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    Summary
    EudraCT Number:2021-005059-35
    Sponsor's Protocol Code Number:TMP-2204-2021-47
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-03-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-005059-35
    A.3Full title of the trial
    Potential of FX06 to prevent disease progression in hospitalised nonintubated COVID-19 patients (Ixion)
    Potenzialità di FX06 dil prevenire la progressione della malattia in pazienti affetti da COVID-19 ricoverati e non intubati (Ixion)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to prevent disease progression in hospitalised non-intubated COVID-19 patients by treatment with FX06
    IXION
    A.3.2Name or abbreviated title of the trial where available
    IXION
    IXION
    A.4.1Sponsor's protocol code numberTMP-2204-2021-47
    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 SponsorF4 PHARMA Gmbh
    B.1.3.4CountryAustria
    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 supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMarta Soler
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressC/ Ramiro de Maeztu 4, 1º2ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number646888722
    B.5.5Fax number646888722
    B.5.6E-mailsoler.es.cra@esaic.org
    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 nameFX06
    D.3.2Product code [FX06]
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFX06
    D.3.9.3Other descriptive nameFX06
    D.3.9.4EV Substance CodeSUB26822
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)
    sindrome respiratoria acuta grave da -Coronavirus-2 (SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    Moderate COVID-19 disease leading to hospitalisation but without need of intubation
    Pazienti affetti da Covid-19 ospedalizzati e non intubarti
    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 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    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
    The primary objective is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo until day 28.
    - Proportion of patients with worsened disease state until day 28 in both treatment groups

    Progression/worsening of disease state will be defined as a worsened WHO score on 3 consecutive days (always compared to the BL WHO score) until day 28 (e.g., a WHO score of 5 on 3 consecutive days for a patient that had a WHO score of 4 at BL will be defined as a worsened disease)
    L’obiettivo primario è dimostrare una differenza nella proporzione di pazienti con progressione/peggioramento dello stato della malattia tra i pazienti che ricevono FX06 e i pazienti che ricevono placebo fino al giorno 28.
    Proporzione di pazienti con peggioramento dello stato della malattia fino al giorno 28 in entrambi i gruppi di trattamento
    La progressione/il peggioramento dello stato della malattia sarà definito come un peggioramento del punteggio OMS [28] per 3 giorni consecutivi (sempre rispetto al punteggio OMS al basale) fino al giorno 28 (ad es., un punteggio OMS di 5 per 3 giorni consecutivi in un paziente che presentava un punteggio OMS di 4 al basale sarà considerato come un peggioramento dello stato della malattia)
    E.2.2Secondary objectives of the trial
    Assessment and treatment comparison of the following objectives between the FX06 and placebo group:
    a)Disease progression/improvement (WHO scale score)
    b)Lung function (partial oxygen pressure, fraction of inspired oxygen, Horowitz index)
    Lung function assessments will only be documented for the study if routinely done
    c)Oxygen saturation and breathing rate
    d)Systemic inflamation blood parameters
    e)Survival
    -Proportion of patients who survived until day 28
    -Proportion of patients who survived until day 60
    f)Capillary refill time
    -Proportion of patients with normal and pathological capillary refill time at baseline (as pathological: =2 s or normal: <2 s) and change to BL
    g)Duration of hospital stay
    h)Drug accountability (e.g., dose, number of administrations)
    i)Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimen
    j)Subgroup analysis: Concomitant medication and SARS-CoV-2 vaccination status
    k)Safety
    Confrontare la valutazione e il trattamento dei seguenti obiettivi tra il gruppo FX06 e il gruppo placebo in tutte le visite e i punti temporali disponibili:
    Progressione/miglioramento della malattia (in base al punteggio OMS)
    Funzione polmonare (pressione parziale dell’ossigeno, frazione dell’ossigeno inspirato, indice di Horowitz) e saranno documentate per lo studio solo se svolte di routine
    Saturazione dell’ossigeno e frequenza respiratoria
