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

Corona Virus Disease 19 (Covid 19) Clinical Trial

— GRECCO-19  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04326790
• Other study ID #: 906295542
• Status: Terminated
• Phase: Phase 2
• Start date: April 3, 2020
• Est. completion date: April 27, 2020

Study information

• Verified date: April 2021
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Disease 19 (Covid 19)
• Virus Diseases

Intervention

Drug:
• Colchicine
Low-dose colchicine treatment, 0.5 mg bid
• Standard treatment
Standard treatment

Locations

Country	Name	City	State
Greece	National and Kapodistrian University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximal concentration of cardiac troponin	Maximal concentration of high-sensitivity cardiac troponin	10 days