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

Primary Purpose

Corona Virus Disease 19 (Covid 19)

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Colchicine
Standard treatment
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Disease 19 (Covid 19)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National and Kapodistrian University of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Colchicine, on top of standard treatment

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

Outcomes

Primary Outcome Measures

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)
Maximal concentration of cardiac troponin
Maximal concentration of high-sensitivity cardiac troponin

Secondary Outcome Measures

Full Information

First Posted
March 26, 2020
Last Updated
April 2, 2021
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04326790
Brief Title
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Acronym
GRECCO-19
Official Title
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Disease 19 (Covid 19)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patient-level randomization scheme
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Colchicine, on top of standard treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard treatment, including all medications recommedned by the National Public Health Organization
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Low-dose colchicine treatment, 0.5 mg bid
Intervention Type
Drug
Intervention Name(s)
Standard treatment
Intervention Description
Standard treatment
Primary Outcome Measure Information:
Title
Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee
Description
Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
Time Frame
3 weeks
Title
Maximal concentration of cardiac troponin
Description
Maximal concentration of high-sensitivity cardiac troponin
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
National and Kapodistrian University of Athens
City
Athens
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34658014
Citation
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Results Reference
derived
PubMed Identifier
32579195
Citation
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, Martinez-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.
Results Reference
derived
PubMed Identifier
32251729
Citation
Deftereos SG, Siasos G, Giannopoulos G, Vrachatis DA, Angelidis C, Giotaki SG, Gargalianos P, Giamarellou H, Gogos C, Daikos G, Lazanas M, Lagiou P, Saroglou G, Sipsas N, Tsiodras S, Chatzigeorgiou D, Moussas N, Kotanidou A, Koulouris N, Oikonomou E, Kaoukis A, Kossyvakis C, Raisakis K, Fountoulaki K, Comis M, Tsiachris D, Sarri E, Theodorakis A, Martinez-Dolz L, Sanz-Sanchez J, Reimers B, Stefanini GG, Cleman M, Filippou D, Olympios CD, Pyrgakis VN, Goudevenos J, Hahalis G, Kolettis TM, Iliodromitis E, Tousoulis D, Stefanadis C. The Greek study in the effects of colchicine in COvid-19 complications prevention (GRECCO-19 study): Rationale and study design. Hellenic J Cardiol. 2020 Jan-Feb;61(1):42-45. doi: 10.1016/j.hjc.2020.03.002. Epub 2020 Apr 3.
Results Reference
derived

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

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