    Parametri di I ematici infiammazione sistemica
    Sopravvivenza con % di pazienti con sopravvivenza fino al giorno 28 e fino al giorno 60
    Tempo di riempimento capillare
    Durata della degenza in ospedale
    Contabilità del farmaco
    Tempo alla negatività della RT-PCR per SARS-CoV-2 nel campione del tratto respiratorio
    Analisi dei sottogruppi: medicinali concomitanti e stato della vaccinazione contro SARS-CoV-2
    Sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. SARS-CoV-2 infection confirmed by PCR test
    2. Hospitalised patients
    3. WHO score 4-6 [28]
    4. Oxygen saturation = 92% under room air
    5. Breathing frequency per minute = 20
    6. Patients = 18 years and < 75 years
    7. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient
    8. Willingness to comply to study procedures and study protocol
    9. Patients able to understand the requirements of the study and give written informed consent
    1. Infezione da SARS-CoV-2 confermata mediante test della PCR
    2. Pazienti ricoverati
    3. Punteggio OMS 4-6 [28]
    4. Saturazione dell’ossigeno =92% in aria ambiente
    5. Frequenza respiratoria =20 al minuto
    6. Pazienti di età =18 anni e <75 anni
    7. Consenso informato scritto ottenuto dal paziente prima dell’avvio di qualsiasi procedura richiesta dal protocollo
    8. Disponibilità a sottoporsi alle procedure dello studio e a seguirne il protocollo
    9. Paziente capace di comprendere i requisiti dello studio e di fornire il consenso informato scritto
    E.4Principal exclusion criteria
    1. Significant underlying known co-morbidities or conditions, defined as: o Other severe advanced or chronic lung diseases (e.g., COPD Gold = III, severe silicosis)
    o End-stage chronic kidney disease (stage 5)
    o End-stage chronic heart failure (NYHA = III)
    o Dementia
    o Baseline neurologic disease which would preclude rehabilitation potential
    o Disseminated and/or metastasised malignancy
    o Severe deconditioning with a life expectancy of less than 6 months according to the treating physician
    o Immunocompromised patients
    - recipient of a solid organ transplant
    - regular intake of anti-inflammatory therapy due to concomitant auto- immune diseases (e.g., biologics)
    - primary immune deficiency
    2. Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient's safety and with the study outcome as judged by the treating physician
    3. Women pregnant or breastfeeding
    4. Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index <1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
    5. Current participation in another interventional clinical trial with IMP or participation within the last 30 days
    1. Comorbilità o patologie soggiacenti significative, definite come:
    o Altre malattie polmonari gravi avanzate o croniche (ad es., BPCO Gold =III, silicosi grave)
    o Malattia renale cronica allo stadio terminale (stadio 5)
    o Insufficienza cardiaca cronica allo stadio terminale (NYHA =III)
    o Demenza
    o Malattie neurologiche al basale in grado di precludere la possibilità di riabilitazione
    o Malignità disseminate e/o metastatizzate
    o Decondizionamento grave con aspettativa di vita inferiore a 6 mesi secondo il medico curante
    o Pazienti immunocompromessi
    ¿ riceventi di un trapianto di organo solido
    ¿ che assumono regolarmente una terapia antinfiammatoria a causa di malattie autoimmuni concomitanti (ad es., medicinali biologici)
    ¿ con immunodeficienza primaria
    2. Evidenza di altre malattie concomitanti significative non controllate e/o di malattie non controllate con prognosi infausta che probabilmente interferirebbero con la valutazione della sicurezza del paziente e con l’esito dello studio, secondo il giudizio del medico curante
    3. Donne in stato di gravidanza o in fase di allattamento
    4. Soggetti maschi e femmine potenzialmente fertili che non intendono utilizzare un metodo di contraccezione efficace per la durata dello studio (definito come indice di PEARL <1; ad es., pillola contraccettiva, dispositivo intrauterino (IUD) o astinenza sessuale, occlusione bilaterale delle tube o partner maschile con vasectomia; per ulteriori informazioni, consultare anche la Sezione 19.2)
    5. Partecipazione in corso o nei 30 giorni precedenti a un altro studio clinico interventistico con IMP
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo until day 28.
    - Proportion of patients with worsened disease state until day 28 in both treatment groups
    L’obiettivo primario è dimostrare una differenza nella proporzione di pazienti con progressione/peggioramento dello stato della malattia tra i pazienti che ricevono FX06 e i pazienti che ricevono placebo fino al giorno 28.
