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    Summary
    EudraCT Number:2020-001413-20
    Sponsor's Protocol Code Number:SILCOR-COVID19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-04-13
    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 number2020-001413-20
    A.3Full title of the trial
    Phase 2, randomized, open-label study to compare the efficacy and safety of siltuximab vs. corticosteroids in hospitalized patients with COVID19 pneumonia
    Estudio fase 2, aleatorizado, abierto para comparar la eficacia y
    la seguridad de siltuximab vs corticosteroides en pacientes
    hospitalizados con neumonía por COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of siltuximab vs. corticosteroids in hospitalized patients with COVID-19 pneumonia
    Eficacia y seguridad de siltuximab vs. corticosteroides en pacientes hospitalizados con neumonía por COVID-19
    A.4.1Sponsor's protocol code numberSILCOR-COVID19
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIDIBAPS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic
    B.5.2Functional name of contact pointFelipe García
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754002884
    B.5.5Fax number34932279877
    B.5.6E-mailfgarcia@clinic.cat
    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 Sylvant
    D.2.1.1.2Name of the Marketing Authorisation holderEUSA Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSiltuximab
    D.3.9.1CAS number 541502-14-1
    D.3.9.4EV Substance CodeSUB32552
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Urbason
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID19
    COVID19
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of siltuximab vs corticosteroids in hospitalized patients with COVID19 pneumonia by evaluating the number of admissions in the unit intensive care (ICU)
    Evaluar la eficacia de la administración de siltuximab vs corticosteroides en pacientes hospitalizados con neumonía por COVID19 mediante la evaluación del número de ingresos en la unidad de cuidados intensivos (UCI).
    E.2.2Secondary objectives of the trial
    -Stay in the ICU
    -Time to resolution of fever for at least 48 hours, without administration of antipyretics
    -Incidence of worsening in the oxygen therapy requirement
    -Duration of supplemental oxygen dependence
    -Incidence of the use of mechanical ventilation
    -Duration of the use of mechanical ventilation
    -Time to start of mechanical ventilation, non-invasive ventilation
    or use of high flow nasal cannula
    -Days of hospitalization
    -Mortality rate at 29 days
    -Incidence of SAEs
    -Incidence of invasive bacterial or fungal infections or opportunistic with grade 4 neutropenia
    -Incidence of invasive bacterial or fungal infections or opportunistic
    -Incidence of hypersensitivity reactions or reactions grade 2 related to the infusion
    -Incidence of GI perforations
    -Incidence of new serious secondary infections or worsening of existing infections
    -Changes in leukocytes, Hb, platelets, creatinine, bilirubin, ALT
    -Changes in inflammatory biomarkers
    -Changes in chest X-ray
    -Estancia UCI
    -Tiempo hasta resolución de fiebre durante 48 h sin administración de antipiréticos o alta hospitalaria
    -Incidencia de empeoramiento en cuanto a mayor oxigenoterapia
    -Duración de dependencia suplementaria de oxígeno
    -Incidencia de uso de ventilación mecánica
    -Duración de uso de ventilación mecánica
    -Tiempo hasta inicio de ventilación mecánica, ventilación no invasiva o uso de cánula nasal de alto flujo
    -Días de hospitalización
    -Tasa de mortalidad a 29 días
    -Incidencia de SAEs
    -Incidencia de infecciones bacterianas,fúngicas invasivas u oportunistas con neutropenia grado 4
    -Incidencia de infecciones bacterianas,fúngicas invasivas u oportunistas
    -Incidencia de reacciones de hipersensibilidad o RA >=2 relacionadas con la infusión
    -Incidencia de perforaciones GI
    -Incidencia de nuevas infecciones graves 2arias o empeoramiento
    -Cambios en leucocitos,Hb,plaquetas,creatinina,bilirrubina y ALT
    -Cambios en marcadores de inflamación
    -Cambios en Rx de tórax
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years old.
    2. Hospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:
    a) Non-critical patient with pneumonia in radiological progression and / or
    b) Patient with progressive respiratory failure at the last 24-48 hours.
    3. Laboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.
    4. Patient with a maximum O2 support of 35%
    5. Be willing and able to comply with the study related procedures / evaluations.
    6. Women of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).
    7. Written informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.
    When circumstances so allow, participants should sign the consent form.
    The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.
