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

Phase 2TerminatedNCT04326790

National and Kapodistrian University of Athens105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Corona Virus Disease 19 (Covid 19)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 3 weeks

Maximal concentration of cardiac troponin

Maximal concentration of high-sensitivity cardiac troponin

Time frame: 10 days