    Proporzione di pazienti con peggioramento dello stato della malattia fino al giorno 28 in entrambi i gruppi di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    BL to D28
    Basale sino al Giorno 28
    E.5.2Secondary end point(s)
    Assessment and treatment comparison of the following objectives at all available visits and time points between the FX06 and placebo group:
    a) Disease progression/improvement (WHO scale score)
    - Proportion of patients with improved or progressed disease state
    - Proportion of patients with each WHO score
    - Average change in WHO score compared to BL
    - Average WHO score
    - Proportion of patients in each disease severity state (uninfected, mild, moderate, severe, dead)
    - Proportion of patients who need mechanical ventilation and number of ventilation days
    - Proportion of patients who need ECMO and number of days on ECMO
    b) Lung function (partial oxygen pressure, fraction of inspired oxygen, Horowitz index)
    - Absolute PaO2 (mmHg) values and change compared to BL
    - Absolute FiO2 (mmHg, fraction of inspired oxygen) and its change to BL
    - Horowitz Index (mmHg) and change to BL
    (Lung function assessments will only be documented for the study if routinely done)
    c) Oxygen saturation and breathing rate
    - Oxygen saturation and breathing rate and change to BL
    - Proportion of patients reaching > 92% oxygen saturation under room air
    d) Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin)
    - Concentration of blood parameters and their change to BL
    - Proportion of patients with normalized systemic inflammation (for each inflammation parameter)
    e) Survival
    - Proportion of patients who survived until day 28
    - Proportion of patients who survived until day 60
    f) Capillary refill time
    - Proportion of patients with normal and pathological capillary refill time at baseline (as pathological: =2 s or normal: <2 s) and change to BL
    g) Duration of hospital stay
    - Length of hospital stay until day 28 or until day 60
    - Proportion of patients that have been discharged from the hospital until day 28 and day 60
    - Location where patients have been discharged to (if applicable; e.g. home, rehabilitation centre)
    h) Drug accountability (e.g., dose, number of administrations)
    - Number of IMP administrations
    - Mean IMP dose per day and mean cumulative IMP dose SARS-CoV-2 rRT-PCR ct values and time to negativity (i.e. two
    consecutive negative PCR-tests as defined by each local laboratory)
    i) Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimen
    - Proportion of patients with a negative SARS-CoV-2 PCR test at day 6, 10 and 28
    - Change (reduction) in SARS-CoV-ct-values
    j) Subgroup analysis: Concomitant medication and SARS-CoV-2 vaccination status
    - Proportion of patients with a specific type of concomitant medication (e.g., antibiotics, corticosteroids, antibody therapy, etc.) and different SARS-CoV-2 vaccination status (completely vaccinated, vaccinated once, not vaccinated, last vaccination more than 6 months ago)
    - Comparison of patients with different concomitant medications and vaccination status in terms of safety events and efficacy parameters
    k) Safety
    - Safety parameters (evaluated at safety set)
    - Number of adverse events and serious adverse events
    - Type and severity (mild, moderate, severe) of (serious) adverse events
    - Seriousness and relatedness of (S)AEs
    - Mean number per patient and total number of injection related (S)AEs within 1 h after injection of IMP
    - Treatment-related (S)AEs
    Confrontare la valutazione e il trattamento dei seguenti obiettivi tra il gruppo FX06 e il gruppo placebo in tutte le visite e i punti temporali disponibili:
    • Progressione/miglioramento della malattia (in base al punteggio WHO)
    ¿ Proporzione di pazienti con miglioramento o progressione dello stato della malattia
    ¿ Proporzione di pazienti con ogni punteggio WHO
    ¿ Variazione media del punteggio WHO rispetto al basale
    ¿ Punteggio WHO medio
    ¿ Proporzione di pazienti in ogni stato di gravità della malattia (non infetto, lieve, moderato, grave, deceduto)
    ¿ Proporzione di pazienti con necessità di ventilazione meccanica e numero dei giorni di ventilazione
    ¿ Proporzione di pazienti con necessità di ECMO e numero dei giorni di ECMO

    • Funzione polmonare (pressione parziale dell’ossigeno, frazione dell’ossigeno inspirato, indice di Horowitz)
    ¿ Valori assoluti della PaO2 (mmHg) e variazione rispetto al basale
    ¿ FiO2 assoluta (mmHg, frazione dell’ossigeno inspirato) e variazione rispetto al basale
