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    Summary
    EudraCT Number:2022-002741-18
    Sponsor's Protocol Code Number:GS-US-611-6273
    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:2022-11-18
    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 number2022-002741-18
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di GS-5245 nel trattamento del COVID-19 in partecipanti ad alto rischio di progressione della malattia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study for GS-5245 in Participants With COVID-19 Who Have a High Chance of Developing Serious or Severe Disease
    Studio volto a valutare GS-5245 in partecipanti con COVID-19 che presentano un elevato rischio di sviluppare malattia seria o grave
    A.3.2Name or abbreviated title of the trial where available
    GS-US-611-6273
    GS-US-611-6273
    A.4.1Sponsor's protocol code numberGS-US-611-6273
    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 SponsorGILEAD SCIENCES INCORPORATED
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityGreat Abington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    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 nameGS-5245
    D.3.2Product code [GS-5245]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2647441-36-7
    D.3.9.2Current sponsor codeGS-5245
    D.3.9.3Other descriptive nameGS-5245
    D.3.9.4EV Substance CodeSUB268881
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus disease 2019 (COVID-19) in patients who have a high risk of developing serious or severe illness
    Malattia di Coronavirus 2019 (COVID-19) in pazienti che hanno un alto rischio di sviluppare una malattia severa o grave
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19) in patients who have a high chance of developing serious or severe illness
    Malattia di Coronavirus 2019 (COVID-19) in pazienti che hanno un alto rischio di sviluppare una malattia severa o grave
    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 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 evaluate the efficacy of GS-5245 in reducing the rate of COVID-19–related hospitalization or all-cause death
    Valutare l’efficacia di GS-5245 nel ridurre il tasso di ricovero ospedaliero correlato a
    COVID-19 o decesso per qualsiasi causa
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    •To evaluate the safety of GS-5245 administered in nonhospitalized participants with COVID-19
    •To evaluate the efficacy of GS-5245 in reducing all-cause hospitalization
    •To evaluate the efficacy of GS-5245 in reducing COVID-19–related medically attended visits (MAVs) or all cause death
    •To evaluate the efficacy of GS-5245 in reducing COVID-19–related MAVs
    •To evaluate the efficacy of GS-5245 in reducing all cause deaths
    •To assess the impact of GS-5245 on symptom duration and severity
    •To evaluate the antiviral activity of GS-5245 on SARS-CoV-2 nasal swab viral load at Day 5

    Exploratory Objectives:
    •To evaluate SARS-CoV-2 viral load throughout the evaluation period
    •To evaluate the emergence of viral resistance to GS-5245
    •To evaluate anti-SARS-CoV-2 serostatus
    - Valutare la sicurezza di GS-5245 somministrato a partecipanti non ricoverati con COVID-19
    - Valutare l’efficacia di GS-5245 nel ridurre i ricoveri per qualsiasi causa
    - Valutare l’efficacia di GS-5245 nel ridurre le visite mediche (Medically Attended Visits,
    [MAV]) correlate al COVID-19 o i decessi per qualsiasi causa
    - Valutare l’efficacia di GS-5245 nel ridurre le MAV correlate al COVID-19
    - Valutare l’efficacia di GS-5245 nel ridurre i decessi per qualsiasi causa
    - Valutare l’impatto di GS-5245 sulla durata e sulla gravità dei sintomi
    - Valutare l’attività antivirale di GS-5245 sulla carica virale di SARS-CoV-2 in campioni di
    tampone nasale al Giorno 5

    Obiettivi esplorativi
    - Valutare la carica virale di SARS-CoV-2 per tutto il periodo di valutazione
    - Valutare l’insorgenza di resistenza virale a GS-5245
    - Valutare lo stato sierologico anti-SARS-CoV-2
    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: There is an optional intensive PK substudy planned in approximately 30 participants. These participants will have intensive PK samples collected on Days 1 (after the first dose) and 5 (morning dose) at predose (within 1.0-hour before dosing) 0.25, 0.5, 0.75, 1.5, 3, 4-hour postdose. See Protocol Table 1 and Section 6.3.3.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: C'è un sottostudio di PK intensiva facoltativo pianificato per circa 30 partecipanti.
