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    Summary
    EudraCT Number:2020-001795-15
    Sponsor's Protocol Code Number:COMBAT-19
    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 number2020-001795-15
    A.3Full title of the trial
    A randomized, double blind, placebo-COntrolled trial of MavrilimumaB for Acute respiratory failure due To COVID-19 pneumonia with hyperinflammation: the COMBAT-19 trial
    Studio in doppio cieco randomizzato controllato con placebo con mavrilimumab per trattare l’insufficienza respiratoria acuta nella polmonite COVID-19 con iperinfiammazione: lo studio COMBAT-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study aimed to verify the efficacy and safety of mavrilimumab in COVID-19-associated pneumonia in patients who have signs of excessive inflammation
    Studio clinico per verificare efficacia e sicurezza di mavrilimumab nella cura della polmonite associata a COVID-19 nei pazienti che mostrano segni di eccessiva infiammazione
    A.3.2Name or abbreviated title of the trial where available
    Mavrilimumab in COVID-19 pneumonia with hyperinflammation
    Mavrilimumab per la polmonite COVID-19 con iperinfiammazione
    A.4.1Sponsor's protocol code numberCOMBAT-19
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportKiniksa Pharmaceuticals
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointSegreteria UnIRAR
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226434683
    B.5.5Fax number0226432230
    B.5.6E-maildirezione.unirar@hsr.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 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 namemavrilimumab
    D.3.2Product code [KPL-301]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmavrilimumab
    D.3.9.2Current sponsor codeKPL-301
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory failure during COVID-19 pneumonia and hyperinflammation
    Insufficienza respiratoria in corso di polmonite COVID-19 ed iperinfiammazione
    E.1.1.1Medical condition in easily understood language
    Difficulty in breathing that requires oxygen supplementation caused by the COVID-19 infection with associated uncontrolled inflammation
    Difficoltà nel respiro che necessita di ossigeno causata dal infezione COVID-19 con associato uno stato di infiammazione non controllata
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the benefit of mavrilimumab vs placebo added to best standard of care in reducing the dependency on oxygen supplementation in patients with COVID-19 pneumonia and signs of systemic hyperinflammation
    Dimostrare il beneficio di mavrilimumab rispetto al placebo aggiunto al migliore standard di cura nel ridurre la dipendenza dalla supplementazione di ossigeno nei pazienti con polmonite COVID-19 e segni di iperinfiammazione sistemica
    E.2.2Secondary objectives of the trial
    To evaluate clinical outcomes using the WHO 7-point ordinal scale
    To evaluate the time to disappearance of fever if present at baseline
    To demonstrate the potential benefit of mavrilimumab in reducing the case fatality rate over 4 weeks in the study cohort regardless of other subsequent clinical interventions
    To evaluate the in-hospital outcomes in the study cohort
    To evaluate change in laboratory parameters through follow up
    To evaluate changes in the National Early Warning Score 2 (NEWS2)
    To evaluate the variations in radiological findings in patients that underwent a repeated radiological evaluation (mavrilimumab vs placebo)
    To evaluate safety of mavrilimumab in the study cohort
    To evaluate the clinical efficacy of mavrilimumab compared to the control arm by clinical severity (i.e. mild vs moderate subgroup)
    To measure the time course of the effects of mavrilimumab on biomarkers
    Valutare gli outcomes clinici utilizzando la WHO 7-point ordinal scale
    Valutare il tempo alla scomparsa della febbre se presente al basale
    Dimostrare il potenziale beneficio di mavrilimumab nel ridurre la mortalità a 4 settimane nella coorte di studio, indipendentemente da altri interventi clinici successivi
    Valutare gli outcomes in ospedale nella coorte di studio
    Valutare la modifica dei parametri di laboratorio durante il follow-up
    Valutare le modifiche al National Early Warning Score 2 (NEWS2)
    Valutare le variazioni dei reperti radiologici nei pazienti sottoposti a ripetuta valutazione radiologica (mavrilimumab vs placebo)
    Valutare la sicurezza di mavrilimumab nella coorte di studio
    Valutare l'efficacia clinica di mavrilimumab rispetto al braccio di controllo in base alla gravità clinica (ovvero sottogruppo lieve o moderato)
