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    Summary
    EudraCT Number:2021-000417-16
    Sponsor's Protocol Code Number:Uni-Köln-4480
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-01
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2021-000417-16
    A.3Full title of the trial
    A Phase I / randomized Phase II trial to analyse safety and efficacy of human SARS-CoV 2 specific T lymphocyte transfer in patients with COVID-19 in need of treatment or at risk of severe COVID-19
    Eine Phase I-Studie / randomisierte Phase II-Studie zur Prüfung der Sicherheit und Wirksamkeit des Transfers von humanen SARS-CoV-2-spezifischen T Lymphozyten in Patienten mit behandlungsbedürftiger COVID-19 Erkrankung oder dem Risiko eines schweren Verlaufs der COVID-19 Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test the safety and efficacy of a new drug (human immune cells against COVID-19, administered intravenously) for patients with COVID-19 in need of treatment or at risk for severe COVID-19
    Eine Studie zur Bewertung der Sicherheit und Wirksamkeit eines neuen Medikaments ( bestehend aus menschlichen Immunzellen gegen SARS-CoV-2, intravenös verabreicht) für behandlungsbedürftige Patienten mit einer COVID-19 Erkrankung oder dem Risiko eines schweren Verlaufs der COVID-19 Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    ACT-COVID19
    ACT-COVID19
    A.4.1Sponsor's protocol code numberUni-Köln-4480
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04762186
    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 SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    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 supportState government of North Rhine Westphalia
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTC Cologne
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Str. 269
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number0049221478 88125
    B.5.5Fax number0049221478 88209
    B.5.6E-mailulrike.zettelmeyer@uk-koeln.de
    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 namehuman SARS-CoV-2 specific T lymphocytes
    D.3.2Product code SUB222337
    D.3.4Pharmaceutical form 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 INNhuman SARS-CoV-2 specific T lymphocytes
    D.3.9.2Current sponsor codehuman SARS-CoV-2-specific T lymphocytes
    D.3.9.3Other descriptive nameAllogeneic SARS-CoV-2-specific CD4+ and CD8+ T lymphocytes
    D.3.9.4EV Substance CodeSUB222337
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Patients who are tested positive for SARS-CoV-2 by PCR from upper or lower respiratory sites and are at increased risk for developing critical disease presenting with moderate disease
    -WHO ordinal scale 4 with at least one additional risk factor for disease progression
    or
    -WHO ordinal scale 5
    Patienten mit positivem PCR Test auf SARS-CoV-2 aus den oberen oder unteren Atemwegen, die ein erhöhtes Risiko für die Entwicklung einer schweren Erkrankung haben:
    -WHO-Ordinalskala 4, mit mindestens einem Risikofaktoren für einen schweren Verlauf
    oder
    -WHO-Ordinalskala 5
    E.1.1.1Medical condition in easily understood language
    COVID-19 in patients at risk of severe COVID-19 disease progression
    COVID-19 bei Patienten mit Risiko eines schweren Verlaufs der COVID-19 Erkrankung
    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 LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I part:
    • To determine the recommended phase II dose (RP2D) of viable human SARS-CoV-2-specific T lymphocytes by evaluation of safety and tolerability

    Phase II part:
    • To gain first data on efficacy of human SARS-CoV-2-specific T lymphocytes therapy
    Phase I Teil:
    • Bestimmung der empfohlenen Phase-II-Dosis (RP2D) von lebensfähigen humanen SARS-CoV-2-spezifischen T Lymphozyten durch Bewertung der Sicherheit und Verträglichkeit

