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    Summary
    EudraCT Number:2021-004188-28
    Sponsor's Protocol Code Number:Monet
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-13
    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 number2021-004188-28
    A.3Full title of the trial
    Adaptative, Phase IV Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults.
    Studio di fase IV randomizzato, in aperto, multicentrico per determinare la sicurezza e l'efficacia di
    diversi anticorpi monoclonali (MoAbs) contro la SARSCoV-2 per il trattamento precoce del COVID-19 in
    pazienti adulti non ospedalizzati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IV Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in Non-hospitalized Adults
    Studio di fase 4, a braccio aperto, randomizzato di pazienti con un test per SARS-Cov-2 positivo documentato e sintomi lievi di COVID19, non ospedalizzati e reclutati in Italia. Questo studio valuta l’efficacia di anticorpi monoclonali multipli paragonati alla Standard of care (SOC) per il trattamento del Covid-19 in pazienti adulti non ospedalizzati
    A.3.2Name or abbreviated title of the trial where available
    Monet
    Monet
    A.4.1Sponsor's protocol code numberMonet
    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 SponsorISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    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 supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointImmunodeficienze virali
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170546
    B.5.5Fax number0655170477
    B.5.6E-mailimmunodeficienzevirali@inmi.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 nameImdevimab
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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) Yes
    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.IMP: 2
    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 nameSotrovimab
    D.3.2Product code [-]
    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.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameSotrovimab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Yes
    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.IMP: 3
    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 nameCasirivimab
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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) Yes
    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
    COVID-19 infection
    Infezione da COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infezione da COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of MoAbs in term reduction of occurrence of death, hospitalization and severe COVD-19 by day 29 after randomization
    valutare l’efficacia di MoAbs in termini di riduzione della mortalità, ospedalizzazione e COVID-19 grave dal giorno 29 dopo la randomizzazione
    E.2.2Secondary objectives of the trial
    - To assess the effect of MoAbs in the prevention of hospitalization for COVID-19 by day 90 after
    - To assess the effect of MoAbs to reduce SARS-CoV-2 detection or levels of RNA in nasal swabs
    - To assess the effect of MoAbs on symptom resolution
    - To evaluate differences in symptom duration between the MoAbs and SoC through day 29
    - To evaluate differences in long-term symptoms and duration between the MoAbs and SoC after viral clearance
    - To investigate the humoral response to non-Spike SARS-CoV-2 antigens
    - To investigate the T-cell response to S and N viral antigens in a subgroup of enrolled patients
    - To explore if baseline and follow-up hematology, chemistry, coagulation, viral, and inflammatory biomarkers are associated with clinical and virologic outcomes in relation to any MoAbs in the study protocol
    - Viral genotypic analysis over time and phenotypic characterization of treatment-emergent mutations.
    - Valutare l’effetto di MoAbs nella prevenzione dell’ospedalizzazione per COVID-19 dal giorno 90 in poi;
    - Valutare l’effetto di MoAbs per ridurre la rilevazione di SARS-Cov-2 o i livelli di RNA nei tamponi nasali;
    - Valutare l’effetto di MoAbs sulla risoluzione dei sintomi
    - To evaluate differences in symptom duration between the MoAbs and SoC through day 29
    - To evaluate differences in long-term symptoms and duration between the MoAbs and SoC after viral clearance
    - To investigate the humoral response to non-Spike SARS-CoV-2 antigens
    - To investigate the T-cell response to S and N viral antigens in a subgroup of enrolled patients
    - To explore if baseline and follow-up hematology, chemistry, coagulation, viral, and inflammatory biomarkers are associated with clinical and virologic outcomes in relation to any MoAbs in the study protocol
