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    Summary
    EudraCT Number:2020-001623-13
    Sponsor's Protocol Code Number:T3inj-02/Thy-Support
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-22
    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 number2020-001623-13
    A.3Full title of the trial
    Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study)
    Η τριϊωδοθυρονίνη για την θεραπεία των σοβαρά νοσούντων ασθενών με λοίμωξη από COVID-19 (μελέτη Thy-Support)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study)
    Η τριϊωδοθυρονίνη για την θεραπεία των σοβαρά νοσούντων ασθενών με λοίμωξη από COVID-19 (μελέτη Thy-Support)
    A.3.2Name or abbreviated title of the trial where available
    Thy-Support STUDY
    ΜΕΛΕΤΗ Thy-Support
    A.4.1Sponsor's protocol code numberT3inj-02/Thy-Support
    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 SponsorUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
    B.5.2Functional name of contact pointIoulia Tseti
    B.5.3 Address:
    B.5.3.1Street Address14th km National Road 1
    B.5.3.2Town/ cityΚifissia
    B.5.3.3Post code145 64
    B.5.3.4CountryGreece
    B.5.4Telephone number00302108072512
    B.5.5Fax number00302108078907
    B.5.6E-mailunipharma@uni-pharma.gr
    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 No
    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 nameT3® Solution for injection 10 μg/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIOTHYRONINE SODIUM
    D.3.9.1CAS number 55-06-1
    D.3.9.4EV Substance CodeSUB02931MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO
    Βαρέως πάσχοντες ασθενείς που νοσηλεύονται σε ΜΕΘ λόγω λοίμωξης από COVID19 και χρειάζονται μηχανική αναπνευστική υποστήριξη
    E.1.1.1Medical condition in easily understood language
    ICU patients diagnosed with pulmonary infection due to COVID-19
    Βαρέως πάσχοντες ασθενείς που νοσηλεύονται σε ΜΕΘ λόγω λοίμωξης από COVID19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus 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 primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo.
    Ο πρωταρχικός στόχος της μελέτης είναι να προσδιορίσει εάν η χορήγηση ενδοφλεβίως τριιωδοθυρονίνης σε ασθενείς που θα διαγνωσθούν με αναπνευστική λοίμωξη από COVID-19 σε κρίσιμη κατάσταση διευκολύνει τον απογαλακτισμό από την καρδιοαναπνευστική υποστήριξη σε σχέση με την ομάδα του εικονικού φαρμάκου.
    E.2.2Secondary objectives of the trial
    1.Assessment of hemodynamic status
    2.Assessment of pulmonary function
    3.Assessment of hepatic and renal function
    4.Assessment of cardiac function
    5.Assessment of the course of COVID-19 infection
    6.Assessment of clinical outcome and safety
    1.Εκτίμηση της αιμοδυναμικής κατάστασης
    2.Εκτίμηση της αναπνευστικής λειτουργίας
    3.Εκτίμηση της ηπατικής και νεφρικής λειτουργίας
    4.Εκτίμηση της καρδιακής λειτουργίας
    5.Εκτίμηση της πορείας της λοίμωξης από COVID-19
    6.Εκτίμηση του κλινικού αποτελέσματος και της ασφάλειας
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients diagnosed with pulmonary infection due to COVID-19, admitted
    in ICU and require mechanical ventilation or ECMO
    •Male and female with Age>18 years old
    •Signed informed consent from patient or relatives
    •Ασθενείς που θα διαγνωσθούν με αναπνευστική λοίμωξη από COVID-19, θα εισαχθούν σε ΜΕΘ και χρειάζονται αναπνευστήρα ή ECMO
    •Άντρες και γυναίκες ηλικίας >18 ετών
    •Υπογραφή εντύπου συγκατάθεσης
    E.4Principal exclusion criteria
    •Pregnant or breast-feeding women
    •Severe systemic disease (e.g. cancer) before infection accompanied by reduced life expectancy <6 months
    •Participation in another trial of an investigational drug or device
    •Κύηση ή θηλασμός
    •Σοβαρή συστηματική νόσος (π.χ.καρκίνος) πριν από τη λοίμωξη που συνοδεύεται από μειωμένο προσδόκιμο επιβίωσης <6 μήνες
    •Συμμετοχή σε άλλη κλινική μελέτη ελέγχου φαρμάκου ή συσκευής

    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is expected in 15% of patients in placebo group. We assume that T3 treatment can increase successful weaning to 50% of patients which is a significant clinical improvement in prognosis.
    Το κύριο καταληκτικό σημείο της αποτελεσματικότητας θα είναι το ποσοστό των ασθενών που βγήκαν από τη τεχνητή αναπνευστική υποστήριξη σε σύγκριση με την ομάδα placebo.
    Επιτυχής απογαλακτισμός από την τεχνητή αναπνευστική υποστήριξη αναμένεται σε 15% των ασθενών στην ομάδα του εικονικού φαρμάκου (placebo group). Αναμένουμε οτι η θεραπεία με Τ3 μπορεί να αυξήσει τον επιτυχή απογαλακτισμό σε 50% που αποτελεί μια πολύ σημαντική βελτίωση της πρόγνωσης.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment period will last till successful weaning or end of follow-up. Follow up will be performed for 1 month.
    H περίοδος χορήγησης του φαρμάκου θα διαρκέσει μέχρι τον επιτυχή απογαλακτισμό ή μέχρι το τέλος της παρακολούθησης. Η περίοδος παρακολούθησης θα διαρκέσει 1 μήνα.
    E.5.2Secondary end point(s)
    NA
    Δεν εφαρμόζεται
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    Δεν εφαρμόζεται
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    LVLS
    Τελευταία Επίσκεψη Τελευταίου Ασθενούς
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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 Decision2020-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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