    Questi partecipanti saranno sottoposti al prelievo di campioni per la PK intensiva nei Giorni
    1 (dopo la prima dose) e 5 (dose mattutina) pre-dose (entro 1.0 ora prima della
    somministrazione) a 0.25, 0.5, 0.75, 1.5, 3 e 4 ore post-dose.
    Tabella 1 del protocollo e sezione 6.3.3.
    E.3Principal inclusion criteria
    Participants must meet all the following inclusion criteria to be eligible for participation in this study:
    1) Aged = 18 years at screening.
    2) Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved).
    3) SARS-CoV-2 infection confirmed by PCR or an alternative assay = 5 days before randomization.
    4) Initial onset of COVID-19 signs/symptoms = 5 days before randomization with = 1 sign/symptom present at randomization (not including changes in taste or smell).
    5) Not currently hospitalized or requiring hospitalization.
    6) Presence of = 1 risk factor (if unvaccinated) or = 2 risk factors (if vaccinated at any point) for progression to severe disease. Vaccinated individuals are eligible for enrollment only if it has been at least 4 months since the most recent dose, including boosters. Risk factors are the following:
    a. Aged = 50 years.
    b. Current or recent (= 6 months prior to randomization) cancer (other than localized skin cancer).
    c. Have human immunodeficiency virus infection.
    d. Prior splenectomy.
    e. Prior solid organ, stem cell, or bone marrow transplant.
    f. Have systemic rheumatologic or dermatologic disorders.
    g. Use of systemic immunosuppressive agents.
    h. Have cerebrovascular disease.
    i. Have cardiovascular disease, including heart failure.
    j. Have chronic kidney disease (provided participant does not meet exclusion criterion 7).
    k. Have chronic lung disease
    i. Interstitial lung disease
    ii. Pulmonary embolism
    iii. Pulmonary hypertension
    iv. Bronchiectasis
    v. Chronic obstructive pulmonary disease
    l. Have chronic liver disease.
    m. Have cystic fibrosis.
    n. Have diabetes mellitus, type 1 and/or type 2.
    o. Have neurodevelopmental and neurodegenerative conditions.
    p. Have a body mass index = 25.
    q. Have sickle cell disease.
    L’eleggiblità a questo studio è subordinata alla soddisfazione da parte dei partecipanti di tutti i seguenti criteri di inclusione:
    1) Età =18 anni al momento dello screening.
    2) Volontà e capacità di fornire il consenso informato scritto o disponibilità di un tutore legale in grado di fornire il consenso informato (laddove approvato a livello locale e nazionale).
    3) Infezione da SARS-CoV-2 confermata mediante PCR o un test alternativo =5 giorni prima della randomizzazione.
    4) Insorgenza iniziale di segni/sintomi di COVID-19 =5 giorni prima della randomizzazione con =1 segno/sintomo presente alla randomizzazione (escluse alterazioni del gusto o dell’olfatto).
    5) Soggetti non attualmente ricoverati in ospedale o che richiedono il ricovero.
    6) Presenza di =1 fattore di rischio (se non vaccinati) o =2 fattori di rischio (se vaccinati in qualsiasi momento) per la progressione a malattia grave. I soggetti vaccinati sono idonei all’arruolamento solo se sono trascorsi almeno 4 mesi dalla dose più recente, compresi i richiami. I fattori di rischio sono i seguenti:
    a. Età =50 anni.
    b. Tumore (diverso dal tumore della pelle localizzato) attuale o recente (=6 mesi
    prima della randomizzazione).
    c. Infezione in corso da virus dell’immunodeficienza umana.
    d. Precedente splenectomia.
    e. Precedente trapianto di organo solido, cellule staminali o midollo osseo.
    f. Presenza di disturbi reumatologici o dermatologici sistemici.
    g. Uso di agenti immunosoppressori sistemici.
    h. Presenza di una malattia cerebrovascolare.
