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

April 2, 2021 updated by: Spyridon Deftereos, National and Kapodistrian University of Athens
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • National and Kapodistrian University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Colchicine, on top of standard treatment
Drug: Colchicine
Low-dose colchicine treatment, 0.5 mg bid
Drug: Standard treatment
Standard treatment
Active Comparator: Control
Standard treatment, including all medications recommedned by the National Public Health Organization
Drug: Standard treatment
Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
Time Frame: 3 weeks
Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
3 weeks
Maximal concentration of cardiac troponin
Time Frame: 10 days
Maximal concentration of high-sensitivity cardiac troponin
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Actual)

April 27, 2020

Study Completion (Actual)

April 27, 2020

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 906295542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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