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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2020-001531-27
    Sponsor's Protocol Code Number:SARICOR
    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:2020-04-20
    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 number2020-001531-27
    A.3Full title of the trial
    Clinical trial of Sarilumab in adults hospitalized with COVID-19 presenting cytokine release syndrome
    Ensayo clínico de Sarilumab en adultos hospitalizados con COVID-19 que presentan síndrome de liberación de citoquinas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of Sarilumab in adults hospitalized with COVID-19
    Ensayo clínico de Sarilumab en adultos hospitalizados con COVID-19
    A.4.1Sponsor's protocol code numberSARICOR
    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 SponsorFundación para la Investigación Biomédica de Córdoba
    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 supportConsejería de Salud y Familias - Junta de Andalucía
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica de Córdoba
    B.5.2Functional name of contact pointAntonio Luque
    B.5.3 Address:
    B.5.3.1Street AddressEdificio IMIBIC. Avenida Menéndez Pidal s/n
    B.5.3.2Town/ cityCórdoba
    B.5.3.3Post code14004
    B.5.3.4CountrySpain
    B.5.4Telephone number0034671596070
    B.5.5Fax number0034957736571
    B.5.6E-mailuicec@imibic.org
    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 Kevzara 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis groupe
    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 Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARILUMAB
    D.3.9.1CAS number 1189541-98-7
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 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 Kevzara 400mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis groupe
    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 Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARILUMAB
    D.3.9.1CAS number 1189541-98-7
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 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
    SARS-CoV-2 infection causing respiratory disease and cytokine release syndrome
    Infección por SARS-CoV-2 que causa enfermedad respiratoria y síndrome de liberación de citocinas
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection causing respiratory disease
    Infección por coronavirus que causa enfermedad 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Decrease cases of ARDS in adults requiring HFNO or either non-invasive or invasive mechanical ventilation
    Disminuir los casos de síndrome del distress respiratorio del adulto que requieren oxigenación nasal de alto flujo (ONAF) o ventilación mecánica tanto no invasiva como invasiva
    E.2.2Secondary objectives of the trial
    To reduce crude mortality at 28 days
    To reduce the time (in days) to clinical improvement
    To reduce the time (in days) until improvement in oxygenation for at least 48 hours
    To reduce the proportion of patients who require invasive mechanical ventilation
    To study the effect of the drug on the negativization of the PCR to COVID-19
    To study the effect of the drug on the profile of cytokines
    To study the safety of the experimental drug
    Reducir la mortalidad cruda a los 28 días
    Reducir el tiempo (en días) hasta la mejoría clínica
    Reducir el tiempo (en días) hasta la mejoría en oxigenación durante al menos 48 horas
    Reducir la proporción de pacientes que precisan ventilación mecánica invasiva
    Estudiar el efecto del fármaco sobre la negativización de la PCR a COVID-19
    Estudiar el efecto del fármaco sobre el perfil de citoquinas
    Estudiar la seguridad del fármaco experimental
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years and <75 years
    2. Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
    3. Interstitial pneumonia confirmed by chest radiography or CT
    4. IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
    5. Negative pregnancy test in women of childbearing age
    6. Signature of informed consent
    1. Edad ≥ 18 años y < 75 años
    2. Ingreso por cuadro respiratorio confirmado a COVID-19 en base a una PCR positiva en una muestra del tracto respiratorio en el laboratorio local en ausencia de síndrome de distress respiratorio que precise ONAF o ventilación mecánica
    3. Neumonía intersticial confirmada por radiografía o TAC de tórax
    4. Niveles de IL-6 > 40 pg/ml. En su ausencia puede incluirse Dímero D (DD) > 1500 ó > 1000 si se documenta incrementos progresivos
    5. En mujeres en edad fértil, test de embarazo negativo
    6. Firma de consentimiento informado
    E.4Principal exclusion criteria
    1. SOFA score> 6 points
    2. Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
    3. Neutrophil count <2 x 103 / μL
    4. Platelet count <100 x 103 / μL
    5. ALT or AST levels> 5 times the upper limit of normal
    6. Severe renal failure (CrCr <30 ml / min)
    7. Active bacterial infectious process
    8. Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
    9. History of intestinal ulcer or diverticulitis
    10. History of hypersensitivity reactions to Sarilumab or its excipients
    11. Treatment with TNF antagonists
    13. Previous treatment with anti-IL6 in the previous 30 days
    14. Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
    15. Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
    16. Patients on immunosuppressive treatment for any cause
    17. HIV-infected patients with CD4 <200 / mm3
    18. Past or current history of autoimmune disease or systemic inflammatory disease
    19. Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
    20. Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
    21. Pregnancy
    22. Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
    1. SOFA score > 6 puntos
    2. Paciente que a criterio del investigador no sea subsidiario de ventilación mecánica invasiva
    3. Recuento de neutrófilos < 2 x 103/μL
    4. Recuento de plaquetas < 100 x 103/μL
    5. Niveles de ALT o AST > 5 veces el límite superior de la normalidad
    6. Insuficiencia renal grave (ClCr < 30 ml/min)
    7. Proceso infeccioso bacteriano activo
    8. Tuberculosis activa, historia de no completar un tratamiento frente a la tuberculosis, sospecha de tuberculosis extrapulmonar
    9. Antecedentes de úlcera intestinal o diverticulitis
    10. Antecedentes de reacciones de hipersensibilidad a Sarilumab o a sus excipientes
    11. Tratamiento con antagonistas de TNF
    13. Tratamiento previo con anti-IL6 en los 30 días previos
    14. Tratamiento previo de forma crónica con corticoides en dosis mayores a 0,5 mg/kg/día de prednisona o equivalente. Sí son aceptables los corticoides inhalados y tópicos
    15. Tratamiento concomitante con inmunomoduladores, entre los que se encuentran Vitamina D o estatinas. Sí son aceptables los macrólidos como la azitromicina
    16. Pacientes en tratamiento inmunosupresor por cualquier causa
    17. Pacientes infectados por VIH con CD4 < 200/mm3
    18. Historia pasada o actual de enfermedad autoinmune o enfermedad inflamatoria sistémica
    19. Pacientes que han recibido o se prevea terapia con anticuerpos inmunomoduladores, incluidas inmunoglobulinas
    20. Participación en cualquier ensayo clínico que evalué cualquier producto en investigación en los 3 últimos meses o inferior a 5 vidas medias del producto en investigación
    21. Embarazo
    22. Cualquier otra condición que a criterio clínico impidiera la adherencia al protocolo del paciente
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients requiring or time (in days) until required:
    - High flow nasal oxygenation (HFNO)
    - Non-invasive mechanical ventilation type BiPAP
    - Non-invasive mechanical ventilation type CPAP
    - Invasive mechanical ventilation
    Proporción de pacientes que requieren o tiempo (en días) hasta que se requiera:
    - Oxigenación nasal del alto flujo (ONAF)
    - Ventilación mecánica no invasiva tipo BiPAP
    - Ventilación mecánica no invasiva tipo CPAP
    - Ventilación mecánica invasiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 28 or when the subject is discharged (whichever occurs first)
    En el día 28 o cuando el sujeto es dado de alta (lo que ocurra primero)
    E.5.2Secondary end point(s)
    a. Crude mortality at 28 days

    b. Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories:
    1 - Not hospitalized with normal activity
    2 - Not hospitalized but unable to have normal activity
    3 - Hospitalized, without requiring oxygen supplementation
    4 - Hospitalized, requiring oxygen supplementation
    5 - Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both
    6 - Hospitalized requiring ECMO, invasive mechanical ventilation or both
    7 - Death

    c. Time (in days) until improvement in oxygenation for at least 48 hours:
    - Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD
    - Time to absence of oxygen requirement to maintain saturation in ambient air ≥ 93%
    - Number of days in need of supplemental oxygen

    d. Proportion of patients requiring invasive mechanical ventilation

    e. Proportion of patients having negative COVID-19 CRP at each visit

    f. Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF and PAI-1

    g. Incidence of adverse events related to medication and its administration
    h. Incidence in the appearance of serious bacterial, fungal or opportunistic infections
    i. Incidence of perforation of the gastrointestinal tract
    j. Leukocyte and neutrophil count mean
    k. Mean hemoglobin levels
    l. Platelet count mean
    m. Average levels of creatinemia
    n. Average bilirubin levels
    o. ALT and AST average levels
    a. Mortalidad cruda a los 28 días

    b. Tiempo hasta la mejoría clínica: se define como cambio medio o tiempo en días desde la aleatorización a cualquiera de los siguientes criterios: (i) mejoría de dos puntos en la escala ordinal de 7 puntos de gravedad o, (ii) alta del hospital con vida. Se utiliza el criterio que se alcance antes. La escala de 7 puntos de gravedad incluye las siguientes categorías:
    1 - No hospitalizado con actividad normal
    2 - No hospitalizado pero incapaz de tener una actividad normal
    3 - Hospitalizado, sin requerir suplemento de oxígeno
    4 - Hospitalizado, requiriendo suplemento de oxígeno
    5 - Hospitalizado, requiriendo ONAF, ventilación mecánica no invasiva o ambas
    6 - Hospitalizado requiriendo ECMO, ventilación mecánica invasiva o ambas
    7 - Muerte

    c. Tiempo (en días) hasta la mejoría en oxigenación durante al menos 48 horas:
    - Tiempo hasta constatar un incremento en la relación SpO2/FiO2 con respecto a la peor SpO2 / FiO2 previo al tratamiento con Sarilumab y estratificado según niveles de IL-6 o DD
    - Tiempo hasta la ausencia de necesidad de oxígeno para mantener una saturación a aire ambiente ≥ 93%
    - Número de días con necesidad de oxigeno suplementario

    d. Proporción de pacientes que precisan ventilación mecánica invasiva

    e. Proporción de pacientes que tienen PCR a COVID-19 negativa en cada visita

    f. Media de los niveles de citoquinas séricas: el panel de citoquinas a cuantificar; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF y PAI-1

    g. Incidencia de eventos adversos relacionados con la medicación y su administración
    h. Incidencia en la aparición de infecciones graves bacterianas, fúngicas u oportunistas
    i. Incidencia de perforación del tracto gastrointestinal
    j. Media de recuento de leucocitos y neutrófilos
    k. Media de niveles de hemoglobina
    l. Media de recuento de plaquetas
    m. Niveles medios de creatinemia
    n. Niveles medios de bilirrubina
    o. Niveles medios de ALT y AST
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 28 or when the subject is discharged (whichever occurs first)
    En el día 28 o cuando el sujeto es dado de alta (lo que ocurra primero)
    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 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
    Mejor terapia disponible
    Best available therapy
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    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 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
    Last visit of the last subject undergoing the trial
    Última visita del último sujeto 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 days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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 Decision2020-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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