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    Summary
    EudraCT Number:2020-001972-13
    Sponsor's Protocol Code Number:COVID-19HD
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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 number2020-001972-13
    A.3Full title of the trial
    Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD)
    Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina a basso peso molecolare in pazienti ricoverati per grave polmonite in corso di COVID-19 e coagulopatia, e che non richiedano ventilazione meccanica invasiva. (COVID-19 HD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD)
    Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina a basso peso molecolare in pazienti ricoverati per grave polmonite in corso di COVID-19 e coagulopatia, e che non richiedano ventilazione meccanica invasiva. (COVID-19 HD)
    A.3.2Name or abbreviated title of the trial where available
    Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight he
    Studio randomizzato controllato sull’efficacia e sulla sicurezza di alte verso basse dosi di eparina
    A.4.1Sponsor's protocol code numberCOVID-19HD
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA
    B.1.3.4CountryItaly
    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 supportFondo Ricerca -Emergenza COVID-19
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Modena
    B.5.2Functional name of contact pointClinical Trial Quality Team
    B.5.3 Address:
    B.5.3.1Street Addressvia Del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailmighali.pasquale@aou.mo.it
    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 Inhixa
    D.2.1.1.2Name of the Marketing Authorisation holderTechdow Europe AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameInhixa
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNenoxaparina sodica
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4000 to 8000
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.
    Pazienti ricoverati in ospedale con grave polmonite da COVID-19 e coagulopatia, che non necessitano di ventilazione meccanica invasiva
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.
    Pazienti ricoverati in ospedale con grave polmonite da COVID-19 e coagulopatia, che non necessitano di ventilazione meccanica invasiva
    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 10053983
    E.1.2Term Corona virus 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
    To assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:
    a) more effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:
    1. Death
    2. Acute Myocardial Infarction [AMI]
    3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
    4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation
    5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation
    b) Similar in terms of major bleeding risk during hospital stay
    Valutare se alte dosi di eparina a basso peso molecolare (EBPM) (ie. Enoxaparina 70 IU/kg ogni 12 ore), confrontate con le dosi standard utilizzate per la profilassi del trombembolismo venoso (ie, Enoxaparina 4000 IU una volta al dì) sono:
    a) più efficaci nel prevenire il peggioramento clinico, definito come la comparsa, durante il ricovero ospedaliero, del primo fra questi eventi:
    1. Morte
    2. Infarto miocardico acuto (IMA)
    3. Trombombolismo venoso o arterioso sintomatico, confermato da indagini strumentali
    4. Necessità di ricorrere a ventilazione meccanica non invasiva - intesa come Continuous Positive Airway Pressure (Cpap), Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
    5. Necessità di ricorrere a ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva
    b) Simili in termini di emorragia maggiore
    E.2.2Secondary objectives of the trial
    To assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) differ in terms of the following events occurring during hospital stay:
    a) Laboratory parameters of disease severity, including:
    1. D-dimer level
    2. Plasma fibrinogen levels
    3. Mean Platelet Volume
    4. Lymphocyte/Neutrophil ratio
    5. IL-6 plasma levels
    b) Clinically relevant non-major bleeding
    c) Death during hospital stay and at 30 days
    d) Acute Myocardial Infarction [AMI]
    e) Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
    f) Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
    g) Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
    Valutare se alte dosi di eparina a basso peso molecolare(EBPM)(ie. Enoxaparina 70 IU/kg ogni 12 ore),confrontate con le dosi standard utilizzate per la profilassi del trombembolismo venoso(ie,Enoxaparina 4000 IU una volta al dì)differiscono in termini di incidenza durante ricovero ospedaliero dei seguenti eventi:
    a) Variazioni dei parametri di lab.indicatori della gravità di malattia,quali:
    1. Livelli plasmatici di D-dimero
    2. Livelli plasmatici di fibrinogeno
    3. Volume Medio Piastrinico
    4. Rapporto Linfociti/neutrofili
    5. Livelli plasmatici di IL-6
    b) Emorragia non maggiore,clinicamente rilevante
    c) Morte intraospedaliera e a 30 g
    d) Infarto Miocardico Acuto
    e)Tromboembolismo venoso o arterioso sintomatico
    f) Necessità di ricorrere a ventilazione meccanica non invasiva o invasiva per i pz. che alla randomizzazione sono in ossigeno terapia standard
    g) Necessità di ricorrere a ventilazione meccanica invasiva per i pz. che alla randomizzazione sono in ventilazione meccanica non invasiva
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients admitted to the hospital with COVID-19 confirmed by PCR test on throat swab samples, and with severe pneumonia plus coagulopathy, defined as the presence of at least one clinical and one laboratory criteria.
