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

Enrollment

Location

Arms

Actual Duration (Days)

133.2

Patients Per Site Per Month

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
Corona Virus Disease 19 (Covid 19)	Drug: Colchicine Drug: Standard treatment	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

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

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)
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:

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:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Virus Diseases

Colchicine

Study Results

No Results Posted as of Apr 6, 2021