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

• Status: Terminated
• Trial end date: 2020-04-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National and Kapodistrian University of Athens
• Treatments: Colchicine

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