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    Summary
    EudraCT Number:2022-002741-18
    Sponsor's Protocol Code Number:GS-US-611-6273
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-13
    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 ConcernedSpain - AEMPS
    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
    Estudio en fase III, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de GS-5245 en el tratamiento de COVID-19 en participantes con alto riesgo de progresión de la enfermedad
    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
    Estudio de fase III para evaluar GS-5245 en participantes con COVID-19 que tienen una alta probabilidad de desarrollar enfermedad seria o grave
    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, Inc.
    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.3.2Product 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.3.8INN - Proposed INNNot available
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Enfermedad por el coronavirus de 2019 (COVID-19) en pacientes que tienen un alto riesgo de desarrollar enfermedad seria 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
    Enfermedad por el coronavirus de 2019 (COVID-19) en pacientes que tienen una alta probabilidad de desarrollar enfermedad seria 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
    • Evaluar la eficacia de GS-5245 en la reducción de la tasa de hospitalizaciones relacionadas con la COVID-19 o de muertes por cualquier 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
    Objetivos secundarios:
    • Evaluar la seguridad de GS-5245 administrado a participantes con COVID-19 no hospitalizados
    • Evaluar la eficacia de GS-5245 en la reducción de las hospitalizaciones por cualquier causa
    • Evaluar la eficacia de GS-5245 en la reducción de las visitas de atención médica (VAM) relacionadas con la COVID-19 o de las muertes por cualquier causa
    • Evaluar la eficacia de GS-5245 en la reducción de las VAM relacionadas con la COVID-19
    • Evaluar la eficacia de GS-5245 en la reducción de las muertes por cualquier causa
    • Evaluar el efecto de GS-5245 sobre la duración y gravedad de los síntomas
    • Evaluar la actividad antiviral de GS-5245 en la carga viral del SARS-CoV-2 en hisopado nasal el día 5

    Objetivos exploratorios:
    • Evaluar la carga viral del SARS-CoV-2 durante todo el periodo de evaluación
    • Evaluar la aparición de resistencia del virus a GS-5245
    • Evaluar el estado serológico 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
    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.
    Hay un subestudio FC intensivo opcional planeado en aproximadamente 30 participantes. A estos participantes se les recogerán muestras para FC intensiva los días 1 (después de la primera dosis) y 5 (dosis de la mañana) antes de la dosis (en el plazo de 1,0 horas antes de la dosis) 0,25, 0,5, 0,75, 1,5, 3, 4 horas después de la dosis. Consulte la Tabla 1 del Protocolo y la Sección 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.
    k.i. Interstitial lung disease
    k.ii. Pulmonary embolism
    k.iii. Pulmonary hypertension
    k.iv. Bronchiectasis
    k.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.
    Las participantes deben cumplir todos los siguientes criterios de inclusión a fin de ser aptos para participar en este estudio:
    1) Edad ≥18 años en la selección.
    2) Voluntad y capacidad para dar el consentimiento informado por escrito o con un representante legal que pueda darlo (cuando esté autorizado a nivel local y nacional).
    3) Infección por el SARS-CoV-2 confirmada mediante PCR o un análisis alternativo en un plazo ≤5 días antes de la aleatorización.
    4) Aparición inicial de signos/síntomas de COVID-19 en un plazo ≤5 días antes de la aleatorización con un número de signos/síntomas en la aleatorización ≥1 (sin incluir las alteraciones del gusto ni del olfato).
    5) Pacientes que no estén hospitalizados ni requieran hospitalización.
    6) Presencia de un número de factores de riesgo de progresión a enfermedad grave ≥1 (en no vacunados) o ≥2 (en vacunados en algún momento). Las personas vacunadas son aptas para la inclusión solo si han transcurrido un mínimo de 4 meses desde la dosis más reciente, incluidas las de refuerzo. Los factores de riesgo son los siguientes:
    a. Edad ≥50 años.
    b. Cáncer en curso o reciente (plazo ≤6 meses antes de la aleatorización) (distinto del cáncer de piel localizado).
    c. Infección por el virus de la inmunodeficiencia humana.
    d. Esplenectomía previa.
    e. Trasplante previo de órgano sólido, células madre o médula ósea.
    f. Trastornos sistémicos reumáticos o cutáneos.
    g. Uso de inmunosupresores sistémicos.
    h. Enfermedad cerebrovascular.
    i. Enfermedad cardiovascular, incluida la insuficiencia cardíaca.
    j. Enfermedad renal crónica (siempre que el participante no cumpla el criterio de exclusión 7).
    k. Enfermedad pulmonar crónica.
    k.i. Enfermedad pulmonar intersticial
    k.ii. Embolia pulmonar.
    k.iii. Hipertensión pulmonar
    k.iv. Bronquiectasia.
    k.v. Enfermedad pulmonar obstructiva crónica.
    l. Enfermedad hepática crónica.
    m. Fibrosis quística.
    n. Diabetes mellitus, tipo 1 y/o tipo 2.
    o. Trastornos del desarrollo neurológico y neurodegenerativos.
    p. Índice de masa corporal ≥25.
    q. 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 x upper limit of normal (ULN)
    b. Bilirubin ≥ 5 x 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.