    Phase II-Teil:
    • Gewinnung erster Daten zur Wirksamkeit der humanen SARS-CoV-2-spezifischen T Lymphozyten Therapie
    E.2.2Secondary objectives of the trial
    Phase I part:
    • To gain first data on biological activity of viable human SARS-CoV2-specific T lymphocyte therapy
    • To assess the feasibility of production of viable human SARS-CoV-2-specific T lymphocytes from convalescent donors with a HLA match of ≥ 2/6 loci and < 10/10
    Phase II part:
    • Evaluation of safety and tolerability of a single administration of viable human SARS-CoV-2-specific
    T lymphocytes
    • Overall survival (OS) of patients treated with viable human SARS-CoV-2-specific T lymphocytes (until day 100)
    • Effect of viable human SARS-CoV-2 –specific T lymphocytes infusion on viral shedding in nasooropharyngeal swabs
    • Characterization of efficacy with respect to the course of disease
    Phase I Teil:
    • Gewinnung erster Therapiedaten zur biologischen Aktivität lebensfähiger humaner SARS-CoV2-spezifischen T-Lymphozyten
    • Beurteilung der Machbarkeit der Herstellung von lebensfähigen humanen SARS-CoV-2-spezifischen T Lymphozyten von rekonvaleszenten Spendern mit einer HLA-Übereinstimmung von ≥ 2/6 loci and < 10/10
    Phase II Teil:
    • Bewertung der Sicherheit und Verträglichkeit einer einmaligen Verabreichung von lebensfähigen humanen SARS-CoV-2-spezifischen T Lymphozyten
    • Gesamtüberleben (OS) der mit lebensfähigen humanen SARS-CoV-2-spezifischen T Lymphozyten behandelten Patienten (bis Tag 100)
    • Wirkung der Infusion lebensfähiger humaner SARS-CoV-2 -spezifischer T-Lymphozyten auf die Virusausscheidung in nasooropharyngealen Abstrichen
    • Charakterisierung der Wirksamkeit in Bezug auf den Krankheitsverlauf
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For phase I and II
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent (participants ≥ 18 years of age)
    2. Willing to follow contraception guidelines
    3. Tested positive for SARS-CoV-2 by PCR <72 hours prior to inclusion
    4. A maximum of 14 days between onset of symptoms and
    enrollment
    5. WHO score 4 with at least one additional risk factor for disease progression
    Acceptable risk factors are:
    a. Radiographically proven lung infiltrates
    b. Immunosuppression either by malignant disease or its treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
    c. Immunosuppressive drugs, including steroids at a prednisolone equivalent of <1 mg/kg BW. 6mg dexamethasone per os or intravenous 1x/d (SOC) are allowed, but are not considered as inclusion criterion in the sense of immunosuppressive treatment
    d. Receipt of an autologous transplant within the last 5 years
    e. Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression OR
    6. WHO score Score 5
    Für Phase I und II
    1. Fähigkeit, den Zweck und die Risiken der Studie zu verstehen und eine unterschriebene und datierte Einverständniserklärung abzugeben (Teilnehmer ≥ 18 Jahre alt)
    2. Bereitschaft zur Einhaltung der Verhütungsrichtlinien
    3. Positiv getestet auf SARS-CoV-2 durch PCR <72 Stunden vor Einschluss
    4. Maximal 14 Tage zwischen Auftreten der Symptome und Einschluss
    5. WHO-Score 4 mit mindestens einem zusätzlichen Risikofaktor für das Fortschreiten der Erkrankung
    Akzeptable Risikofaktoren sind:
    a. Röntgenologisch nachgewiesene Lungeninfiltrate
    b. Immunsuppression entweder durch eine bösartige Erkrankung oder deren Behandlung oder andere zugrundeliegende Erkrankungen, die zu einer Immunschwäche führen oder zugrundeliegende Erkrankungen, die eine Behandlung erfordern, die zu einer Immunsuppression führt
    c. Immunsuppressive Medikamente, einschließlich Steroide mit einem Prednisolonäquivalent von <1 mg/kg BW. 6mg Dexamethason per os oder intravenös 1x/d (SoC) sind erlaubt, gelten aber nicht als Einschlusskriterium im Sinne einer immunsuppressiven Behandlung
    d. Erhalt einer autologen Transplantation innerhalb der letzten 5 Jahre
    e. Erhalt eines allogenen Transplantats innerhalb der letzten 5 Jahre oder laufende Immunsuppression ODER
