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

Study Overview
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Brief Summary
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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.

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

Conditions
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Corona Virus Disease 19 (Covid 19)

Intervention / Treatment
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* Drug: Colchicine
* Drug: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient-level randomization scheme
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Colchicine, on top of standard treatment | Drug: Colchicine<br>* Low-dose colchicine treatment, 0.5 mg bid<br>Drug: Standard treatment<br>* Standard treatment<br>|
| Active Comparator: Control<br>Standard treatment, including all medications recommedned by the National Public Health Organization | Drug: Standard treatment<br>* Standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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