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

Sponsor
National and Kapodistrian University of Athens (Other)
Overall Status
Terminated
CT.gov ID
NCT04326790
Collaborator
(none)
105
1
2
24
133.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patient-level randomization schemePatient-level randomization scheme
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Actual Study Start Date :
Apr 3, 2020
Actual Primary Completion Date :
Apr 27, 2020
Actual Study Completion Date :
Apr 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Colchicine, on top of standard treatment

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

Drug: Standard treatment
Standard treatment

Active Comparator: Control

Standard treatment, including all medications recommedned by the National Public Health Organization

Drug: Standard treatment
Standard treatment

Outcome Measures

Primary Outcome Measures

  1. Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee [3 weeks]

    Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)

  2. Maximal concentration of cardiac troponin [10 days]

    Maximal concentration of high-sensitivity cardiac troponin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National and Kapodistrian University of Athens Athens Greece

Sponsors and Collaborators

  • National and Kapodistrian University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spyridon Deftereos, Professor of Cardiology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier:
NCT04326790
Other Study ID Numbers:
  • 906295542
First Posted:
Mar 30, 2020
Last Update Posted:
Apr 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021