    6. WHO-Score Punktzahl 5
    E.4Principal exclusion criteria
    For phase I and II
    1. Participation in any other clinical trial of an experimental agent treatment
    2. Active or history of GvHD
    3. History of CAR-T-Cell Therapy
    4. COVID-19 WHO ordinal scale ≥6
    5. Anticipated life-expectancy <72 hours
    6. Expected duration of hospital stay <72 hours
    7. Sepsis-induced leukopenia or thrombocytopenia (leukocytes <1000/µl or platelets <50.000/µl). If the cytopenias result from underlying hematologic disease or its treatment, this will not be
    regarded as exclusion criterion.
    8. CT pneumonia score ≥13, if CT has been performed as SoC
    9. Any other Steroids ≥ 1mg/kg Prednisolon-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
    10. Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
    11. Known hypersensitivity to iron dextran
    12. Known pre-existing human anti-mouse antibodies (HAMAs)
    13. Contraindication against mandatory protocol-inherent comedication(s): antihistamine and/or
    acetaminophen
    14. Pregnant or breast feeding
    15. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject’s safe participation in and completion of the study
    Für Phase I und II Teil:
    1. Teilnahme an einer anderen klinischen Studie mit einem experimentellen Wirkstoff
    2. aktive GvHD oder bekannte abgelaufenen GvHD
    3. Bekannte CAR-T-Zell Therapie
    4. COVID-19 WHO-Ordinalskala ≥6
    5. Voraussichtliche Lebenserwartung <72 Stunden
    6. Erwartete Dauer des Krankenhausaufenthalts <72 Stunden
    7. Sepsis-induzierte Leukopenie oder Thrombozytopenie (Leukozyten <1000/µl oder Thrombozyten <50.000/µl). Wenn die Zytopenien aus einer hämatologischen Grunderkrankung oder deren Behandlung resultieren, wird dies nicht als nicht als Ausschlusskriterium betrachtet.
    8. CT-Pneumonie-Score ≥13, wenn ein CT im Rahmen des SoC durchgeführt wurde
    9. Alle anderen Steroide ≥ 1mg/kg Prednisolon-Äquivalent/kg KG, außer 6mg Dexamethason i.v. oder p.o. 1x/d, im Rahmen der Standardbehandlung bei COVID-19
    10. Therapeutische Spender-Lymphozyten-Infusion (DLI) weniger als 100 Tage vor der IMP-Infusion
    11. Bekannte Überempfindlichkeit gegen Eisendextran
    12. Bekannte vorbestehende humane Anti-Maus-Antikörper (HAMAs)
    13. Kontraindikation gegen obligatorische(s) protokollinterne(s) Komedikation(en): Antihistaminikum und/oder Paracetamol
    14. Schwangere oder Stillende
    15. Jeder schwerwiegende medizinische Zustand oder jede Anomalie bei klinischen Labortests, der/die nach dem Urteil des Prüfers die sichere Teilnahme des Probanden an der Studie und deren Abschluss ausschließt.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I
    • Dose-limiting toxicities until day 28 after infusion of viable human SARS-CoV-2- specific T lymphocytes
    Phase II
    • AUC of the course of disease measured by the WHO ordinal scale for COVID-19
    Phase I
    • Dosislimitierende Toxizitäten bis Tag 28 nach Infusion von lebensfähigen humanen SARS-CoV-2- spezifischen T Lymphozyten
    Phase II
    • AUC des Krankheitsverlaufs gemessen an der WHO-Ordinalskala für COVID-19
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see protocol section 4.8.
    Siehe Protokoll Kapitel 4.8.
    E.5.2Secondary end point(s)
    Phase I
    • Safety outcome measures: The rate and severity of adverse events after infusion of viable human SARS-CoV-2- specific T lymphocytes during the trial.
    • Clinical manifestations of acute Graft-versus–Host Disease (GvHD) until day 100 after administration of IMP
    • T lymphocyte count manufactured/archieved
    • Number of patients with IMP and dose received
    • Clinical status as assessed on the WHO ordinal scale
    • Hospitalization duration in days
    • Duration of SARS-CoV-2 PCR positivity (in days) from nasooropharyngeal swabs until discharge or death
    • Detection of viable human SARS-CoV-2-specific T lymphocyte after infusion
    • Effect of viable human SARS-CoV-2–specific T lymphocyte infusion on viral shedding in nasooropharyngeal swabs

