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

Terminated
Corona Virus Disease 19 (Covid 19)

Drug: Colchicine

Low-dose colchicine treatment, 0.5 mg bid

Drug: Standard treatment

Standard treatment

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Greece
Locations

National and Kapodistrian University of Athens
Athens, Greece

National and Kapodistrian University of Athens
NCT Number
MeSH Terms
COVID-19
Virus Diseases
Colchicine