The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Overview

Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

Interventions

  • Drug: Colchicine
    • Low-dose colchicine treatment, 0.5 mg bid
  • Drug: Standard treatment
    • Standard treatment

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Colchicine, on top of standard treatment
  • Active Comparator: Control
    • Standard treatment, including all medications recommedned by the National Public Health Organization

Clinical Trial Outcome Measures

Primary Measures

  • Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
    • Time Frame: 3 weeks
    • Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
  • Maximal concentration of cardiac troponin
    • Time Frame: 10 days
    • Maximal concentration of high-sensitivity cardiac troponin

Participating in This Clinical Trial

Inclusion Criteria

Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg.

Exclusion Criteria

  • pregnancy, lactation;
  • known hypersensitivity to colchicine
  • known hepatic failure
  • eGFR<20 ml/min
  • clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
  • any clinical estimation of the attending physician under which the patient shall be excluded
  • QTc > 450 msec (colchicine is not known to significantly prolong QTc, but may interact with other medications which prolong QTc).
  • participation in another clinical trial
  • under colchicine treatment for other indications
  • patient who is not likely to comply to study procedures

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National and Kapodistrian University of Athens
  • Provider of Information About this Clinical Study
    • Principal Investigator: Spyridon Deftereos, Professor of Cardiology – National and Kapodistrian University of Athens
  • Overall Contact(s)
    • Spyridon Deftereos, 00306944699901, spdeftereos@gmail.com

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