    Clinical criteria (at least one)
    1) Respiratory Rate = 25 breaths /min
    2) Arterial oxygen saturation = 93% at rest in room air
    3) PaO2/FiO2 = 300 mmHg
    Laboratory criteria and SIC score (at least one )
    1) D-dimer > 4 times the upper level of normal reference range
    2) Sepsis-Induced Coagulopathy (SIC) score > 4
    Pazienti ricoverati in ospedale con COVID-19 confermato da PCR su tampone naso-faringeo, con polmonite grave e coagulopatia, definite come la presenza di almeno un criterio clinico ed uno di laboratorio, che non necessitano di ventilazione meccanica invasiva
    Criteri Clinici (almeno uno)
    1) Frequenza Respiratoria =25 atti/min
    2) Saturazione arteriosa di ossigeno =93% a riposo in aria ambiente
    3) PaO2/FiO2 =300 mmHg
    Criteri dl laboratorio e SIC score (almeno uno)
    1) D-dimero >4 volte il limite superiore di riferimento del laboratorio
    2) Sepsis-Induced Coagulopathy (SIC) score >4
    E.4Principal exclusion criteria
    1. Age < 18 and > 80 years
    2. Invasive ventilation
    3. Thrombocytopenia (platelet count < 80.000 mm3)
    4. Coagulopathy: INR >1.5, aPTT ratio >1.4
    5. Impaired renal function (eGFR by CKD-EPI Creatinine equation < 30 ml/min)
    6. Known hypersensitivity to enoxaparin
    7. History of heparin induced thrombocytopenia
    8. Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at high risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
    9. Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves)
    10. Concomitant double antiplatelet therapy
    11. Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed
    12. Pregnancy or breastfeeding or positive pregnancy test
    13. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition)
    14. Lack or withdrawal of informed consent
    1. Eta <18 e > 80 anni
    2. Ventilazione meccanica invasiva
    3. Piastrinopenia (conta piastrinica < 80.000 mm3)
    4. Coagulopatia: INR >1.5, aPTT ratio >1.4
    5. Insufficienza renale (eGFR secondo l’equazione CKD-EPI Creatinina <30 ml/min)
    6. Allergia nota ad Enoxaparina
    7. Storia di piastrinopenia da eparina
    8. Presenza di sanguinamento attivo, o di una condizione ad alto rischio di sanguinamento in presenza di terapie anticoagulanti (ad esempio: recente ictus emorragico, ulcera peptica, neoplasie maligne ad alto rischio emorragico, recente intervento di neurochirurgia o chirurgia endooculare, aneurismi vascolari, malformazioni arterovenose)
    9. Terapie anticoagulanti in atto per altre indicazioni (ad es: fibrillazione atriale, tromboembolismo venoso, protesi valvolari cardiache meccaniche)
    10. Concomitante doppia terapia antiaggregante
    11. Somministrazione di dosi terapeutiche di eparina non frazionata, EBPM o fondaparinux per più di 72 ore precedenti la randomizzazione. Sono concesse dosi profilattiche degli stessi farmaci
    12. Gravidanza o allattamento
    13. Presenza di patologie gravi che determinano aspettativa di vita < 28 giorni
    14. Rifiuto a firmare il consenso informato, o revoca dello stesso.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:
    • Death
    • Acute Myocardial Infarction [AMI]
    • Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
    • Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
    • Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation

    Primary safety endpoint:
    Major bleeding, defined as an acute clinically overt bleeding associated with one or more of the following:
    • Decrease in hemoglobin of 2 g/dl or more;
    • Transfusion of 2 or more units of packed red blood cells;
    • Bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal];
    • Bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death);
    • Bleeding that necessitates surgical intervention
    Endpoint primario di Efficacia
    Peggioramento clinico, definito come la comparsa, durante il ricovero ospedaliero, del primo fra questi eventi:
    1. Morte
    2. Infarto miocardico acuto (IMA)
    3. Trombombolismo venoso o arterioso sintomatico,obiettivamente confermato
    4. Ventilazione Meccanica non invasiva -intesa come Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
    5. Ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva

    Endpoint primario di sicurezza:
    Sanguinamento maggiore, definito come sanguinamento clinicamente evidente acuto associato a uno o più dei seguenti:
    • Diminuzione dell'emoglobina pari o superiore a 2 g / dl;
    • Trasfusione di 2 o più unità di packed red blood cells;
