The Greek Study in the Effects of Colchicine in COvid-19 Complications Prevention (GRECCO-19 Study): Rationale and Study Design.

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. (C) 2020 Hellenic Society of Cardiology. Publishing services by Elsevier B.V.