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

Hellenic J Cardiol. 2020 Jan-Feb;61(1):42-45. doi: 10.1016/j.hjc.2020.03.002. Epub 2020 Apr 3.

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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / adverse effects
  • Betacoronavirus / isolation & purification
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods
  • Colchicine* / administration & dosage
  • Colchicine* / adverse effects
  • Coronavirus Infections* / complications
  • Coronavirus Infections* / diagnosis
  • Coronavirus Infections* / physiopathology
  • Heart Diseases* / blood
  • Heart Diseases* / etiology
  • Heart Diseases* / prevention & control
  • Humans
  • Pandemics*
  • Pneumonia, Viral* / complications
  • Pneumonia, Viral* / diagnosis
  • Pneumonia, Viral* / physiopathology
  • Randomized Controlled Trials as Topic
  • SARS-CoV-2
  • Symptom Assessment / methods
  • Troponin / analysis

Substances

  • Antirheumatic Agents
  • Troponin
  • Colchicine

Associated data

  • ClinicalTrials.gov/NCT04326790