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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2022-000642-16
    Sponsor's Protocol Code Number:H4COVID
    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:2022-02-16
    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 number2022-000642-16
    A.3Full title of the trial
    Hydrogen sulfate guided therapy with STS for COVID-19 patients in need of critical care: The H4COVID open-label, randomized, triple-arm trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improvement of severe respiratory failure in Covid-19 patients
    Βελτίωση της αναπνευστικής ανεπάρκειας σε ασθενείς με Covid-19
    A.4.1Sponsor's protocol code numberH4COVID
    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 Institute for the Study of Sepsis
    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 supportHellenic Institute for the Study of Sepsis
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHellenic Institute for the Study of Sepsis
    B.5.2Functional name of contact pointPresident of the Board
    B.5.3 Address:
    B.5.3.1Street Address88 Michalakopoulou Street
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11528
    B.5.3.4CountryGreece
    B.5.4Telephone number00302107480662
    B.5.5Fax number00302107480662
    B.5.6E-mailinsepsis@otenet.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 Yes
    D.2.1.1.1Trade name NATRIUM THIOSULFAT 25%
    D.2.1.1.2Name of the Marketing Authorisation holderDR. F. KÖHLER CHEMIE
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNATRIUMTHIOSULFAT 25%
    D.3.4Pharmaceutical form Solution for infusion
    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 INNSODIUM THIOSULFATE
    D.3.9.1CAS number 7772-98-7
    D.3.9.3Other descriptive nameSODIUM THIOSULFATE
    D.3.9.4EV Substance CodeSUB15332MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Assessment of clinical improvement of critically ill patients with confirmed Covid-19 by administering of sodium thiosulfate
    Αξιολόγηση κλινικής βελτίωσης ασθενών σε κρίσιμη κατάσταση με επιβεβαιωμένο Covid-19 με χορήγηση θειοθειικού νατρίου
    E.1.1.1Medical condition in easily understood language
    Covid-19 Infection
    Λοίμωξη Covid-19
    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 10084268
    E.1.2Term COVID-19
    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
    It has been described that in patients with critical COVID-19 disease with ARDS in the Intensive Care Unit there is significant hydrogen sulfide (H2S) deficiency. H2S exerts significant anti-inflammatory effects while competing with IL-6. Sodium thiosulfate (STS) is a known H2S donor available for intravenous administration used for to treat cyanide poisoning and the side effects of cisplatin and is being investigated for its cardioprotective effect in patients with myocardial infarction. The aim of this study is to determine whether administration of sodium thiosulfate as a slow-release hydrogen sulfide donor could improve the outcome of critically ill patients with confirmed COVID-19.
    Έχει περιγραφεί ότι σε ασθενείς με κρίσιμη νόσο COVID-19 με ARDS στη Μονάδα Εντατικής Θεραπείας υπάρχει σημαντική ανεπάρκεια υδρόθειου (H2S). Το H2S ασκεί σημαντικές αντιφλεγμονώδεις επιδράσεις ενώ ανταγωνίζεται την IL-6. Το θειοθειικό νάτριο (STS) είναι ένας γνωστός δότης H2S διαθέσιμος για ενδοφλέβια χορήγηση που χρησιμοποιείται για τη θεραπεία της δηλητηρίασης από κυάνιο και των παρενεργειών της σισπλατίνης και διερευνάται για την καρδιοπροστατευτική του δράση σε ασθενείς με έμφραγμα του μυοκαρδίου. Ο στόχος αυτής της μελέτης είναι να προσδιοριστεί εάν η χορήγηση θειοθειικού νατρίου ως δότης βραδείας αποδέσμευσης υδρόθειου θα μπορούσε να βελτιώσει την έκβαση των ασθενών σε κρίσιμη κατάσταση με επιβεβαιωμένο COVID-19.
    E.2.2Secondary objectives of the trial
    A secondary purpose is to describe data on the clinical efficacy of administration of up to three doses of STS in critically ill patients with confirmed COVID-19.
    Ένας δευτερογενής σκοπός είναι η περιγραφή δεδομένων σχετικά με την κλινική αποτελεσματικότητα της χορήγησης έως και τριών δόσεων STS σε βαρέως πάσχοντες ασθενείς με επιβεβαιωμένο COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age equal to or older than 18 years
    -Both genders
    -For women of childbearing potential, they must use or be willing to use a dual contraceptive method during the study.