    1. Edad ≥ 18 años.
    2.Paciente hospitalizado (o documentación de un plan de
    hospitalización si el paciente se encuentra en un servicio de urgencias)
    con enfermedad de más de 5 días de duración con indicios de
    neumonía mediante radiografías torácicas/tomografía computarizada
    torácica y que cumple al menos uno de los siguientes requisitos:
    a) Paciente no crítico con neumonía en progresión radiológica y/o
    b) Paciente con insuficiencia respiratoria progresiva de 24-48 horas
    de duración.
    3. Infección por SARS-CoV-2 confirmada por laboratorio (mediante
    PCR) u otro análisis comercializado o de salud pública en cualquier
    muestra recogida 4 días antes de la aleatorización o criterio de COVID-
    19 siguiendo los criterios de diagnóstico definidos en ese momento en
    el centro.
    4. Paciente con un soporte de O2 máximo del 35%.
    5. Paciente dispuesto y/o tener la capacidad para cumplir con los
    procedimientos/evaluaciones relacionados con el estudio.
    6. Las mujeres en edad fértil* deben tener una prueba negativa de
    embarazo en suero antes de la inclusión en el estudio y deben
    comprometerse a utilizar métodos anticonceptivos altamente eficaces
    (dispositivo intrauterino, oclusión tubárica bilateral, pareja
    vasectomizada y abstinencia sexual).
    7. Paciente que otorgue el consentimiento informado por escrito. En
    caso que el paciente no pueda firmar el consentimiento informado, se
    obtendrá consentimiento informado oral por parte del representante
    legal o familiar (o, en su defecto, testigo imparcial ajeno al equipo
    investigador) por teléfono. Cuando las circunstancias lo permitan, el
    paciente firmará el consentimiento informado. La confirmación de
    consentimiento oral se documentará a través de un documento de
    confirmación de consentimiento oral por emergencia COVID-19 como
    constancia de que se ha obtenido el consentimiento oral.
    E.4Principal exclusion criteria
    1. Patient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study.
    2. Presence of any of the following abnormal analytical values at the time of the inclusion in the study:
    - absolute neutrophil count (RAN) less than 2000 / mm3;
    - AST or ALT> 5 times the ULN;
    - platelets <50,000 per mm3.
    3. In active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.
    4. Known active tuberculosis (TB) or known history of TB uncompleted treatment.
    5. Patients with active systemic bacterial and / or fungal infections.
    6. Participants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.
    7. Patients who do not have entry criteria in the Intensive Care Unit.
    8. Pregnancy or lactation.
    9. Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).
    1. Paciente que, a criterio del investigador, es poco probable que
    sobrevivan > 48 horas des de la inclusión en el estudio.
    2. Presencia de cualquiera de los siguientes valores analíticos
    anormales en el momento de la inclusión en el estudio:
    - recuento absoluto de neutrófilos (RAN) inferior a 2000/mm3;
    - AST o ALT > 5 veces el LSN;
    - plaquetas < 50 000 por mm3.
    3. En tratamiento activo con inmunodepresores o tratamiento
    prolongado previo (más de 3 meses) de corticosteroides orales para
    una enfermedad no relacionada con COVID-19 a una dosis superior a
    10 mg de prednisona o equivalente por día.
    4. Tuberculosis (TB) activa conocida o antecedentes conocidos de TB
    tratada de forma incompleta.
    5. Pacientes con infecciones bacterianas y/o fúngicas sistémicas
    activas.
    6. Participantes que, a criterio del investigador, no sean aptos para
    participar, independientemente del motivo, incluidas afecciones
    médicas o clínicas, o participantes potencialmente en riesgo de no
    cumplir los procedimientos del estudio.
    7. Pacientes que no tengan criterios de entrada en la Unidad de
    Cuidados Intensivos.
    8. Embarazo o lactancia.
    9. Hipersensibilidad conocida a siltuximab o a alguno de los sus
    excipientes (
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients requiring ICU admission at any time within the study period.
    Proporción de pacientes que requieren de ingreso en la UCI en cualquier momento dentro del periodo del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    29 days
    29 días
    E.5.2Secondary end point(s)
    1. Days of stay in the ICU during the study period.
    2. Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge, whichever occurs first
    3. Proportion of patients with a worsening requirement of supplemental oxygen at 29 days.
    4. Days until improvement in oxygenation (SpO2 / FiO2 increase of 50 or more in comparison with SpO2 / FiO2 nadir) for at least 48 hours, depending on clinical severity at 29 days.
    5. Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.
    6. Proportion of patients using mechanical ventilation at 29 days.
    7. Days with use of mechanical ventilation at 29 days.
    8. Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.
    9. Days of hospitalization among survivors at 29 days.
    10. Mortality rate from any cause at 29 days.
    11. Proportion of patients with serious adverse events at 29 days.
    12. Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute [RAN] <500 / mm3) at 29 days.
    13. Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.
    14. Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.
    15. Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.
    16. Proportion of patients with gastrointestinal perforation at 29 days.
    17. Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.
    18. Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.
    19. Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.
    20. Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.
    21. Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.
    22. Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.
    23. Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9.

    24. Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.
    25. Changes from baseline in chest Rx at days 1, 3 and 5.
    1. Días de estancia en la UCI durante el periodo del estudio.
    2. Días hasta la resolución de fiebre definida como temperatura
    corporal (axilar ≤ 36,6°C)
    durante al menos 48 horas, sin administración de antipiréticos o hasta
    el alta hospitalaria , lo que ocurra primero según la gravedad clínica.
    3. Proporción de pacientes con un empeoramiento en la necesidad de
    oxígeno suplementario a lo largo de 29 días.
    4.Días hasta la mejora en la oxigenación (aumento de SpO2/FiO2 de 50
    o superior en comparación con la SpO2/FiO2 nadir) durante al menos
    48 horas, según la gravedad clínica a los 29 días.
    5. Días con hipoxemia (SpO2 < 93 % en aire ambiente o que requiere
    oxígeno suplementario o soporte de ventilación mecánica)
    6. Proporción de pacientes con uso de ventilación mecánica durante
    29 días.
    7. Días con uso de ventilador mecánico durante 29 días.
    8. Días hasta el inicio de uso de ventilación mecánica, ventilación no
    invasiva o uso de cánula nasal de alto flujo en caso de no haber
    requerido previamente de dichas intervenciones desde el inicio del
    estudio a los 29 días.
    9. Días de hospitalización entre los supervivientes durante 29 días.
    10. Tasa de mortalidad por cualquier causa a los 29 días.
    11.Proporción de pacientes con acontecimientos adversos graves a los
    29 días.
    12. Proporción de pacientes con infecciones bacterianas o fúngicas
    invasivas clínicamente significativas u oportunistas con neutropenia de
    grado 4 (recuento absoluto de neutrófilos [RAN] < 500/mm3) a los 29
    días.
    13. Proporción de pacientes con infecciones bacterianas o fúngicas
    invasivas clínicamente significativas u oportunistas a los 29 días.
    14. Proporción de pacientes con reacciones adversas de grado 2 o
    superior relacionadas con la infusión de los tratamientos en estudio a
    los 29 días.
    15. Proporción de pacientes con reacciones de hipersensibilidad de
    grado 2 o superior relacionadas con la administración de los
    tratamientos en estudio a los 29 días.
    16. Proporción de pacientes con perforación gastrointestinal a los 29
    días.
    17. Proporción de pacientes con infecciones graves secundarias
    confirmadas por laboratorio o empeoramiento de infecciones
    existentes a los 29 días.
    18. Cambios desde los valores basales en los niveles plasmáticos de leucocitos a los días 1, 3, 5, 7 y 9 en caso de seguir hospitalizados.
    19. Cambios desde los valores basales en los niveles plasmáticos de
    hemoglobina a los días 1, 3, 5, 7 y 9 en caso de seguir hospitalizados.
    20. Cambios desde los valores basales en los niveles plasmáticos de
    plaquetas a los días 1, 3, 5, 7 y 9 en caso de seguir hospitalizados.
    21. Cambios desde los valores basales en los niveles plasmáticos de
    creatinina a los días 1, 3, 5, 7 y 9 en caso de seguir hospitalizados.
    22. Cambios desde los valores basales en los niveles plasmáticos de
    bilirrubina total a los días 1, 3, 5, 7 y 9 en caso de seguir hospitalizados.
    23. Proporción de pacientes con ALT≥ 3 veces LSN (para pacientes con
    valores iniciales normales) o > 3 veces LSN Y al menos 2 veces más del
    valor inicial (para pacientes con valores iniciales anormales).
    24. Cambios desde los valores basales en los biomarcadores
    plasmáticos (PCR, linfocitos, ferritina, d-dímero y LDH) a los 1,3 y 5
    días.
    25. Cambios desde los valores basales en la Rx de tórax a los 1,3 y 5
    días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    29 days
    29 days
    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 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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Última visita último paciente
    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 days45
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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
    In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.
    En
    caso que el paciente no pueda firmar el consentimiento informado, se
    obtendrá consentimiento informado oral por parte del representante
    legal o familiar (o, en su defecto, testigo imparcial ajeno al equipo
    investigador) por teléfono
    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)
    Available treatment for that condition
    Tratamiento disponible para la enfermedad en 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 Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-06
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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