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    Summary
    EudraCT Number:2020-002871-36
    Sponsor's Protocol Code Number:VIR-7831-5001
    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:2022-08-23
    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 number2020-002871-36
    A.3Full title of the trial
    A randomized, multi-center, double-blind, placebo-controlled study to assess the safety and efficacy of monoclonal antibody VIR-7831 for the early treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized patients.
    Estudio aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia del anticuerpo monoclonal VIR-7831 para el tratamiento precoz de la enfermedad por coronavirus de 2019 (COVID-19) en pacientes no hospitalizados.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VIR-7831 for the early treatment of COVID-19 in outpatients
    VIR-7831 para el tratamiento precoz de la COVID-19 en pacientes no hospitalizados
    A.4.1Sponsor's protocol code numberVIR-7831-5001
    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 SponsorVir Biotechnology, 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 supportVir Biotechnology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressVicolo del Caldo 36
    B.5.3.2Town/ citySaronno (VA)
    B.5.3.3Post code21047
    B.5.3.4CountryItaly
    B.5.4Telephone number390297383850
    B.5.6E-mailsara.brevi@syneoshealth.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 VIR-7831
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNVIR-7831
    D.3.9.2Current sponsor codeVIR-7831
    D.3.9.3Other descriptive nameVIR-7831
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    D.3.11.13.1Other medicinal product typeVIR-7831 is a fully human IgG1κ mAb derived from the parental mAb S309, a potent mAb directed against the spike protein of SARS-CoV-2
    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 infusion
    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
    Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, the cause of coronavirus disease 2019 (COVID-19)
    Síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2), la causa de la enfermedad por coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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
    • Evaluate the efficacy of VIR-7831 versus placebo in preventing the progression of mild/moderate COVID-19
    Evaluar la eficacia del VIR-7831 frente al placebo en la prevención de la progresión de la COVID-19 leve o moderada
    E.2.2Secondary objectives of the trial
    • Determine the safety and tolerability of VIR-7831 compared to placebo
    • Evaluate the efficacy of VIR-7831 versus placebo in preventing COVID-19 progression at early timepoints
    • Evaluate the efficacy of VIR-7831 versus placebo in preventing COVID-19 respiratory disease progression (Days 8, 15, and 22, 29)
    • Evaluate the efficacy of VIR-7831 versus placebo in preventing mortality
    • Evaluate the impact of VIR-7831 versus placebo in the duration and severity of COVID-19 clinical symptoms
    • Evaluate the efficacy of VIR-7831 versus placebo in reducing duration of SARS-CoV-2 viral shedding
    • Assess the pharmacokinetics (PK) of VIR-7831 in serum
    • Assess the immunogenicity of VIR-7831
    - Evaluar la seguridad y la tolerabilidad del VIR-7831 en comparación con el placebo.
    - Evaluar la eficacia del VIR-7831 frente al placebo en la prevención de la progresión de la COVID-19 en puntos temporales tempranos.
    - Evaluar la eficacia del VIR-7831 frente al placebo en la prevención de la progresión de la enfermedad respiratoria de la COVID-19 (días 8, 15 y 22, 29).
    - Evaluar la eficacia del VIR-7831 frente al placebo en la prevención de la mortalidad
    - Evaluar el impacto del VIR-7831 frente al placebo en la duración y gravedad de los síntomas clínicos de la COVID-19.
    - Evaluar la eficacia del VIR-7831 frente al placebo en la reducción de la duración de la excreción del SARS-CoV-2.
    - Evaluar la farmacocinética (FC) del VIR-7831 en suero.
    - Evaluar la inmunogenia del VIR-7831.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Participants enrolled in the Lead-In phase will be assigned to an immunogenicity sub-study and have additional timepoints for PK blood sampling
    Los participantes incluidos en la fase de rodaje serán asignados a un subestudio de inmunogenia, en el que habrá puntos temporales adicionales para el muestreo de sangre para FC.
    E.3Principal inclusion criteria
    male and female subject who:
    1. Subjects aged 18 years and older at high risk of complications from COVID-19 disease including diabetes, obesity (BMI>30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, and moderate to severe asthma
    or
    2. Subjects ≥55 years old, irrespective of co-morbidities
    3. have a positive SARS-CoV-2 test result (by any validated test e.g. RT-PCR on any specimen type)
    - Oxygen saturation ≥94% on room air
    - Have COVID-19 defined by one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertion
    AND
    Less than or equal to 5 days from onset of symptoms
    4. No gender restrictions
    5. Female participants must meet and agree to abide by the following contraceptive criteria. Contraception use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
    - Is a woman of non-childbearing potential (WONCBP) as defined in [Section 10.4 of the protocol].
    OR
    - Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 of the protocol during the study intervention period and for up to one year after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
    A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention. See Section [8.2.5 Pregnancy Testing] of the protocol.
    - If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    - Additional requirements for pregnancy testing during and after study intervention are located in Section 10.2 of the protocol.