    -Written consent statement provided by the patient or his / her legal representative in case patients are unable to consent.
    -Confirmed COVID-19 disease
    -WHO-CPS 7 to 9
    -Hospitalization in Intensive Care Unit
    -Serum H2S levels less than 140 μM
    -Ηλικία ίση ή μεγαλύτερη των 18 ετών
    -Και τα δύο φύλα
    -Για γυναίκες σε αναπαραγωγική ηλικία, πρέπει να χρησιμοποιούν ή να είναι πρόθυμες να χρησιμοποιήσουν μια διπλή μέθοδο αντισύλληψης κατά τη διάρκεια της μελέτης.
    -Γραπτή δήλωση συγκατάθεσης που παρέχεται από τον ασθενή ή τον νόμιμο εκπρόσωπό του σε περίπτωση που οι ασθενείς δεν μπορούν να συναινέσουν.
    -Επιβεβαιωμένη νόσος COVID-19
    -WHO-CPS 7 έως 9
    -Νοσηλεία σε Μονάδα Εντατικής Θεραπείας
    -Επίπεδα H2S ορού μικρότερα από 140 μM
    E.4Principal exclusion criteria
    -Age less than 18 years
    -Denial of written consent
    -Decision not to resuscitate
    -Ηλικία κάτω των 18 ετών
    -Άρνηση γραπτής συγκατάθεσης
    -Απόφαση για μη αναζωογόνηση
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of treatment-emergent serious and non-serious adverse events between treatment groups.
    Σύγκριση σοβαρών και μη σοβαρών ανεπιθύμητων ενεργειών που προκύπτουν από τη θεραπεία μεταξύ των ομάδων θεραπείας.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Ημέρα 28
    E.5.2Secondary end point(s)
    Comparison of treatment groups below:
    -WHO-CPS on day 7 from inclusion in the study
    -WHO-CPS on day 14 from inclusion in the study
    -WHO-CPS on day 28 of inclusion in the study
    -Average value of the total SOFA score on day 7
    -Hydrogen sulfide concentrations daily until day 7 in patient’s blood serum.
    -Cytokine concentrations daily until day 7 in patient’s blood serum.
    -Production of cytokines from mononuclear cells of patient’s blood on days 1,4 and 7
    Σύγκριση των παρακάτω ομάδων θεραπείας:
    -WHO-CPS την ημέρα 7 από την ένταξη στη μελέτη
    -WHO-CPS την ημέρα 14 από την ένταξη στη μελέτη
    -WHO-CPS την 28η ημέρα ένταξης στη μελέτη
    -Μέση τιμή της συνολικής βαθμολογίας SOFA την ημέρα 7
    -Συγκεντρώσεις υδρόθειου ημερησίως μέχρι την 7η ημέρα στον ορό αίματος του ασθενούς.
    -Συγκεντρώσεις κυτοκινών καθημερινά μέχρι την 7η ημέρα στον ορό αίματος του ασθενούς.
    -Παραγωγή κυτοκινών από μονοπύρηνα κύτταρα του αίματος του ασθενούς τις ημέρες 1, 4 και 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7
    Day 14
    Day 28
    Day 1-7
    Day 1,4,7
    Ημέρα 7
    Ημέρα 14
    Ημέρα 28
    Ημέρα 1-7
    Ημέρα 1,4,7
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    different dose of the same product
    E.8.2.4Number of treatment arms in the trial3
    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 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
    LVLS
    Τελευταία επίσκεψη (ημέρα 28) του τελευταίου ασθενούς που υποβλήθηκε στη δοκιμή
    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
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some of patients may be sedated under mechanical ventilation in the
    Intensive Care Unit. This condition makes impossible that they consent
    and consent needs to be asked by the legal representative
    Μερικοί ασθενείς μπορεί να βρίσκονται σε καταστολή υπό μηχανικό
    αερισμό. Αυτή η κατάσταση καθιστά μη εφικτή τη λήψη συναίνεσης από
    τους ίδιους οπότε και θα ζητηθεί συναίνεση από το νόμιμο εκπρόσωπο.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    Δεν εφαρμόζεται
    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 Decision2022-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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