    i. Presenza di malattie cardiovascolari, compresa l’insufficienza cardiaca.
    j. Presenza di una malattia renale cronica (a condizione che il partecipante non
    soddisfi il criterio di esclusione 7).
    k. Presenza di una malattia polmonare cronica:
    i. malattia polmonare interstiziale
    ii. embolia polmonare
    iii. ipertensione polmonare
    iv. bronchiectasia
    v. malattia polmonare ostruttiva cronica
    l. Presenza di epatopatia cronica.
    m. Presenza di fibrosi cistica.
    n. Presenza di diabete mellito di tipo 1 e/o tipo 2.
    o. Presenza di condizioni neuroevolutive e neurodegenerative.
    p. Indice di massa corporea =25.
    q. Presenza di anemia falciforme.
    E.4Principal exclusion criteria
    Exclusion criteria for participation include:
    1) Anticipated access to and use of authorized or approved COVID-19 therapies during the
    current COVID-19 illness < 5 days after randomization (therapies include
    nirmatrelvir/ritonavir, molnupiravir, intravenous remdesivir [RDV, Veklury®], monoclonal
    antibodies).
    2) Received any approved, authorized, or investigational direct acting antiviral drug against
    SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is
    longer, before randomization.
    3) Anticipated need for hospitalization < 48 hours after randomization.
    4) New oxygen requirement < 24 hours before randomization.
    5) Suspected or confirmed concurrent active systemic infection other than COVID-19 that
    may interfere with the evaluation of response to the study intervention.
    6) Cirrhosis or acute liver injury/failure.
    7) Undergoing dialysis, or known history of moderate to severe renal impairment, or known
    CLcr < 60 mL/min (as calculated by Cockcroft-Gault) or eGFR < 60 mL/min/1.73 m²
    within the last 6 months. Potential participants meeting the laboratory criterion may be
    enrolled if test results available before dosing show that renal function no longer meets this
    criterion.
    8) Known history of any of the following abnormal laboratory results (< 6 months before
    randomization) unless confirmed as resolved to not meet criteria at screening.
    a. Alanine aminotransferase (ALT) = 5 ¿ upper limit of normal (ULN)
    b. Bilirubin = 5 ¿ ULN
    9) Positive urine pregnancy test at screening.
    10) Breastfeeding (nursing).
    11) Unwilling to use protocol-mandated birth control.
    12) Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
    13) Requirement for ongoing therapy with or prior use of any prohibited medications.
    I criteri di esclusione per la partecipazione includono:
    1) Accesso a e uso previsti di terapie anti-COVID-19 autorizzate o approvate durante l’attuale malattia da COVID-19 <5 giorni dopo la randomizzazione (le terapie includono nirmatrelvir/ritonavir, molnupiravir, remdesivir per via endovenosa [RDV, Veklury®], anticorpi monoclonali).
    2) Assunzione di qualsiasi farmaco antivirale ad azione diretta approvato, autorizzato o sperimentale contro SARS-CoV-2 per il trattamento del COVID-19 <28 giorni o <5 emivite, a seconda di quale sia il periodo più lungo, prima della randomizzazione.
    3) Necessità prevista di ricovero <48 ore dopo la randomizzazione.
    4) Ulteriore fabbisogno di ossigeno <24 ore prima della randomizzazione.
    5) Infezione sistemica attiva concomitante sospetta o confermata diversa da COVID-19 che potrebbe interferire con la valutazione della risposta al trattamento dello studio.
    6) Cirrosi o lesione/insufficienza epatica acuta.
    7) Soggetti sottoposti a dialisi o anamnesi nota di insufficienza renale da moderata a grave, o clearance della creatinina (CLcr) nota <60 ml/min (calcolata mediante la formula di Cockcroft-Gault) o velocità di filtrazione glomerulare stimata (estimated Glomerular
    Filtration Rate, [eGFR]) <60 ml/min/1,73 m² negli ultimi 6 mesi. I potenziali partecipanti che soddisfano il criterio di laboratorio possono essere arruolati se i risultati dei test disponibili prima della somministrazione mostrano che la funzione renale non soddisfa più tale criterio.
