The GReek study in the Effects of Colchicine in COvid-19 complications prevention (GRECCO-19 study): rationale and study design

ABSTRACT Background 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. Methods GRECCO-19 will be prospective, cluster randomized, open-labeled, controlled study. 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 Conclusions GRECCO-19 trial aims to identify whether colchicine may positively intervene in the clinical course of COVID-19. (The study has been submitted to clinicaltrials.gov on March 26, 2020)