    Phase II
    • Clinical status as assessed on the WHO ordinal scale
    • Overall survival (OS)
    • Incidence of ICU admission after randomization
    • Time to ventilation (noninvasive ventilation, high-flow oxygen, invasive ventilation or ECMO)
    • Duration of use of oxygen (in days) after randomization until discharge or death
    • Incidence and duration (in days) of new use of noninvasive ventilation
    • Incidence and duration (in days) of new use of noninvasive ventilation after randomization until discharge or death
    • Incidence and duration (in days) of new use of high-flow oxygen
    • Incidence and duration (in days) of use of high-flow oxygen after randomization until discharge or death
    • Incidence and duration (in days) of new use of invasive ventilation or ECMO
    • Incidence and duration (in days) of new use of invasive ventilation or ECMO after randomization until discharge or death
    • Hospitalization duration in days
    • Safety outcome measures: The rate and severity of adverse events after infusion of viable human SARS-CoV-2-specific T lymphocytes during the trial.
    • Clinical manifestations of acute GvHD until Day 100
    • Duration of SARS-CoV-2 PCR positivity (in days) from nasooropharyngeal swabs until discharge or death.

    Explorative endpoints phase I
    • Overall survival (OS) of patients treated with viable human SARS-CoV-2-specific T lymphocytes.
    • Characterization of efficacy with respect to the course of disease

    Exploratory endpoints in both phases:
    • NLR (neutrophil to lymphocyte ratio) at inclusion and during treatment
    Immunomonitoring:
    • Phenotype of T-lymphocytes (memory/effector phenotype, exhaustion, activation)
    • Viable SARS-CoV-2-specific T cells of donor and recipient origin
    • Duration of persistence of viable human SARS-CoV-2- specific T lymphocytes in the recipient’s blood circulation
    • SARS-CoV-2-specific B cells and antibody production
    • CRS soluble factors and cytokines
    Phase I
    • Messgrößen zur Sicherheit: Die Rate und der Schweregrad von unerwünschten Ereignissen nach der Infusion von lebensfähigen humanen SARS-CoV-2-spezifischen T Lymphozyten während der Studie.
    • Klinische Manifestationen der akuten Graft-versus-Host Disease (GvHD) bis Tag 100 nach Verabreichung des IMP
    • Hergestellte/erzielte Zahl an T-Lymphozyten
    • Anzahl der Patienten mit IMP und erhaltener Dosis
    • Klinischer Status, bewertet nach der WHO-Ordinalskala
    • Dauer des Krankenhausaufenthalts in Tagen
    • Dauer der SARS-CoV-2 PCR-Positivität (in Tagen) von nasooropharyngealen Abstrichen bis zur Entlassung oder zum Tod
    • Nachweis von lebensfähigen humanen SARS-CoV-2-spezifischen T-Lymphozyten nach Infusion
    • Wirkung der lebensfähigen humanen SARS-CoV-2-spezifischen T-Lymphozyten-Infusion auf die virale Ausscheidung in nasooropharyngealem Abstrich

    Phase II
    • Klinischer Status, bewertet nach der WHO-Ordinalskala
    • Gesamtüberleben (OS)
    • Inzidenz der Aufnahme auf einer Intensivstation nach Randomisierung
    • Zeit bis zur Beatmung (nicht-invasive Beatmung, High-Flow-Sauerstoff, invasive Beatmung oder ECMO)
    • Dauer der Verwendung von Sauerstoff (in Tagen) nach Randomisierung bis zur Entlassung oder zum Tod
    • Häufigkeit und Dauer (in Tagen) der erneuten Anwendung von nicht-invasiver Beatmung
    • Häufigkeit und Dauer (in Tagen) des erneuten Einsatzes von nicht-invasiver Beatmung nach Randomisierung bis zur Entlassung oder zum Tod
    • Häufigkeit und Dauer (in Tagen) des erneuten Einsatzes von High-Flow-Sauerstoff
    • Häufigkeit und Dauer (in Tagen) des Einsatzes von High-Flow-Sauerstoff nach Randomisierung bis zur Entlassung oder zum Tod
    • Inzidenz und Dauer (in Tagen) der erneuten Anwendung von invasiver Beatmung oder ECMO
    • Häufigkeit und Dauer (in Tagen) des erneuten Einsatzes von invasiver Beatmung oder ECMO nach der Randomisierung bis zur Entlassung oder zum Tod
    • Dauer des Krankenhausaufenthalts in Tagen
    • Messgrößen zur Sicherheit: Häufigkeit und Schweregrad von unerwünschten Ereignissen nach Infusion von lebensfähigen humanen SARS-CoV-2-spezifischen T-Lymphozyten während der Studie.
    • Klinische Manifestationen der akuten GvHD bis Tag 100
    • Dauer der SARS-CoV-2 PCR-Positivität (in Tagen) von nasooropharyngealen Abstrichen bis zur Entlassung oder zum Tod.

    Explorative Endpunkte in Phase I
    • Gesamtüberleben von Patienten, die mit lebensfähigen humanen SARS-CoV-2-spezifischen T-Lymphozyten behandelt wurden.
    • Charakterisierung der Wirksamkeit in Bezug auf den Krankheitsverlauf

    Explorative Endpunkte in beiden Phasen:
    • NLR (Verhältnis von Neutrophilen zu Lymphozyten) bei Einschluss und während der Behandlung
    Immunmonitoring:
    • Phänotyp der T-Lymphozyten (Gedächtnis-/Effektor-Phänotyp, Erschöpfung, Aktivierung)
    • Lebensfähige SARS-CoV-2-spezifische T-Zellen von Spender und Empfänger
    • Dauer der Persistenz lebensfähiger humaner SARS-CoV-2-spezifischen T Lymphozyten im Blutkreislauf des Empfängers
    • SARS-CoV-2-spezifische B-Zellen und Antikörperproduktion
    • CRS-lösliche Faktoren und Zytokine
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see protocol section 4.8.
    Siehe Protokoll Kapitel 4.8.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Phase I: monozentrisch offen, Phase II: multizentrisch, randomisiert, IMP+SoC gegen SoC
    Phase I: monocentric open label, Phase II: multi-centre, randomized, IMP+SoC versus SoC
    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
    In Phase II: IMP+SoC gegen SoC
    In Phase II: IMP+SoC versus SoC
    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 concerned7
    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
    LVLS
    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 months3
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state51
    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)
    not applicable
    Nicht zutreffend
    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 Decision2021-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-03
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