    8) Anamnesi nota di una qualsiasi delle seguenti anomalie nei risultati di laboratorio (<6 mesi prima della randomizzazione), a meno che non ne sia stata confermata la risoluzione per non soddisfare i criteri allo screening:
    a. alanina aminotransferasi (ALT) =5 x il limite superiore alla norma (Upper Limit of
    Normal, [ULN])
    b. bilirubina =5 x ULN
    9) Test di gravidanza sulle urine positivo allo screening.
    10) Allattamento al seno.
    11) Riluttanza a utilizzare un metodo contraccettivo previsto dal protocollo.
    12) Ipersensibilità nota verso il farmaco dello studio, i suoi metaboliti o l’eccipiente della formulazione.
    13) Necessità di assumere una terapia continuativa in concomitanza o precedente assunzione di un qualsiasi farmaco proibito.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of COVID-19–related hospitalization or all-cause death by Day 29
    Percentuale di ricoveri ospedalieri correlati a COVID-19 o decesso per qualsiasi causa entro il
    Giorno 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    In vari momenti dello studio
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    •Incidence of treatment-emergent AEs and laboratory abnormalities
    •Proportion of participants with all-cause hospitalization by Day 29
    •Proportion of participants with COVID 19 related MAVs or all-cause death by Day 29
    •Proportion of participants with COVID 19 related MAVs by Day 29
    •Proportion of participants with all-cause death at Day 29
    •Time to sustained alleviation of targeted COVID-19 symptoms
    •Change from baseline in SARS-CoV-2 viral load at Day 5

    Exploratory Endpoints:
    •Change from baseline in SARS-CoV-2 viral load at each applicable study visit
    •Proportion of participants with negative SARS CoV-2 polymerase chain reaction (PCR) at each applicable study visit
    •Emergence of viral resistance to GS-5245
    •Baseline levels of anti-SARS-CoV-2 antibodies
    Endpoint secondari
    - Incidenza di eventi avversi (EA) emergenti dal trattamento e anomalie di laboratorio
    - Percentuale di partecipanti con ricovero per qualsiasi causa entro il Giorno 29
    - Percentuale di partecipanti con MAV correlate al COVID-19 o decesso per qualsiasi causa entro il Giorno 29
    - Percentuale di partecipanti con MAV correlate al COVID-19 entro il Giorno 29
    - Percentuale di partecipanti con decesso per qualsiasi causa il Giorno 29
    - Tempo all’attenuazione sostenuta di sintomi mirati del COVID-19
    - Variazione rispetto al basale nella carica virale di SARS-CoV-2 al Giorno 5

    Endpoint esplorativo/i

    - Variazione rispetto al basale della carica virale di SARS-CoV-2 a ogni visita dello studio applicabile
    - Percentuale di partecipanti con reazione a catena della polimerasi (Polymerase Chain Reaction, [PCR]) negativa per SARS-CoV-2 ad ogni visita dello studio applicabile
    - Insorgenza di resistenza virale a GS-5245
    - Livelli basali di anticorpi anti-SARS-CoV-2
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    In vari momenti 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA144
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Colombia
    India
    Japan
    Kenya
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Singapore
    South Africa
    Taiwan
    Thailand
    France
    Poland
    Sweden
    Bulgaria
    Romania
    Spain
    Switzerland
    Czechia
    Germany
    Italy
    Denmark
    Hungary
    Portugal
    Turkey
    United Kingdom
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days5
    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: 2520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 630
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where locally and nationally approved).
    Disposti e in grado di fornire il consenso informato scritto, o con un rappresentante legale che possa fornire il consenso informato (dove a livello locale e nazionale approvato).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 3150
    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 long-term care of the participant will remain the responsibility of their primary treating physician. There is no provision for poststudy availability.
    La cura a lungo termine del partecipante rimarrà responsabilità del proprio medico curante principale. Non vi è alcuna disposizione per la disponibilità post-studio .
    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 Decision2022-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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