The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design
Spyridon Deftereos, Gerasimos Siasos, Γεώργιος Γιαννόπουλος, Dimitrios A. Vrachatis, Christos Angelidis, Sotiria G. Giotaki, Panagiotis Gargalianos, Helen Giamarellou, Charalampos Gogos, Georgios Daikos, Marios Lazanas, Παγώνα Λάγιου, Georgios Saroglou, Nikolaos V. Sipsas, Sotirios Tsiodras, Dimitrios Chatzigeorgiou, Nikolaos Moussas, Αναστασία Κοτανίδου, Νikolaos Koulouris, Evangelos Oikonomou, Andreas Kaoukis, Charalampos Kossyvakis, Konstantinos Raisakis, Katerina Fountoulaki, Mihalis Comis, Dimitris Tsiachris, Eleni Sarri, Andreas Theodorakis, Luis Martínez‐Dolz, Jorge Sanz‐Sánchez, Bernhard Reimers, Giulio Stefanini, Michael Cleman, Dimitrios Filippou, Christoforos Olympios, Vlasios Pyrgakis, John Goudevenos, George Hahalis, Theofilos M. Kolettis, Efstathios K. 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).