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

Phase 2

Terminated

• Conditions: Corona Virus Disease 19 (Covid 19)
• Interventions: Drug: Standard treatment; Drug: Colchicine

• Registration Number: NCT04326790
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Study Start: 2020-04-03
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard treatment	Standard treatment, including all medications recommedned by the National Public Health Organization
Intervention	Standard treatment	Colchicine, on top of standard treatment
Intervention	Colchicine	Colchicine, on top of standard treatment

Primary Outcome Measures

Name	Time	Method
Maximal concentration of cardiac troponin	10 days	Maximal concentration of high-sensitivity cardiac troponin
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)

Trial Locations

Locations (1)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece