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    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001455-40
    Sponsor's Protocol Code Number:GRECCO-19
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2020-001455-40
    A.3Full title of the trial
    The Greek study in the Effects of Colchicine in Covid-19 complications prevention
    ΧΟΡΗΓΗΣΗ ΚΟΛΧΙΚΙΝΗΣ ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ CORONAVIRUS DISEASE-19 (COVID-19) ΓΙΑ ΤΗΝ ΠΡΟΛΗΨΗ ΕΞΕΛΙΞΗΣ ΚΑΙ ΤΩΝ ΕΠΙΠΛΟΚΩΝ ΤΗΣ ΝΟΣΟΥ – Η ΜΕΛΕΤΗ GRECCO-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study using colchicine for preventing the complications from Covid-19
    A.3.2Name or abbreviated title of the trial where available
    GRECCO-19
    A.4.1Sponsor's protocol code numberGRECCO-19
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04326790
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHellenic Society of Rhythmology
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportELPEN
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHellenic Society of Rhythmology
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street Address6 Leof. Poseidonos, Elliniko
    B.5.3.2Town/ cityAthens
    B.5.3.4CountryGreece
    B.5.6E-maildvrachatis@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Colchicine
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameColchicine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLCHICINE
    D.3.9.1CAS number 64-86-8
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This trial will investigate if colchicine could potentially have an effect in patients’ clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients with COVID-19 often suffers from myocardial necrosis and this trial will study if these patients will have a benefit by receiving colchicine
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to address the question 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.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (under RT PCR) and clinical status that involves body temperature >37.5 oC
    AND
    2. at least two out of the:
    i. sustained coughing,
    ii. sustained throat pain,
    iii. anosmia and/or ageusia,
    iv. fatigue/tiredness,
    v. PaO2<95 mmHg.
    E.4Principal exclusion criteria
    1. Pregnancy, breastfeeding, or unwillingness to take effective contraceptive methods in men and women of reproductive ability during the clinical trial
    2. Hypersensitivity in Colchicine or in any of the excipients of the product (lactose, gum arabic, sucrose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, methylene casein, erythrosine lacquer).
    3. Serious hepatic failure
    4. eGFR<20 ml/min/1.73m2
    5. Clinical estimation that the patient will require mechanical respiratory support in less than 24 hours.
    6. Any clinical estimation of the attending physician under which the patient shall be excluded
    7. QTc > 450 msec.
    8. Participation in a clinical trial with a research product (medication or device) or intervention.
    9. Being treated with colchicine for other indications.
    10. A person who, at the discretion of the Researcher, is unable to comply with or participate in the clinical trial may place it at unacceptable health risks.
    11. A person undergoing haemodialysis
    12. Severe gastrointestinal failure, severe gastrointestinal disorder, or stomach ulcer
    13. Hematological disorders, such as blood disease
    14. Under treatment or 14 days after use of P-glycoprotein inhibitors or CYP3A4 enzyme inhibitors
    E.5 End points
    E.5.1Primary end point(s)
    Biochemical Phase:
    1. Difference in maximum high-sensitivity troponin (hs-cTn) within 10 days from treatment initiation
    2. Time for CRP levels that exceeds > 3xUNL

    Clinical Phase:
    1. Time to clinical deterioration (criterion: 2 levels in WHO R&D Blueprint scale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    E.5.2Secondary end point(s)
    Biochemical Phase:
    1. The number, the type, the severity and the seriousness of Adverse Events (AE) and the AE related to therapy until the end of monitoring.

    Clinical Phase:
    1. Percentage of patients who will require mechanical ventilation in every visit
    2. Mortality by any cause at the end of monitoring
    3. The number, the type, the severity and the seriousness of Adverse Events (AE) and the AE related to therapy until the end of monitoring.
    4. Function Lung Tests in healed patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The trial will end when data will be analysed and close out visits on sites will be performed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 126
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
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