, Greece
    • 26Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece
    • 27Department of Cardiology, University General Hospital of Larissa, Larissa, Greece
    • 28Third Department of Cardiology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece
    • 29Hospital Universitario y Politécnico La Fe, Valencia, Spain
    • 30Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
    • 31Fourth Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece
    • 32Icahn School of Medicine at Mount Sinai, New York, New York
    JAMA Netw Open. 2020;3(6):e2013136. doi:10.1001/jamanetworkopen.2020.13136
    Key Points español 中文 (chinese)

    Question  Is the receipt of colchicine among patients hospitalized with symptomatic coronavirus disease 2019 associated with clinical benefit?

    Findings  In this randomized clinical trial of 105 patients, the rate of the primary clinical end point (clinical deterioration) was higher in the control group than in the colchicine group, and the time to clinical deterioration was shorter in the control group than in the colchicine arm. No difference was observed in the primary biochemical end point (high-sensitivity troponin concentration), but patients in the colchicine group had a smaller increase in dimerized plasma fragment D compared with patients in the control group.

    Meaning  The hypothesis-generating findings of this study suggest a role for colchicine in the treatment of patients with coronavirus disease 2019.

    Abstract

    Importance  Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile.

    Objective  To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19).

    Design, Setting, and Participants  In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece.

    Intervention  Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks.

    Main Outcomes and Measures  Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis.

    Results  A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003).

    Conclusions and Relevance  In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution.

    Trial Registration  ClinicalTrials.gov Identifier: NCT04326790

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