    ¿ Indice di Horowitz (mmHg) e variazione rispetto al basale
    (Le valutazioni della funzione polmonare saranno documentate per lo studio solo se svolte di routine)

    • Saturazione dell’ossigeno e frequenza respiratoria
    ¿ Saturazione dell’ossigeno, frequenza respiratoria e variazione rispetto al basale
    ¿ Proporzione di pazienti che raggiunge una saturazione dell’ossigeno >92% in aria ambiente
    • Infiammazione sistemica (variazione e normalizzazione di troponina, procalcitonina, proteina C-reattiva (CRP), conta leucocitaria, ferritina, D-dimero, lattato, lattato deidrogenasi, albumina)
    ¿ Concentrazione dei parametri ematici e variazione rispetto al basale
    ¿ Proporzione di pazienti con infiammazione sistemica normalizzata (per ciascun parametro dell’infiammazione)
    • Sopravvivenza
    ¿ Proporzione di pazienti con sopravvivenza fino al giorno 28
    ¿ Proporzione di pazienti con sopravvivenza fino al giorno 60
    • Tempo di riempimento capillare
    ¿ Proporzione di pazienti con tempo di riempimento capillare normale e patologico al basale (patologico: =2 s, oppure normale: <2 s) e variazione rispetto al basale
    • Durata della degenza in ospedale
    ¿ Durata della degenza in ospedale fino al giorno 28 o fino al giorno 60
    ¿ Proporzione di pazienti dimessi dall’ospedale fino al giorno 28 e fino al giorno 60
    ¿ Struttura presso la quale i pazienti sono stati dimessi (se applicabile; ad es., domicilio, centro di riabilitazione)

    • Contabilità del farmaco (ad es., dosi e numero di somministrazioni)
    ¿ Numero di somministrazioni del medicinale sperimentale (investigational medicinal product, IMP)
    ¿ Dose media dell’IMP per giorno e dose cumulata media dell’IMP

    • Valori ct per SARS-CoV-2 alla rRT-PCR e tempo alla negatività (ossia due test della PCR negativi consecutivi, definiti da ciascun laboratorio locale)
    ¿ Tempo alla negatività della RT-PCR per SARS-CoV-2 nel campione del tratto respiratorio
    ¿ Proporzione di pazienti con un test della PCR negativo per SARS-CoV-2 ai giorni 6, 10 e 28
    ¿ Variazione (riduzione) dei valori ct per SARS-CoV

    • Analisi dei sottogruppi: medicinali concomitanti e stato della vaccinazione contro SARS-CoV-2
    ¿ Proporzione di pazienti con uno specifico tipo di medicinali concomitanti (ad es., antibiotici, corticosteroidi, terapia anticorpale ecc.) e vari stati della vaccinazione contro SARS- CoV-2 (completamente vaccinato, vaccinato con una dose, non vaccinato, ultima vaccinazione risalente a oltre 6 mesi prima)
    ¿ Confronto tra i pazienti con diversi medicinali concomitanti e stato della vaccinazione in termini di eventi relativi alla sicurezza e parametri di efficacia
    Sicurezza
    • Parametri di sicurezza (valutati nel set di sicurezza)
    ¿ Numero di eventi avversi ed eventi avversi (AE) gravi
    ¿ Tipologia e gravità (lieve, moderato, grave) degli eventi
    E.5.2.1Timepoint(s) of evaluation of this end point
    BL to at all available visits and time points
    Dal tempo Basale alle visite disponibili secondo il Protocollo dello studio
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    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
    Data base hard lock
    In order to fulfil sponsor obligations (ICH E6[R2]) by monitoring and source data verification at site to confirm data integrity and patient safety the definition LVLS/LPLV cannot be used as end of trial. The access to hospitals and isolated departments as ICUs are hindered to avoid spreading of SARS-CoV-2 infections. Therefore, site monitoring visits and site data corrections within eCRF may only be performed significantly after LVLS/LPLV.
    Chiusura del Data Base
    La verifica dei dati della fonte in loco per confermare l'integrità dei dati e la sicurezza del paziente, la definizione LVLS/LPLV non può essere utilizzata come fine della sperimentazione. L'accesso agli ospedali e ai reparti isolati come terapia intensiva è ostacolato per evitare la diffusione delle infezioni da SARS-CoV-2: il monitoraggio al centro e le correzioni dei dati del centro all'interno di eCRF possono essere eseguite solo in modo significativo dopo LVLS/LPLV.
    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 months9
    E.8.9.1In the Member State concerned days63
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days63
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 306
    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 (Standard of Care)
    Nessuno (Standard di Cura)
    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 Decision2022-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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