    • Sanguinamento che si verifica in almeno uno dei seguenti siti critici (intracranico, intraspinale, intraoculare (all'interno del corpo dell'occhio; pertanto, un sanguinamento congiuntivale non è un sanguinamento intraoculare), pericardico, intra-articolare, intramuscolare con sindrome compartimentale, o retroperitoneale];
    • Sanguinamento che è fatale (definito come un evento sanguinante che è stata la principale causa di morte o ha contribuito direttamente alla morte);
    • Sanguinamento che richiede un intervento chirurgico
    E.5.1.1Timepoint(s) of evaluation of this end point
    occurrence of at least one of the events during hospitalization time
    verificarsi di almeno uno degli eventi durante il tempo di ospitalizzazione.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    Any of the following events:
    - Death
    - Acute Myocardial Infarction [AMI]
    - Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
    - Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
    - Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
    - Improvement of laboratory parameters of disease severity, including:
    o D-dimer level
    o Plasma fibrinogen levels
    o Mean Platelet Volume
    o Lymphocyte/Neutrophil ratio
    o IL-6 plasma levels

    Secondary safety endpoint:
    Clinically Relevant non-major bleeding, defined as an acute clinically overt bleeding that does not meet the criteria for major and consists of:
    • Any bleeding compromising hemodynamics;
    • Spontaneous hematoma larger than 25 cm2, or 100 cm2 if there was a traumatic cause;
    • Intramuscular hematoma documented by ultrasonography;
    • Epistaxis or gingival bleeding requiring tamponade or other medical intervention;
    • Bleeding from venipuncture for >5 minutes;
    • Hematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures;
    • Hemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention;
    • or any other bleeding requiring temporary cessation of a study drug.
    Endpoint secondari di efficacia:
    Uno dei seguenti eventi:
    - Morte
    - Infarto miocardico acuto (IMA)
    - Trombombolismo venoso o arterioso sintomatico,obiettivamente confermato
    - Ventilazione Meccanica non invasiva -intesa come Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - o invasiva per i pazienti che alla randomizzazione sono in ossigeno terapia standard
    - Ventilazione meccanica invasiva per i pazienti che alla randomizzazione sono in ventilazione meccanica non invasiva
    - Miglioramento dei parametri di laboratorio della gravità della malattia, tra cui:
    o livello D-dimero
    o Livelli di fibrinogeno plasmatico
    o Volume piastrinico medio
    o Rapporto linfociti / neutrofili
    o livello di IL-6
    o mortalità a 30 giorni

    Endpoint secondario di sicurezza :
    Sanguinamento clinicamente rilevante non maggiore, definito come sanguinamento clinicamente evidente acuto che non soddisfa i criteri principali e consiste in:
    • Qualsiasi sanguinamento che compromette l'emodinamica;
    • Ematoma spontaneo maggiore di 25 cm2 o 100 cm2 se ciò è stato una causa traumatica;
    • Ematoma intramuscolare documentato mediante ecografia;
    • Epistassi o sanguinamento gengivale che richiedono tamponamento o altri interventi medici;
    • Sanguinamento dalla venipuntura per> 5 minuti;
    • Ematuria macroscopica, spontanea o durata per più di 24 ore dopo procedure invasive;
    • Emottisi, ematemesi o sanguinamento rettale spontaneo che richiede endoscopia o altri interventi medici;
    • o qualsiasi altro sanguinamento che richiede l'interruzione temporanea di un farmaco in studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    these outcomes will be collected during the hospitalization period and for the death event even 30 days after randomization. They will be analyzed both as binary outcomes and as survival data
    questi esiti saranno raccolti durante il periodo di ospedalizzazione e per l'evento morte anche a 30 giorni dalla randomizzazione. Saranno analizzati sia come outcome binari sia come dati di sopravvivenza
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    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 concerned11
    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 Information not present in EudraCT
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    best therapy available at the moment
    miglior terapia disponibile al momento
    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 Decision2020-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
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