    The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
    6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol,
    OR
    If participants are not capable of giving written informed consent, alternative consent procedures will be followed and will be detailed in Section 9 of the full protocol
    sujetos hombres y mujeres:
    1. De 18 años o más con alto riesgo de complicaciones de la COVID-19, como diabetes, obesidad (IMC>30), nefropatía crónica, insuficiencia cardíaca congestiva, enfermedad pulmonar obstructiva crónica y asma de moderada a grave.
    o
    2. Sujetos ≥55 años, con independencia de las comorbilidades
    3. Con resultado positivo en la prueba del SARS-CoV-2 (en cualquier prueba validada, por ejemplo, RT-PCR en cualquier tipo de muestra)
    - Saturación de oxígeno ≥94 % en aire ambiental
    - Con COVID-19, lo que se define por uno o más de los siguientes síntomas: fiebre, escalofríos, tos, dolor de garganta, malestar, dolor de cabeza, dolor articular o muscular, alteración del olfato o el gusto, vómitos, diarrea, falta de aliento al realizar esfuerzo.
    Y
    Un plazo máximo de 5 días desde la aparición de los síntomas
    4. Sin restricciones por sexo
    5. Las mujeres participantes deben cumplir y aceptar los siguientes criterios anticonceptivos. El uso de anticonceptivos por parte de las mujeres debe ser acorde a la normativa local relativa a los métodos anticonceptivos para sujetos participantes en estudios clínicos
    Las mujeres podrán participar en el estudio si no están embarazadas o no están dando el pecho, y cumplen al menos una de las condiciones siguientes:
    - Mujeres que no sean fértiles, tal como se define en [el apartado 10.4 del protocolo].
    O
    - Mujeres fértiles que usen un método anticonceptivo altamente eficaz, con una tasa de fracaso <1 %, tal como se describe en el apartado 10.4 del protocolo durante el periodo de intervención del estudio y hasta un año después de la administración de la última dosis de la intervención del estudio. El investigador debe evaluar el potencial de fracaso del método anticonceptivo (por ejemplo, incumplimiento, inicio reciente) en relación con la primera dosis de la intervención del estudio.
    Las mujeres fértiles deben dar negativo en una prueba de embarazo de alta sensibilidad (en orina o suero, en función de los requisitos de la normativa local) a su ingreso en el hospital o antes de la administración de la primera dosis de la intervención del estudio. Véase el apartado [8.2.5 Prueba de embarazo] del protocolo.
    - Si la prueba de orina no puede confirmarse como negativa (por ejemplo, en caso de resultado ambiguo), será necesaria una prueba de embarazo en suero. En tales casos, la participante debe ser excluida de la participación si el resultado de la prueba de embarazo en suero es positivo.
    - Los requisitos adicionales para la prueba de embarazo durante y después de la intervención del estudio se encuentran en el apartado 10.2 del protocolo.
    El investigador es responsable de revisar los antecedentes médicos y menstruales y la actividad sexual reciente para mitigar el riesgo de inclusión de una mujer con un embarazo temprano no detectado
    6. Capaces de proporcionar un consentimiento informado firmado, lo que abarca el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (FCI) y en este protocolo,
    O
    Si los participantes no pueden otorgar su consentimiento informado por escrito, se seguirán procedimientos de consentimiento alternativos que se detallarán en el apartado 9 del protocolo completo
    E.4Principal exclusion criteria
    1. Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
    2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen.
    3. Participants who, in the judgement of the investigator are likely to die in the next 7 days.
    4. Severely immunocompromised participants including but not limited to cancer patients receiving immunosuppressive chemotherapy or immunotherapy, those with a solid organ transplant or allogeneic stem cell transplant within the last 3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to ≥ 20mg a day of prednisone or the systemic equivalent for over 2 weeks)
    5. Known hypersensitivity to any constituent present in the investigational product
    6. Previous anaphylaxis or hypersensitivity to a monoclonal antibody
    7. Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half lives of the investigational compound, whichever is longer.
    8. Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
    9. Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not be allowed for 4 weeks after dosing.
    10. Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months.
    11. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29
    1. Actualmente hospitalizado o que, a juicio del investigador es probable que deba hospitalizarse en las siguientes 24 horas
    2. Síntomas coherentes con COVID-19 grave, definidos como falta de aliento en reposo o dificultad respiratoria o que requiere oxigenoterapia.
    3. Participantes que, a juicio del investigador, es probable que fallezcan en los siguientes 7 días.
    4. Participantes gravemente inmunocomprometidos, lo que incluye, a título meramente enunciativo, a los pacientes con cáncer que reciben quimioterapia inmunodepresora o inmunoterapia, aquellos con un trasplante de órganos sólidos o un trasplante de células madre alogénicas en los últimos 3 meses, cualesquiera antecedentes de trasplante de corazón o pulmón o corticoesteroides generalizados a dosis altas a largo plazo (equivalente a ≥ 20 mg al día de prednisona o el equivalente generalizado durante más de 2 semanas)
    5. Hipersensibilidad conocida a cualquier componente presente en el producto en investigación
    6. Anafilaxia o hipersensibilidad previa a un anticuerpo monoclonal
    7. Inclusión en cualquier estudio de investigación de una vacuna en los últimos 180 días o cualquier otro estudio de un medicamento experimental en los 30 días anteriores al día 1 o en las 5 semividas del compuesto de investigación, lo que sea más largo.
    8. Inclusión en cualquier ensayo de una vacuna en investigación para el SARS-CoV-2.
    9. La recepción de cualquier vacuna en un plazo de 48 horas antes de la inclusión. No se permitirá la vacunación durante 4 semanas después de la administración de la dosis.
    10. La recepción de plasma de convaleciente de un paciente con COVID-19 recuperado o de Acm frente al SARS-CoV-2 en los últimos 3 meses.
    11. Los participantes para los que, a juicio del investigador, será improbable o imposible cumplir los requisitos del protocolo hasta el día 29.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants who have progression of COVID-19 through Day 29 as defined by:
    1. Hospitalization > 24 hours for acute management of illness
    OR
    2. Death
    Proporción de participantes que presenten una progresión de la COVID-19 el día 29, la cual se define como sigue:
    1. Hospitalización >24 horas para el tratamiento agudo de la enfermedad
    O
    2. Fallecimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Through day 29
    - Hospitalization > 24 hours for acute management of illness
    - Death
    - Durante el día 29
    - Hospitalización >24 horas para el tratamiento agudo de la enfermedad
    - Fallecimiento
    E.5.2Secondary end point(s)
    • Occurrence of adverse events (AEs)
    • Occurrence of serious adverse events (SAEs)
    • Occurrence of adverse events of special interest (AESI)
    • Incidence and titers (if applicable) of serum ADA to VIR-7831
    • VIR-7831 pharmacokinetics (PK) in serum
    • Proportion of participants who have progression of COVID-19 as defined by hospitalization >24 hrs or death at Day 8, Day 15, or Day 22
    • Proportion of participants who progress to develop severe and/or critical respiratory COVID-19 as manifested by the requirement for and method of supplemental oxygen at Day 8, Day 15, Day 22, or Day 29
    • Severity and duration of participant reported symptoms of COVID-19- related illness using the Flu-PRO patient-reported outcome instrument
    • Detection of SARS-CoV-2 in nasal secretions by PCR at baseline and during follow-up period through Day 29
    • 29-day, 60-day, and 90-day all-cause mortality
    • Aparición de acontecimientos adversos (AA)
    • Aparición de acontecimientos adversos graves (AAG)
    • Aparición de acontecimientos adversos considerados de especial interés (AAEI)
    • Incidencia y títulos (si procede) de AAF en suero a VIR-7831
    • Farmacocinética (FC) del VIR-7831 en suero
    • Proporción de participantes que presenten una progresión de la COVID-19, definida como una hospitalización >24 horas o fallecimiento los días 8, 15 o 22
    • Proporción de participantes que progresa para desarrollar COVID-19 respiratoria grave y/o crítica manifestada por la necesidad y el método de oxigenoterapia los días 8, 15, 22 o 29
    • Gravedad y duración de los síntomas de la enfermedad relacionados con la COVID-19 referidos por los participantes mediante el cuestionario de resultado referido por el paciente para la gripe (FLU-PRO)
    • Detección del SARS-CoV-2 en secreciones nasales mediante RCP al inicio del estudio y durante el periodo de seguimiento hasta el día 29
    • Mortalidad por cualquier causa a los 29, 60 y 90 días
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Adverse events will be assessed up to Week 12. Serious
    Adverse events (SAEs) will be assessed up to Week 24
    • >24 hrs or death at Day 8, Day 15, or Day 22
    • Proportion of subjects who progress to develop severe or critical COVID-19 at Day 8, Day 15, Day 22 or Day 29
    • At baseline and during follow-up period through Day 29
    • 29-day, 60-day, and 90-day all-cause mortality
    • Los acontecimientos adversos serán evaluado hasta la Semana 12. Los acontecimientos adversos graves (AAG) serán evaluados hasta la Semana 24
    • >24 horas o fallecimiento en los dñias 8, 15 o 22
    • Proporción de participantes que progresa para desarrollar COVID-19 grave o crítica los días 8, 15, 22 o 29
    • Al inicio del estudio y durante el periodo de seguimiento hasta el día 29
    • Mortalidad por cualquier causa a los 29, 60 y 90 días
    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) Yes
    E.7.1.1First administration to humans Yes
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Brazil
    Canada
    Chile
    Peru
    United States
    Spain
    United Kingdom
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study through to Week 24. The end of the study is defined as the date of the last contact of the last participant in the study
    Se considera que un paciente ha completado el studio si él/ella ha completado todas las fases del estudio hasta la Semana 24. El fin del estudio se define como la fecha del último contacto del último participante en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months6
    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: 960
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 1360
    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)
    None
    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 Decision2020-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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