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

National and Kapodistrian University of Athens

Status and phase: Terminated; Phase 2

Conditions: Corona Virus Disease 19 (Covid 19)

Treatments: Drug: Colchicine; Drug: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04326790

906295542

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Intervention

Experimental group

Description:

Colchicine, on top of standard treatment

Treatment:

Drug: Colchicine

Drug: Standard treatment

Control

Active Comparator group

Description:

Standard treatment, including all medications recommedned by the National Public Health Organization

Treatment:

Drug: Standard treatment