    Los criterios de exclusión para la participación son los siguientes:
    1) Acceso previsto y uso de tratamientos autorizados o aprobados contra la COVID-19 durante la enfermedad en curso en un plazo <5 días después de la aleatorización (los tratamientos son nirmatrelvir/ritonavir, molnupiravir, remdesivir intravenoso [RDV, Veklury®], anticuerpos monoclonales).
    2) Haber recibido algún fármaco antiviral de acción directa aprobado, autorizado o en investigación contra el SARS-CoV-2 para el tratamiento de la COVID-19 en un plazo <28 días o <5 semividas, lo que suponga más tiempo, antes de la aleatorización.
    3) Necesidad prevista de hospitalización en un plazo <48 horas después de la aleatorización.
    4) Necesidad reciente de uso de oxígeno en un plazo <24 horas antes de la aleatorización.
    5) Sospecha o confirmación de infección sistémica activa concurrente distinta de la COVID-19 que pueda interferir en la evaluación de la respuesta al tratamiento del estudio.
    6) Cirrosis o lesión/insuficiencia hepática aguda.
    7) En diálisis o con antecedentes conocidos de insuficiencia renal de moderada a grave, o un valor conocido de Acr <60 ml/min (calculado mediante la fórmula de Cockcroft-Gault) o TFGe <60 ml/min/1,73 m2 en los últimos 6 meses. Los posibles participantes que cumplan los criterios analíticos pueden ser incluidos, si los resultados de los análisis disponibles antes de la administración de la dosis muestran que la función renal ya no cumple este
    criterio.
    8) Antecedentes conocidos de alguna de las siguientes anomalías analíticas (en un plazo <6 meses antes de la aleatorización), a menos que en la selección se confirme que se han resuelto y ya no se cumplen los criterios.
    a. Alanina aminotransferasa (ALT) ≥5 x límite superior de la normalidad (LSN)
    b. Bilirrubina ≥5 x LSN
    9) Prueba de embarazo en orina positiva o lactancia en la selección.
    10) Lactancia.
    11) Renuencia a utilizar un método anticonceptivo exigido por el protocolo.
    12) Hipersensibilidad conocida al medicamento del estudio, sus metabolitos o los excipientes de la formulación.
    13) Necesidad de tratamiento con alguno de los medicamentos prohibidos.
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of COVID-19–related hospitalization or all-cause death by Day 29
    • Porcentaje de hospitalizaciones relacionadas con la COVID-19 o de muertes por cualquier causa hasta el día 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    a varios puntos temporales a lo largo del estudio
    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
    Criterios de valoración secundarios:
    • Incidencia de AA surgidos durante el tratamiento y de resultados de laboratorio anómalos
    • Porcentaje de participantes hospitalizados por cualquier causa hasta el día 29
    • Porcentaje de participantes con VAM relacionadas con la COVID-19 o muerte por cualquier causa hasta el día 29
    • Porcentaje de participantes con VAM relacionadas con la COVID-19 hasta el día 29
    • Porcentaje de participantes fallecidos por cualquier causa hasta el día 29
    • Tiempo hasta el alivio sostenido de los síntomas de la COVID-19 a los que va dirigido el tratamiento
    • Cambio con respecto al inicio en la carga viral del SARS-CoV-2 el día 5

    Criterios de valoración exploratorios:
    • Cambio con respecto al inicio en la carga viral del SARS-CoV-2 en cada visita del estudio correspondiente
    • Porcentaje de participantes con resultado negativo en la prueba de detección del SARSCoV- 2 mediante reacción en cadena de la polimerasa (PCR) en cada visita del estudio correspondiente
    • Aparición de resistencia del virus a GS-5245
    • Títulos iniciales de anticuerpos anti-SARS-CoV-2
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study
    A varios puntos temporales a lo largo del estudio
    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 concerned25
    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 No
    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
    Ultima Visita Ultimo Paciente
    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).
    Voluntad y capacidad para dar el consentimiento informado por escrito o con un representante legal que pueda darlo (cuando esté autorizado a nivel local y nacional).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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 atención a largo plazo del participante seguirá siendo responsabilidad de su médico tratante primario. No hay disposición para la disponibilidad posterior al estudio.
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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