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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326790
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Spyridon Deftereos, National and Kapodistrian University of Athens

Brief 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.

Condition or disease Intervention/treatment Phase
Corona Virus Disease 19 (Covid 19) Drug: Colchicine Drug: Standard treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient-level randomization scheme
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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




Primary Outcome Measures :
  1. 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)

  2. Maximal concentration of cardiac troponin [ Time Frame: 10 days ]
    Maximal concentration of high-sensitivity cardiac troponin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326790


Contacts
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Contact: Spyridon Deftereos 00306944699901 spdeftereos@gmail.com

Locations
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Gibraltar
AHEPA Hospital Recruiting
Thessaloniki, Gibraltar
Sponsors and Collaborators
National and Kapodistrian University of Athens
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinèz-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.

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Responsible Party: Spyridon Deftereos, Professor of Cardiology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04326790    
Other Study ID Numbers: 906295542
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents