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    Summary
    EudraCT Number:2020-002713-17
    Sponsor's Protocol Code Number:GA42469
    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:2020-07-20
    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 number2020-002713-17
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF
    MSTT1041A OR UTTR1147A IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA
    ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO,
    DOBLE CIEGO Y CONTROLADO CON PLACEBO, PARA
    EVALUAR LA SEGURIDAD Y LA EFICACIA DE MSTT1041A
    O UTTR1147A EN PACIENTES CON NEUMONÍA GRAVE
    CAUSADA POR COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients with Severe Covid-19 Pneumonia
    Estudio para evaluar la seguridad y la eficacia de MSTT1041A o UTTR1147A en pacientes con neumonía grave causada por Covid-19
    A.3.2Name or abbreviated title of the trial where available
    COVASTIL
    COVASTIL
    A.4.1Sponsor's protocol code numberGA42469
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namen/a
    D.3.2Product code RO7021610/F01 (Active)
    D.3.4Pharmaceutical form 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 INNn/a
    D.3.9.2Current sponsor codeRO7021610
    D.3.9.3Other descriptive nameUTTR1147A, IL22-Fc, IL-22Fc
    D.3.9.4EV Substance CodeSUB179397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 typeHuman interleukin-22 (IL-22) fusion protein
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAstegolimab
    D.3.2Product code RO7187807/F01
    D.3.4Pharmaceutical form Solution for injection/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 INNAstegolimab
    D.3.9.2Current sponsor codeRO7187807
    D.3.9.3Other descriptive nameMSTT1041A, anti- ST2 (IgG2) human monoclonal antibody
    D.3.9.4EV Substance CodeSUB182263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 Yes
    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 typehuman immunoglobulin (Ig) G2 monoclonal antibody
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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 coronavirus disease 2019 (COVID-19) pneumonia
    Enfermedad coronavirus grave 2019 (COVID-19) neumonía
    E.1.1.1Medical condition in easily understood language
    Coronaviruses are a family of viruses that typically cause the common cold. SARS-CoV 2 is a strain of coronavirus that can cause pneumonia (a severe lung infection) and respiratory failure.
    Los coronavirus son una familia de virus q típicamente causan el resfriado común. SARS-CoV 2 es una cepa de coronavirus q puede causar neumonía (infección pulmonar grave) e insuficiencia respiratoria.
    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 LLT
    E.1.2Classification code 10084383
    E.1.2Term Novel COVID-19-infected pneumonia
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 100000004862
    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 MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with standard of care (SOC) on the basis of clinical status assessed using a 7-category ordinal scale at Day 28
    Evaluar la eficacia de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tratamiento habitual basándose en el estado clínico evaluado mediante una escala ordinal de 7 categorías el día 28
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with SOC on the basis of time to clinical improvement, time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status, incidence of mechanical ventilation, ventilator-free days to Day 28, incidence and duration of intensive care unit (ICU) stay, time to clinical failure, mortality rate, time to hospital discharge or “ready for discharge”, duration of supplemental oxygen, duration of hypoxemia, and proportion of patients alive and free of respiratory failure
    • To evaluate the safety of MSTT1041A compared with placebo and of UTTR1147A compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia
    • To characterize the pharmacokinetic profile of MSTT1041A and UTTR1147A
    • To evaluate the immune response to UTTR1147A and MSTT1041A
    -Evaluar la eficacia de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tto habitual basándose en Tiempo hasta la mejoría clínica, tiempo hasta la mejoría de al menos 2 categorías con respecto al momento basal en una escala ordinal de 7 categorías del estado clínico, Incidencia de ventilación mecánica, Días sin respirador hasta el día 28, Incidencia y duración de estancia en la UCI, Tiempo hasta el fracaso clínico, Tasa de mortalidad, Tiempo hasta el alta hospitalaria o “listo para el alta”, Duración de la oxigenoterapia, Duración de la hipoxemia y Proporción de pacientes vivos y sin insuficiencia respiratoria.
    - Evaluar la seguridad de MSTT1041A en comparación con el placebo y de UTTR1147A en comparación con el placebo en combinación con el tto habitual para la neumonía grave por el virus de la covid-19
    - Caracterizar los perfiles FC de MSTT1041A y UTTR1147A
    - Evaluar la respuesta inmunitaria a UTTR1147A y MSTT1041A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years
    • Hospitalized with COVID-19 pneumonia confirmed per WHO criteria and evidenced by chest X-ray or CT scan
    • Peripheral capillary oxygen saturation (SpO2) <= 93% or partial pressure of oxygen/fraction of inspired oxygen <= 300 mmHg or requiring supplemental oxygen to maintain SpO2 > 93%
    -Edad>=18 years
    -Hospitalización debida a neumonía por el virus de la covid-19 confirmada según los criterios de la OMS y demostrada por radiografía de tórax o TC
    -Saturación de oxígeno capilar periférica (SpO2) <= 93 % o presión parcial de oxígeno (PaO2)/fracción de oxígeno inspirado (FiO2) <= 300 mm Hg o necesidad de oxigenoterapia para mantener la SpO2> 93 %
    E.4Principal exclusion criteria
    • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
    • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
    • Participating in another clinical drug trial
    • Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days prior to initiation of study drug
    • Use of Janus kinase inhibitor within 30 days or 5 drug elimination half-lives prior to screening
    • Have received high-dose systemic corticosteroids within 72 hours prior to Day 1
    • Known HIV infection with CD4< 200 cells/micro liter or <14% of all lymphocytes
    • Alanine aminotransferase and aspartate aminotransferase >10× upper limit of normal (ULN) detected at screening
    • History of anaplastic large-cell lymphoma or mantle-cell lymphoma
    • History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
    • Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure) as assessed by the investigator assessment, ECG, laboratory assessment, or echocardiographic data
    • History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment
    -Cualquier enfermedad grave o anomalía analítica que, en opinión del investigador, descarte la
    participación segura del paciente en el estudio y su finalización.
    - En opinión del investigador, la progresión a la muerte es inminente e inevitable en las 24 horas siguientes, con independencia de la administración de tratamientos
    - Participación en otro ensayo clínico con fármacos
    - Tratamiento con un fármaco en investigación (que no sea para la COVID-19) en el plazo de
    5 semividas o 30 días (lo que dure más tiempo) antes del inicio del fármaco del estudio.
    - Uso de un inhibidor de la cinasa Jano (JAK) en los 30 días previos a la selección o el equivalente a 5 semividas de eliminación del fármaco
    -Haber recibido corticosteroides sistémicos en dosis altas en las 72 horas previas al día 1.
    - Infección conocida por el VIH con CD4 < 200 células/micro litro o < 14 % de todos los linfocitos
    - ALT o AST > 10 x el límite superior de la normalidad (LSN) detectado en la selección
    - Antecedentes de linfoma anaplásico de células grandes o linfoma de células del manto
    - Antecedentes de cáncer en los 5 años anteriores a menos que se haya tratado adecuadamente y se considere curado o sin remisión según el criterio del investigador
    -Signos clínicos de enfermedad cardiovascular activa o inestable (p. ej., isquemia miocárdica aguda o insuficiencia cardíaca descompensada) según la evaluación del investigador, ECG, evaluación de laboratorio, o datos ecocardiográficos
    - Antecedentes de reacciones alérgicas, anafilácticas o anafilactoides moderadas o intensas o de hipersensibilidad a cualquiera de los componentes del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. Clinical status assessed using a 7-category ordinal scale at Day 28
    1. Estado clínico evaluado mediante una escala ordinal de 7 categorías el día 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Day 28
    1. En el día 28
    E.5.2Secondary end point(s)
    1. Time to clinical improvement, defined as a National Early Warning Score 2 (NEWS2) of <= 2 maintained for 24 hours
    2. Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
    3. Incidence of mechanical ventilation
    4. Ventilator-free days to Day 28
    5. Incidence of ICU stay
    6. Duration of ICU stay
    7. Time to clinical failure
    8. Mortality rate at Days 7, 14, 21, 28, and 60
    9. Time to hospital discharge or “ready for discharge”
    10. Duration of supplemental oxygen
    11. Duration of hypoxemia (<= 93% on room air)
    12. Proportion of patients alive and free of respiratory failure at Day 28
    13. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
    14. Change from baseline in targeted vital signs, targeted clinical laboratory test results, and targeted ECG parameters
    15. Serum concentration of MSTT1041A at specified timepoints
    16. Serum concentration of UTTR1147A at specified timepoints
    17. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
    1. Tiempo hasta la mejoría clínica (THMC), definido como una puntuación en la Escala pronóstica de gravedad nacional (NEWS2) 2 mantenida durante 24 horas.
    2. Tiempo hasta la mejoría de al menos 2 categorías con respecto al momento basal en una escala ordinal de 7 categorías del estado clínico
    3. Incidencia de ventilación mecánica
    4. Días sin respirador hasta el día 28
    5. Incidencia de estancia en la UCI
    6. Duración de la estancia en la UCI
    7. Tiempo hasta el fracaso clínico
    8. Tasa de mortalidad los días 7, 14, 21, 28 y 60
    9. Tiempo hasta el alta hospitalaria o “listo para el alta”
    10. Duración de la oxigenoterapia
    11. Duración de la hipoxemia (93 % con aire ambiente)
    12. Proporción de pacientes vivos y sin insuficiencia respiratoria el día 28
    13. Incidencia e intensidad de los acontecimientos adversos, con determinación de la intensidad conforme a los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, versión 5.0
    14. Variación con respecto al momento basal de las constantes vitales de interés, los resultados analíticos de interés y los parámetros ECG de interés.
    15. Concentración sérica de MSTT1041A en momentos especificados
    16. Concentración sérica de UTTR1147A en momentos especificados
    17. Prevalencia de anticuerpos contra el fármaco (ACF) en el momento basal e incidencia de ACFdurante el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3 Up to Day 60
    4. Up to Day 28
    5-7. Up to Day 60
    8. At Days 7, 14, 21, 28, and 60
    9-11. Up to Day 60
    12. At Day 28
    13. Up to Day 60
    14. From baseline to Day 60
    15-16. Day 1-3, 7, 15, 21, 28, 60 or at early discontinuation visit
    17. Day 1, 15, 28, 60 or at early discontinuation visit
    1-3 Hasta el día 60
    4. Hasta el día 28
    5-7. Hasta el día 60
    8. En los días 7, 14, 21, 28 y 60
    9-11. Hasta el día 60
    12. En el día 28
    13. Hasta el día 60
    14. Desde la línea de base hasta el día 60
    15-16. Día 1-3, 7, 15, 21, 28, 60 o en la visita de interrupción temprana
    17. Día 1, 15, 28, 60 o en la visita de interrupción temprana
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, predictive biomarkers, prognostic biomarkers, PD biomarkers
    Inmunogenicidad, biomarcadores predictivos, biomarcadores pronósticos y biomarcadores FD
    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 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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    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
    Mexico
    Spain
    United States
    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
    The end of this study is defined as the date when the last patient, last visit, occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    El final del estudio se define como la fecha en que tenga lugar la última visita del último paciente o la fecha en que se reciban los últimos datos necesarios para el análisis estadístico o el seguimiento de seguridad del último paciente, lo que suceda más tarde.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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
    Patients who are on a ventilator or who have altered mental status will not be able to give consent.
    Los pacientes que están en un respirador o que tienen un estado mental alterado no podrán dar su consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 300
    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)
    Currently, the Sponsor (Genentech, a member of the Roche Group) does not have any plans to provide Genentech IMPs (MSTT1041A or UTTR1147A) or any other study treatments to patients who have completed the study.
    Actualmente, el promotor (Genentech, miembro del Grupo Roche) no tiene planes de proporcionar Genentech IMPs (MSTT1041A o UTTR1147A) o cualquier otro tratamiento del estudio a los pacientes que han completado el 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 Decision2020-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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