The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design

Spyridon G Deftereos, Gerasimos Siasos, Georgios Giannopoulos, Dimitrios A Vrachatis, Christos Angelidis, Sotiria G Giotaki, Panagiotis Gargalianos, Helen Giamarellou, Charalampos Gogos, Georgios Daikos, Marios Lazanas, Pagona Lagiou, Georgios Saroglou, Nikolaos Sipsas, Sotirios Tsiodras, Dimitrios Chatzigeorgiou, Nikolaos Moussas, Anastasia Kotanidou, Nikolaos Koulouris, Evangelos Oikonomou, Andreas Kaoukis, Charalampos Kossyvakis, Konstantinos Raisakis, Katerina Fountoulaki, Mihalis Comis, Dimitrios Tsiachris, Eleni Sarri, Andreas Theodorakis, Luis Martinez-Dolz, Jorge Sanz-Sánchez, Bernhard Reimers, Giulio G Stefanini, Michael Cleman, Dimitrios Filippou, Christoforos D Olympios, Vlasios N Pyrgakis, John Goudevenos, George Hahalis, Theofilos M Kolettis, Efstathios Iliodromitis, Dimitrios Tousoulis, Christodoulos Stefanadis, Spyridon G Deftereos, Gerasimos Siasos, Georgios Giannopoulos, Dimitrios A Vrachatis, Christos Angelidis, Sotiria G Giotaki, Panagiotis Gargalianos, Helen Giamarellou, Charalampos Gogos, Georgios Daikos, Marios Lazanas, Pagona Lagiou, Georgios Saroglou, Nikolaos Sipsas, Sotirios Tsiodras, Dimitrios Chatzigeorgiou, Nikolaos Moussas, Anastasia Kotanidou, Nikolaos Koulouris, Evangelos Oikonomou, Andreas Kaoukis, Charalampos Kossyvakis, Konstantinos Raisakis, Katerina Fountoulaki, Mihalis Comis, Dimitrios Tsiachris, Eleni Sarri, Andreas Theodorakis, Luis Martinez-Dolz, Jorge Sanz-Sánchez, Bernhard Reimers, Giulio G Stefanini, Michael Cleman, Dimitrios Filippou, Christoforos D Olympios, Vlasios N Pyrgakis, John Goudevenos, George Hahalis, Theofilos M Kolettis, Efstathios Iliodromitis, Dimitrios Tousoulis, Christodoulos Stefanadis

Abstract

Objective: Colchicine has been utilized safely in a variety of cardiovascular clinical conditions. Among its potential mechanisms of action is the non-selective inhibition of NLRP3 inflammasome which is thought to be a major pathophysiologic component in the clinical course of patients with COVID-19. GRECCO-19 will be a prospective, randomized, open-labeled, controlled study to assess the effects of colchicine in COVID-19 complications prevention.

Methods: Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical picture that involves temperature >37.5 oC and at least two out of the: i. sustained coughing, ii. sustained throat pain, iii. Anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg will be included. Patients will be randomised (1:1) in colchicine or control group.

Results: Trial results will be disseminated through peer-reviewed publications and conference presentations.

Conclusion: GRECCO-19 trial aims to identify whether colchicine may positively intervene in the clinical course of COVID-19. (ClinicalTrials.gov Identifier: NCT04326790).

Keywords: COVID; CRP; Cardiac; Complications; Troponin.

Conflict of interest statement

Conflict of interest No conflict of interest exists.

Copyright © 2020 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.

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Graphical abstract
Graphical abstract

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