    - Viral genotypic analysis over time and phenotypic characterization of treatment-emergent mutations.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacological and immunological
    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Farmacologico e immunologico
    E.3Principal inclusion criteria
    - Age = 18 years;
    - Signed informed consent provided by the patient, or by the patient’s legally authorized representative(s), as applicable;
    - Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by RT-PCR test); patients must have sample taken for test confirming viral infection no more than 3 days prior to randomization;
    - Having one or more mild or moderate COVID-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion for no more than 7 days;
    - Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method (s) of contraception (Appendix C);
    o Highly effective contraceptive measures in women include: stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening, Intrauterine device (IUD), Intrauterine hormone-releasing system (IUS), Bilateral tubal ligation, Vasectomized partner and/or Sexual abstinence.
    o Highly effective contraceptive measures in men include: study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence.
    - Eta = di 18 anni
    - Consenso informato firmato fornito dal paziente, o da rappresentanti legalmente autorizzati dal paziente;
    - Diagnosi virologica dell’infezione di SARS-CoV-2 (l’infezione da SARS-CoV-2 confermata da un test di RT-PCR); i pazienti devono essere analizzati per il test di conferma dell’infezione virale non più di 3 giorni prima rispetto alla randomizzazione;
    - Avere uno o più sintomi lievi o moderati di COVID-19: febbre, tosse, malessere, mal di testa, dolore muscolare, sintomi gastrointestinali, gola infiammata, dispnea dopo sforzo per non più di 7 giorni;
    - Uomini e donne potenzialmente fertili che hanno intrapreso una relazione eterosessuale devono rispettare l’uso di un protocollo specifico per quanto riguarda il metodo di contraccezione (Appendice C);
    - Le misure di contraccezione altamente efficaci nelle donne includono: l’assunzione stabile di contraccettivi ormonali combinati (contenenti estrogeni e progesterone) (orale, intravaginale, transdermale) o contraccettivi ormonali solo a base di progesterone (orale, iniettabile, impiantabile) associato ad una inibizione dell’ovulazione iniziata 2 o più cicli mestruali prima dello screening, dispositivo intrauterino (IUD), un Sistema di rilascio dell’ormone intrauterino (IUS), il legamento delle tube bilaterale, un partner vasectomizzato e/o astinenza sessuale.
    - Le misure di contraccezione altamente efficaci negli uomini prevedono che: i partecipanti allo studio con partner WOCBP sono obbligati all’uso di preservativi a meno che essi siano stati vasectomizzati o siano in astinenza sessuale
    E.4Principal exclusion criteria
    - Having one of the following conditions:
    o Body mass index (BMI) >30
    o Chronic kidney disease
    o Uncontrolled diabetes
    o Having immunosuppressive disease or receiving immunosuppressive treatment
    - Being >65 years old and having one of the above mentioned conditions
    - Being >55 years old and having one of the following conditions:
    o Cardiovascular or cerebrovascular disease (including hypertension with concomitant organ damage)
    o Chronic obstructive pulmonary disease (COPD) or other chronic respiratory diseases
    - Pregnancy/lactation;
    - Have oxygen saturation (SpO2) less than or equal to (=)93 percent (%) on room air and persisting for more than 7 days;
    - Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by PCR test) more than 3 days before;
    - Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
    - Enrolment in another concurrent clinical interventional study within 30 days;
    - Existence of any life-threatening co-morbidity or any other medical condition, which, in the opinion of the investigator, makes the patient unsuitable for the study;
    - Having known allergy or hypersensitivity to components of study drugs
    - Presentano una delle seguenti condizioni:
    o Indice di massa corporea (BMI) >30
    o Patologie croniche renali
    o Diabete non trattato
    o Patologie immunosuppressive o aver ricevuto trattamenti immunosoppressori
    - Avere un età >65 e avere una delle seguenti condizioni menzionate in precedenza
    - Avere un età >55 e avere una delle seguenti condizioni:
    o Patologie cardiovascolari o cerebrovascolari (incluse l’ipertensione con danno d’organo concomitante)
    o Patologie polmonari corniche ostruttive (COPD) o malattie respiratorie croniche di altro tipo