    Misurare l'effetto di mavrilimumab sui biomarcatori di infiammazione e virali
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults (= 18 years old)
    2. Signed informed consent
    3. Patients clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology
    4. Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with pulmonary infiltrates
    5. Patient requiring oxygen supplementation (i.e. with a SpO2 = 94% while breathing room air) and having a PAO2/FIO2 ratio = 300 mmHg
    6. Lactate dehydrogenase (LDH) > normal range and at least one of the following:
    - fever > 38.0 °C;
    - increased levels of C-reactive Protein (CRP) = 10x UNL mg/L (= 60 mg/lL);
    - increased levels of ferritin = 2.5x UNL ( = 1000 ¿gmg/L)
    1. Soggetti adulti (= 18 anni)
    2. Sottoscrizione di un consenso informato
    3. Pazienti con diagnosi clinica di virus SARS-CoV-2 mediante PCR o altra metodologia diagnostica approvata
    4. Ricoverato in ospedale con evidenza polmonite da COVID-19 evidenziata dalla radiografia del torace o dalla TAC torace
    5. Pazienti con necessità di supplementazione di ossigeno (ovvero con una SpO2 = 94% in aria ambiente) e un rapporto PaO2/FIO2 = 300 mmHg
    6. Lattato deidrogenasi (LDH)> intervallo normale e almeno uno dei seguenti:
        - febbre> 38,0 ° C;
        - aumento dei livelli di proteina C-reattiva (PCR) = 10x valori di norma mg / L (= 60 mg / lL);
        - aumento dei livelli di ferritina = 2,5x valori di norma (= 1000 ug/L)
    E.4Principal exclusion criteria
    1. Onset of COVID-19 pneumonia symptoms (i.e. dyspnea/respiratory insufficiency) >14 days
    2. On mechanical ventilation at the time of randomization
    3. A PaO2/FiO2 < 100 mmHg
    4. Uncontrolled systemic infection (other than COVID-19)
    5. Hypersensitivity to the active substance or to any of the excipients of the experimental drug
    6. Total neutrophil count < 1500/mm3
    7. Severe hepatic cirrhosis
    8. History of chronic HBV or HCV infection
    9. Known or active tuberculosis (TB) or a history of incompletely treated TB; suspected or known extrapulmonary tuberculosis
    10. Moderate/severe heart failure (NYHA Class 3 or 4)
    11. Any prior (within the defined periods below) or concurrent use of immunosuppressive therapies including but not limited to the following:
    a. Anti-IL-6, anti-IL-6R antagonists or Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period;
    b. Cell-depleting agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level;
    c. Anakinra within 1 week of baseline; canakinumab within 8 weeks of baseline; abatacept within 8 weeks of baseline.
    d. Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer;
    e. Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline;
    f. Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide or methotrexate within 4 weeks of baseline.
    12. Pregnancy or lactation (Note: Women of childbearing age should use effective contraception/abstinence after treatment with mavrilimumab and for 3 months after the dosing)
    13. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
    14. In the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours, irrespective of the provision of treatments
    15. Current participation in any other interventional investigational trials
    1. Insorgenza dei sintomi della polmonite COVID-19 (es. Dispnea / insufficienza respiratoria) da oltre 14 giorni
    2. Sottoposti a ventilazione meccanica al momento della randomizzazione
    3. Presenza di un rapporto PaO2 / FiO2 <100 mmHg
    4. Infezione sistemica non controllata (diversa da COVID-19)
    5. Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti del farmaco sperimentale
    6. Conta totale dei neutrofili <1500 / mm3
    7. Grave cirrosi epatica
    8. Storia di infezione cronica non guarita da HCV o HBV
    9. Tubercolosi attiva o storia di tubercolosi non trattata in modo
    adeguato; tubercolosi extrapolmonare nota o sospettata
    10. Scompenso cardiaco congestizio (classe NYHA 3 o 4)
    11. Qualsiasi uso precedente (entro i periodi definiti di seguito) o concomitante di terapie immunosoppressive, incluso ma non limitato a quanto segue:
       a. Anticorpi anti-IL-6, anti-IL-6R o inibitori della Janus chinasi (JAKi) negli ultimi 30 giorni o previsione di trattamento durante il periodo di studio;
       b. Agenti di deplezione cellulare (ad es. Anti CD20) senza evidenza di recupero delle cellule B al livello basale alla randomizzazionee;
       c. Anakinra entro 1 settimana dalla linea di base; canakinumab entro 8 settimane dalla linea di base; abatacept entro 8 settimane dal basale.
       d. Inibitori del fattore di necrosi tumorale (TNF) entro 2-8 settimane (etanercept entro 2 settimane, infliximab, certolizumab, golimumab o adalimumab entro 8 settimane) o dopo che sono trascorse almeno 5 emivite, a seconda di quale sia il periodo più lungo;
       e. Agenti alchilanti inclusa ciclofosfamide (CYC) entro 6 mesi dalla randomizzazione;
       f. Ciclosporina (CsA), azatioprina (AZA) o micofenolato mofetile (MMF) o leflunomide o metotrexato entro 4 settimane dalla randomizzazione.
    12. Gravidanza o allattamento (Nota: le donne in età fertile devono usare un metodo contraccettivo / astinenza efficace dopo il trattamento con mavrilimumab e per 3 mesi dopo la somministrazione)
    13. Qualsiasi grave condizione medica o anomalia dei test clinici di laboratorio che, a giudizio dello sperimentatore, precluda la partecipazione sicura del paziente e il completamento dello studio
    14. Secondo il parere dello sperimentatore, progressione verso la morte imminente o molto probabile entro le 24 ore dalla randomizzazione, indipendentemente dall'inizio di possibili trattamenti
    15. Partecipazione attuale a qualsiasi altro studio sperimentale interventistico
    E.5 End points
    E.5.1Primary end point(s)
    Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan-Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm.
    Tempo al raggiungimento dell'autonomia respiratoria nei primi 14 giorni dal trattamento (tempo al primo periodo di 24 ore con una SpO2 del 94%), valutato come stima Kaplan-Mayer della percentuale di pazienti in aria ambiente al giorno 14 e tempo mediano al raggiungimento dell'aria ambiente in ciascun braccio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily evaluation until day 14
    Valutazione quotidiana sino al giorno 14
    E.5.2Secondary end point(s)
    Variations from baseline to subsequent CT scans (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern, parenchymal consolidations, and evolution towards fibrosis.; Number of patients with treatment-related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs; To evaluate the primary and secondary endpoints in different subgroups of patients:
    - mild respiratory failure: PaO2/FiO2 = 300 and > 200 mmHg;
    - moderate respiratory failure: PaO2/FiO2 = 200 and > 100 mmHg; Median changes in exploratory biomarkers:
    - Inflammatory biomarkers (i.e. IL-6, IL-1RA, TNF-alpha, CBC and differential)
    - Levels of antibodies to SARS-CoV-2
    - Levels of anti-drug antibiodies (ADA); Proportion of patients not requiring oxygen supplementation (i.e., response rate. Response is defined as a 7- point ordinal scale of 3 or less based on the WHO 7-point ordinal scale).; Proportion of patients with at least 2 levels improvement in clinical status as evaluated the WHO 7-point ordinal scale; Median time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner in the 4-week period after study treatment.; COVID-19-related death during the 4-week period after study treatment (in hospital and overall); Proportion of hospitalized patients who died or required mechanical ventilations (WHO Categories 1 or 2) by day 14; Median variations of the following serological markers over follow-up:
    - C-reactive protein
    - Ferritin
    - D-Dimer; Median change in NEWS2 score from baseline; Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first)
    Variazioni dal basale ai studi successivi radiologici (se disponibili) in termini di percentuale di coinvolgimento polmonare, modifiche del parenchima normale, opacità a vetro smerigliato, crazy paving, consolidamenti parenchimali ed evoluzione verso la fibrosi.; Numero di pazienti con effetti collaterali correlati al trattamento (secondo i criteri di terminologia comune per eventi avversi (CTCAE) v.5.0), eventi avversi gravi, eventi avversi di interesse particolare, cambiamenti clinicamente significativi nelle misurazioni di esami di laboratorio e segni vitali; Valutare gli endpoint primari e secondari in diversi sottogruppi di pazienti:
    - insufficienza respiratoria lieve: PaO2 / FiO2 = 300 e> 200 mmHg;
    - insufficienza respiratoria moderata: PaO2 / FiO2 = 200 e> 100 mmHg; Cambiamenti nei valori mediani dei biomarcatori esplorativi:
    - Biomarcatori infiammatori (es. IL-6, IL-1RA, TNF-alfa, emocromo + formula)
    - Livelli di anticorpi contro SARS-CoV-2
    - Livelli di anticorpi anti-farmaco (ADA); Proporzione di pazienti in autonomia respiratoria (tasso di risposta, ovvero incremento ad un punteggio di 3 o superiore secondo la scala ordinale dell'OMS a 7 punti); Proporzione di pazienti con incremento di almeno due livelli dello stato clinico secondo la scala ordinale dell'OMS a 7 punti; Tempo mediano trascorso sino alla risoluzione della febbre (per almeno 48 ore) in assenza di antipiretici o dimissione, a seconda di quale delle due settimane si verifica prima del periodo di studio.; Numero di decessi correlato a COVID-19 durante il periodo di 4 settimane dopo il trattamento in studio (in ospedale e globale); Proporzione di pazienti deceduta o che ha necessitato di ventilazione meccanica (punteggio WHO 6 o 7) al giorno 14; Variazioni delle mediane dei seguenti marcatori sierologici durante il follow-up:
    - Proteina C-reattiva
    - Ferritina
    - D-Dimer; Mediana delle modificazioni nello score NEWS2 dalla randomizzazione; Tempi mediani al miglioramento (inteso come uno score NEWS2 inferiore o uguale a 2 o dimissione -nel caso avvenisse prima)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to any image studies conducted during the following 4 weeks and required for clinical reasons; Entire study duration; Daily during hospitalization, on days 14, 28; At randomization, discharge and on day 84 if available; Day 7, 14, 28; Day 7, 14, 28; Daily until discharge; Daily during hospitalization, then on day 14 and 28, and 84; Day 14; On alternate days during hospitalization, then on days 14 and 28 and 84; At day 3, 5, 7, 9, 11, 14, 28; Daily until discharge
    Dal basale a eventuali studi per immagine condotti durante le successive 4 settimane e richiesti per motivazioni cliniche; Tutta la durata dello studio; Quotidianamente durante il ricovero, al giorno 14, 28; Alla randomizzazione, alla dimissione e al giorno 84 se disponibile; Giorno 7, 14, 28; Giorno 7, 14, 28; Quotidiano sino alla dimissione; Quotidianamente durante il ricovero, quindi al giorno 14, 28, 84; Giorno 14; A giorni alterni durante il ricovero, quindi al giorni 14 e 28, 84; Al giorno 3, 5, 7, 9, 11, 14, 28; Quotidianamente sino alla dimissione
    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 No
    E.6.5Efficacy No
    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 No
    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 concerned3
    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 years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the patient is not capable of giving consent, consent should be given by his or her legal/authorized representative, and according to Italian laws and Regulations
    Se il paziente non fosse in grado di fornire il consenso, il consenso sarà richiesto al suo rappresentante legale / autorizzato, secondo le leggi e i regolamenti vigenti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    The condition being treated is acute condition. The study plans to follow patients up to 3 months after treatment.
    La condizione trattata è acuta. Lo studio prevede di seguire i pazienti fino a 3 mesi dal trattamento.
    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 Decision2020-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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