Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04326790
Previous Study | Return to List | Next Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326790
Recruitment Status : Terminated (Slow enrollment as a result of the rapid flattening of the curve of COVID-19 cases in Greece)
First Posted : March 30, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Spyridon Deftereos, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE March 30, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE April 3, 2020
Actual Primary Completion Date April 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • 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)
  • Maximal concentration of cardiac troponin [ Time Frame: 10 days ]
    Maximal concentration of high-sensitivity cardiac troponin
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • CRP increase [ Time Frame: 2 weeks ]
    Time to increase in C-reactive protein to 3 times the ULN
  • Clinical endpoint [ Time Frame: 2 weeks ]
    Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Official Title  ICMJE The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patient-level randomization scheme
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Corona Virus Disease 19 (Covid 19)
Intervention  ICMJE
  • Drug: Colchicine
    Low-dose colchicine treatment, 0.5 mg bid
  • Drug: Standard treatment
    Standard treatment
Study Arms  ICMJE
  • Experimental: Intervention
    Colchicine, on top of standard treatment
    Interventions:
    • Drug: Colchicine
    • Drug: Standard treatment
  • Active Comparator: Control
    Standard treatment, including all medications recommedned by the National Public Health Organization
    Intervention: Drug: Standard treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2021)
105
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
180
Actual Study Completion Date  ICMJE April 27, 2020
Actual Primary Completion Date April 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries Gibraltar
 
Administrative Information
NCT Number  ICMJE NCT04326790
Other Study ID Numbers  ICMJE 906295542
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Spyridon Deftereos, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National and Kapodistrian University of Athens
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP