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    Summary
    EudraCT Number:2020-001696-32
    Sponsor's Protocol Code Number:GC2004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-08
    Trial results View 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 number2020-001696-32
    A.3Full title of the trial
    A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) versus SMT alone in Hospitalized Subjects with COVID-19
    Estudio piloto multicéntrico, aleatorizado, abierto y con grupos paralelos para evaluar la seguridad y eficacia de Inmunoglobulina Intravenosa (IGIV) a altas dosis junto con el tratamiento médico estándar (TME) en comparación con el TME solo en sujetos hospitalizados con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety study of IVIG in hospitalized subjects with COVID-19
    Estudio de eficacia y seguridad de IGIV en sujetos hospitalizados con COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Study to Evaluate the Safety and Efficacy of High Dose IVIG in Patients with Mild/Moderate COVID19
    Estudio para evaluar la seguridad y eficacia de la IGIV a altas dosis en pacientes con COVID19
    A.4.1Sponsor's protocol code numberGC2004
    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 SponsorInstituto Grifols, S.A
    B.1.3.4CountrySpain
    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 supportInstituto Grifols, S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Grifols, S.A
    B.5.2Functional name of contact pointDepartment of Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAv. Generalitat 152
    B.5.3.2Town/ citySant Cugat del Vallès (Barcelona)
    B.5.3.3Post code08174
    B.5.3.4CountrySpain
    B.5.4Telephone number34935712000
    B.5.5Fax number34935712482
    B.5.6E-mailIGregulatory.affairs@grifols.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 Yes
    D.2.1.1.1Trade name Flebogamma 5% DIF
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNHuman normal immunoglobulin (IVIg)
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 Yes
    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 Yes
    D.2.1.1.1Trade name Flebogamma 10% DIF
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNHuman normal immunoglobulin (IVIg)
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Patients with Mild to Moderate Coronavirus Disease (COVID-19)
    Pacientes con Enfermedad por Coronavirus (COVID-19) leve o moderada
    E.1.1.1Medical condition in easily understood language
    Therapy for subjects suffering mild to moderate Coronavirus Disease (COVID-19)
    Terapia para pacientes que padecen la enfermedad por Coronavirus (COVID-19) leve o moderada
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus 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 determine if high dose IVIG plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized subjects with COVID-19.
    Determinar si altas dosis de IGIV junto con TME puede reducir la proporción de sujetos que mueren o requieren admisión en la unidad de cuidados intensivos (UCI) el día 29, o antes, o sujetos que sean dependientes de dispositivos de oxígeno de alto flujo o ventilación mecánica invasiva en el día 29 en comparación con el TME solo en sujetos hospitalizados con COVID-19.
    E.2.2Secondary objectives of the trial
    To compare high dose IVIG plus SMT versus SMT alone with regard to clinical efficacy as assessed by clinical severity, duration of hospital stay, dependency on oxygen or new need for ventilatory support, clinical response criteria including National Early Warning Score (NEWS), and clinical status scale through Day 29 in hospitalized subjects with COVID-19.
    Comparar altas dosis de IGIV junto con TME versus solamente el TME en relación a la eficacia clínica evaluada a través de la severidad clínica, la duración de la estancia en hospital, la dependencia de oxígeno o necesidad nueva de asistencia respiratoria, los criterios de respuesta clínica incluyendo la puntuación de alerta temprana nacional (NEWS) y la escala de estado clínico hasta el día 29 en sujetos hospitalizados con COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hospitalized male or female patient ≥ 18 years of age at time of Screening who is being treated for COVID-19.
    2.Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen <72 hours prior to randomization.
    3.COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging (Chest X-Ray, CT scan, etc.)
    4.PaO2/FIO2 ratio > 300 to ≤ 400 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air])
    5.Any One of the following related to COVID-19: i. Ferritin > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 mg/L
    6.Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides oral informed consent prior to initiation of any study procedures.
    Note: In the event that a subject is not be able to consent for himself/herself prior to initiation of any study procedures, a legal representative or a nearest relative or relative by marriage will provide oral informed consent on behalf of the subject. If the legal representative or a nearest relative or relative by marriage is quarantined because of COVID-19 emergency, informed consent will be provided orally by a phone call and documented in the subject’s medical notes. This will be recorded in the medical history with the following paragraph “I have explained to the patient [representative] the characteristics and objective of the study, its risks and potential benefits. I have been able to answer your questions and I affirm that this patient [representative] has given his oral consent ”. Subsequently, and when possible, the patient's written consent will be obtained (Ethics Committee approved version, which will be signed by the researcher and the patient).
    1.Hombre o mujer hospitalizados ≥ 18 años de edad en el momento de la selección que estén siendo tratados por COVID-19.
    2.Tener infección de novo por coronavirus (SARS-CoV-2) confirmada en laboratorio según determinación por PCR ([RT]-PCR) u otra prueba comercial o ensayo de salud pública en cualquier espécimen < 72 horas previo a la aleatorización.
    3.Enfermedad por COVID-19 (síntomas) de cualquier duración con infiltrados radiográficos de imagen (radiografía de pecho, tomografía computarizada, etc.)
    4.Ratio PaO2/FIO2 > 300 a ≤ 400 mm Hg (es decir, oxígeno arterial en mm Hg dividido por la concentración de oxígeno arterial inspirado [por ejemplo, 0.21 en aire ambiental])
    5.Cualquier de los siguientes relacionados con COVID-19: i. Ferritina > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dímeros > rango de referencia, o Proteína C-reactiva (CRP) iv. > 40 mg/L
    6.Sujeto (o un representante legal o un pariente cercano o un pariente por matrimonio, según proceda) que proporcione oralmente el consentimiento informado (CI) previo a iniciar cualquier procedimiento del estudio. Nota: El sujeto puede no ser capaz de consentir por él/ella mismo/a previo al inicio de cualquier
    procedimiento del estudio. En esta situación, un representante legal o un pariente cercano o un
    pariente por matrimonio proporcionará oralmente el consentimiento informado en nombre del sujeto. Si el representante legal o el pariente cercano o el pariente por matrimonio está en cuarentena debido a la emergencia por COVID-19, el consentimiento informado se proporcionará oralmente a través de una llamada telefónica y se documentará en la historia médica del sujeto.
    Este procedimiento se documentará en la historia médica del sujeto de la siguiente manera: "He explicado al paciente (representante) las características y el objetivo de este estudio, así como sus riesgos y beneficios potenciales. He podido responder a sus preguntas y afirmo que este paciente (representante) ha dado su consentimiento oralmente". Posteriormente, y cuando sea posible, se obtendrá el consentimiento del paciente por escrito (la versión aprobada por el Comité Ético, que será firmada por el paciente y el investigador.
    E.4Principal exclusion criteria
    1.Patient requires invasive mechanical ventilation or ICU admission
    2.Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
    3.The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or commercial immunoglobulin.
    4.Patient has known (documented) hereditary fructose intolerance (HFI)
    5.A medical condition in which the infusion of additional fluid is contraindicated (eg, decompensated congestive heart failure or renal failure with fluid overload)
    6.Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed
    7.Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past
    8.Subjects with current or prior (within the past 1 month) myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event.
    9.Patients with limitations of therapeutic effort (eg, ‘do not resuscitate’ status).
    10.Female subjects who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
    11.Patients participating in another interventional clinical trial with investigational medical product or device
    1.Pacientes que requieran ventilación mecánica invasiva o admisión en la UCI.
    2.Evidencia clínica de cualquier enfermedad aguda o crónica significativa que, en la opinión del investigador, pueda poner al sujeto bajo un riesgo médico indebido.
    3.El sujeto haya tenido una reacción anafiláctica grave conocida (documentada) a la sangre, derivados de la sangre o productos plasmáticos o inmunoglobulinas comerciales.
    4.El paciente tenga intolerancia hereditaria a la fructosa (IHF) conocida (documentada).
    5.Una condición médica en la que la infusión adicional de fluidos sea contraindicada (por ejemplo, insuficiencia cardíaca congestiva descompensada o insuficiencia renal con sobrecarga de líquido).
    6.Choque sin respuesta a la carga de volumen y/o vasopresores múltiples y acompañado de fallo multiorgánico considerado por el investigador principal sin posibilidad de ser revertido.
    7.Sujetos con complicaciones trombóticas conocidas (documentadas) por terapia con IGIV policlonales en el pasado.
    8.Sujetos con infarto de miocardio en este momento o previo (durante el pasado mes), accidente cerebral vascular, trombosis venosa profunda o evento tromboembólico.
    9.Pacientes con limitación de esfuerzo terapéutico (por ejemplo, estado de “no reanimación”).
    10.Mujeres embarazadas o en edad fértil que den positivo en la prueba de embarazo en sangre o en la prueba basada en gonadotropina coriónica humana (GCH) en orina en la visita de selección/inicio.
    11.Sujetos que estén participando en otro ensayo clínico intervencional.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the proportion of subjects dying or requiring ICU admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29.
    La variable de eficacia primaria es la proporción de sujetos que mueren o requieren admisión en la UCI el día 29 o antes, o que dependen de ventilación mecánica invasiva en el día 29.
    E.5.1.1Timepoint(s) of evaluation of this end point
    through Day 29
    durante el estudio hasta el día 29
    E.5.2Secondary end point(s)
    •Assessment of Clinical Severity: Change in NEWS from baseline (Day 1 through Day 29)
    The NEWS has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness [Alert, Voice, Pain, Unresponsive]).
    •Time to clinical response: NEWS ≤ 2 maintained for 24 hours, Day 1 through Day 29
    •Time to hospital discharge: defined as duration of hospitalization from Day 1 of study
    •If admitted to ICU post randomization: Duration of ICU stay through Day 29
    •Duration of any oxygen use Day 1 through Day 29
    •If requiring mechanical ventilation post randomization: Duration mechanical ventilation through Day 29
    •Absolute value and mean change from baseline in the Ordinal scale Day 1 through Day 29:
    The Ordinal scale is as follows:
    1) Death;
    2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    3) Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4) Hospitalized, requiring supplemental oxygen;
    5) Hospitalized, not requiring supplemental oxygen;
    6) Not hospitalized, limitation on activities;
    7) Not hospitalized, no limitations on activities.
    •Proportion (percentage) of subjects in each severity category of the 7-point Ordinal scale at Day 15 and Day 29
    •Time to sustained normalization of temperature and proportion of patients with normalization of fever at all time points, defined as temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours
    •Number of subjects who develop Acute Respiratory Distress Syndrome (ARDS) through Day 29
    •Length of time to clinical progression through Day 29 (defined as the time to death, mechanical ventilation, or ICU admission)
    •Evaluación de la severidad clínica: cambios en NEWS desde el inicio (desde el día 1 hasta el día 29).
    La puntuación NEWS ha demostrado una habilidad para discriminar pacientes en riesgo de resultados bajos. Esta puntuación está basada en 7 parámetros clínicos (frecuencia respiratoria, saturación de oxígeno, oxígeno suplementario, temperatura, presión sanguínea sistólica, frecuencia cardíaca, nivel de conciencia [alerta, voz, dolor, inconsciencia]).
    •Tiempo hasta la respuesta clínica: NEWS ≤ 2 mantenido durante 24 horas, del día 1 hasta día 29.
    •Tiempo hasta el alta hospitalaria: definida como la duración de la hospitalización desde el día 1 hasta el día 29.
    •Si se le admite en la UCI después de la aleatorización: duración de la estancia en la UCI hasta el día 29.
    •Duración del uso de cualquier oxígeno del día 1 al día 29.
    •Si requiere ventilación mecánica post aleatorización: duración de la ventilación mecánica del día 1 al día 29.
    •Valor absoluto y cambio medio desde el inicio del día 1 al día 29 en la puntuación de la escala Ordinal:
    La puntuación de la escala Ordinal es según sigue:
    1) Muerte;
    2) Hospitalizado, en ventilación mecánica invasiva o oxigenación por membrana extracorpórea (ECMO);
    3) Hospitalizado, en ventilación no invasiva o dispositivos de oxígeno de alto flujo;
    4) Hospitalizado, con requerimiento de oxígeno suplementario;
    5) Hospitalizado, sin requerimiento de oxígeno suplementario;
    6) No hospitalizado, limitación en actividades;
    7) No hospitalizado, sin limitación en actividades.
    •Proporción (porcentaje) de sujetos en cada categoría de severidad de la puntuación de la escala Ordinal de 7 puntos el día 15 y el día 29.
    •Tiempo hasta la normalización sostenida de la temperatura y la proporción de pacientes con normalización de la fiebre en todos los tiempos, definido como temperatura < 36.6 °C axilar, < 37.2 °C oral, o < 37.8 °C rectal sostenida durante al menos 24 horas.
    •Número de sujetos que desarrollan Síndrome de Distrés Respiratorio Agudo (ARDS) del día 1 al día 29.
    •Tiempo transcurrido hasta la progresión clínica del día 1 al día 29 (definido como tiempo hasta la muerte, ventilación mecánica o admisión en la UCI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    through Day 29
    a lo largo del estudio hasta el día 29
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento Médico Estándar
    Standard Medical Treatment
    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 concerned6
    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 No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under sedation.
    Sujetos bajo sedación.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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
    Ninguno
    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 Decision2020-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-03
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