    - Gravidanza/allattamento

    - Avere una saturazione dell’ossigeno (SpO2) minore o uguale al 93% nell’ambiente circostante e che persiste per più di 7 giorni;

    - Diagnosi virologica di infezione di SARS-CoV-2 (infezione di SARS-CoV-2 confermata da un test di PCR) più di 3 giorni prima;

    - Avere una serie di patologie sistemiche concomitanti, condizioni o disordini che, in base all’opinione dell’investigator, potrebbero precludere la partecipazione allo studio;

    - Arruolamento in altri studi clinici interventistico che si realizzano in contemporanea nel corso dei 30 giorni;
    - presenza di comorbidità pericolose per la vita o altre condizioni mediche, che secondo l’opinione dell’investigator, potrebbero rendere il paziente non idoneo allo studio;
    - avere un’allergia o un ipersensbilità ai componenti dei farmaci dello studio;
    E.5 End points
    E.5.1Primary end point(s)
    A composite endpoint of either severe COVID-19 or hospitalization or access in an emergency department or death from any cause by day 29 after randomization. Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, AND lung infiltrates) and hypoxemia (SpO2 < 92% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher
    Un endpoint composito di COVID-19 grave o di ospedalizzazione o di accesso in un dipartimento di emergenza o di morte per qualsiasi causa dalla randomizzazione fino al giorno 29. Il COVID-19 grave è caratterizzato da un minimo di polmonite (febbre, tosse, tachIpnea, o dispnea, e infiltrazioni polmonari) e ipossia (SpO2 < 92% nell’ambiente circostante e/o distress respiratorio grave) e un punteggio sulla Scala di Progressione Clinica del WHO di 5 o più alto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    29 day
    29 giorni
    E.5.2Secondary end point(s)
    - Proportion of participants who experience hospitalization or Emergency Room (ER) visit within day 29 and within 90 days;
    - Proportion of participants experiencing severe COVID-19 by day 29 after randomization;
    - Variation of SARS-CoV-2 viral load measured by semi-quantitative RT-PCR between day of randomization and day 7, 14 and 29;
    - Proportion of participant with undetectable SARS-CoV-2 RNA at day 7, 14 and 29 after randomization;
    - Variation of symptoms score from day of randomization to days 7, 14, and 29 after randomization;
    - Proportion of participants demonstrating symptom resolution (i.e. scoring 0 in the WHO scale) at Days 7, 14 and 29 after randomization;
    - Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 29 after randomization;
    - Proportion of participants with severe adverse events (grade = 3 according to CTCAE) at day 7, 29 after randomization;
    - Variation of Hematology, chemistry, coagulation, and inflammatory markers between the day of randomization and day 7, 29 after randomization;
    - Proportion of SARS-CoV-2 spike mutation gene (including D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F and N439K) among participant experiencing the primary endpoint;
    - Proportion of SARS-CoV-2 spike mutation gene (including D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F and N439K) among participant with a detectable SARS-COV-2 viral load at day 29 after randomization
    - Proporzione di partecipanti che sperimentano l’ospedalizzazione o visita in Pronto soccorso entro i 29 giorni e I 90 giorni;
    - Proporzione di partecipanti che presentano COVID-19 grave dal giorno 29 dopo la randomizzazione;
    - Variazione della carica virale di SARS-CoV-2 misurata mediante RT-PCR semi-quantitativa tra il giorno della randomizzazione e il giorno 7, 14 e 29;
    - Proporzione di partecipanti con SARS-CoV-2 RNA non rilevabile al giorno 7, 14 e 29 dopo la randomizzazione;
    - Variazione dello score dei sintomi dal giorno di randomizzazione ai giorni 7,14 e 29 dopo la randomizzazione;
    - Proporzione di partecipanti che manifestano una risoluzione dei sintomi (i.e. con uno score 0 nella scala WHO) ai giorni 7, 14 e 29 dopo la randomizzazione.
    - La proporzione di parteicpanti con qualsiasi eventi avversi (di grado < o uguale a 2 secondo la CTCAE) al girono 7, 29 dopo la randomizzazione;
    - Proporzione dei partecipanti con eventi avversi gravi (di grado > o uguale a 3 secondo la CTCAE) al giorno 7,29 dopo la randomizzazione;
    - Variazione dei marker ematologici, di chimica, della coagulazione e infiammatori tra il giorno della randomizzazione e il giorno 7, 29 dopo la randomizzazione;
    - Proporzione della mutazione del gene per la proteina spike di SARS-CoV-2 (incluse D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F e N439K) tra partecipanti che sperimentano l’endpoint primario;
    - Proporzione della mutazione del gene per la proteina spike di SARS-CoV-2 (incluse D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F and N439K) tra partecipanti con una carica virale rilevabile per SARS-CoV-2 al giorno 29 dopo la randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    - within day 29 and within 90 days;
    - by day 29 after randomization;
    - between day of randomization and day 7, 14 and 29;
    - at day 7, 14 and 29 after randomization;
    - from day of randomization to days 7, 14, and 29 after randomization;
    - at Days 7, 14 and 29 after randomization;
    - at day 7, 29 after randomization;
    - at day 7, 29 after randomization;
    - between the day of randomization and day 7, 29 after randomization;
    - at day 29;
    - at day 29 after randomization
    - entro i 29 giorni e I 90 giorni;
    - dal giorno 29 dopo la randomizzazione;
    - tra il giorno della randomizzazione e il giorno 7, 14 e 29;
    - al giorno 7, 14 e 29 dopo la randomizzazione;
    - ai giorni 7,14 e 29 dopo la randomizzazione;
    - ai giorni 7, 14 e 29 dopo la randomizzazione.
    - al giorno 7, 29 dopo la randomizzazione;
    - al giorno 7,29 dopo la randomizzazione;
    - tra il giorno della randomizzazione e il giorno 7, 29 dopo la randomizzazione;
    - al giorno 29;
    - al giorno 29 dopo la randomizzazione
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial3
    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 concerned40
    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 e chiusura dei centri clinici
    LVLS e chiusura dei centri clinici
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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 state1550
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1550
    F.4.2.2In the whole clinical trial 1550
    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)
    At the end of the study, patients will be treated with the treatments required by normal clinical practice
    Al termine dello studio i pazienti saranno trattati con le cure previste dalla normale pratica clinica
    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 Decision2021-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-15
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