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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2021-000605-24
    Sponsor's Protocol Code Number:ESPERANZA_COVID
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 number2021-000605-24
    A.3Full title of the trial
    Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID: E-SPERANZA COVID PROJECT
    Ensayo clínico aleatorizado doble ciego, controlado con placebo para evaluar la eficacia de montelukast en los síntomas respiratorios leves-moderados en pacientes con COVID persistente: PROYECTO E-SPERANZA COVID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy of montelukast in improving respiratory symptoms in patients with long COVID: E-SPERANZA COVID PROJECT
    Estudio para valorar la eficàcia del montelukast en la mejoría de los síntomas respiratorios en pacientes con COVID persistente: PROYECTO E-SPERANZA COVID
    A.3.2Name or abbreviated title of the trial where available
    Montelukast in Mild-moderate Respiratory Symptoms in Patients with Long-COVID
    Montelukast en síntomas respiratorios leves-moderados en pacientes con COVID persistente
    A.4.1Sponsor's protocol code numberESPERANZA_COVID
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04695704
    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 SponsorIDIAP Jordi Gol
    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 supportUniversitat Autònoma de Barcelona (UAB)
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportIDIAP Jordi Gol
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIAP Jordi Gol
    B.5.2Functional name of contact pointUnitat d'Estudi del Medicament -UEM
    B.5.3 Address:
    B.5.3.1Street AddressGran Via Corts Catalanes, 587
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number34934824124
    B.5.5Fax number34934824174
    B.5.6E-mailagarcia@idiapjgol.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.2.5The 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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmontelukast
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a history of SAR-Cov-2 infection (PCR positive) with long Covid-19 and mild or moderate respiratory symptoms of more than 1 month and less than 4 months of evolution, attended in Primary Care.
    Pacientes con antecedentes de infección por SAR-Cov-2 (PCR positivo) con Covid-19 persistente y síntomas respiratorios leves o moderados de mas de 1 mes y menos de 4 meses de evolución, atendidos en Atención Primaria.
    E.1.1.1Medical condition in easily understood language
    Patients attended in Primary Care with persistent Covid in which mild or moderate respiratory symptoms last more than 1 month and less than 4 months.
    Pacientes atendidos en Atención Primaria con Covid persistente en los cuales los síntomas respiratorios leves o moderados duran mas de 1 mes y menos de 4 meses.
    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 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the efficacy of montelukast versus placebo to improve the quality of life associated with respiratory symptoms.
    El objetivo principal es evaluar la eficacia de montelukast frente a placebo para mejorar la calidad de vida asociada a los síntomas respiratorios.
    E.2.2Secondary objectives of the trial
    a)To evaluate the effect of Montelukast versus placebo on improving exercise capacity (‘1min sit-to-stand’ test).
    b)To evaluate the effect of Montelukast versus placebo on O2 desaturation ≥ 4% with effort.
    b) To evaluate post covid 19 functional status scale.
    c) To evaluate the effect of Montelukast versus placebo on the use of healthcare resources:
    - Number of visits to primary care.
    - Number of emergencies visits.
    - Number of hospital admissions.
    d) To assess the effect on mortality
    f) To assess the effect on medication side effects
    g) To evaluate the effect in the improvement of other symptoms: asthenia, headache, brain fog, ageusia, anosmia, and rhinitis.
    h) To evaluate the effect in reducing days of work sick leave
    i) Assess whether antinuclear antibodies are predictors of response to montelukast.
    j) Evaluate quality of life (CAT scale) of respiratory symptoms one month after finishing treatment
    a) Evaluar el efecto de montelukast frente a placebo en la mejora de la capacidad de ejercicio (prueba de "1 minuto sentado y de pie")
    b) Evaluar el efecto de montelukast frente a placebo sobre la desaturación de O2 ≥ 4% con esfuerzo
    c) Evaluar el efecto de montelukast frente a placebo sobre el grado de afectacion funcional post Covid
    d) Evaluar el efecto sobre el uso de recursos sanitarios:
    - Número de visitas a atención primaria
    - Número de visitas a urgencias
    - Número de ingresos hospitalarios
    d) Evaluar el efecto sobre la mortalidad
    e) Evaluar los efectos secundarios de la medicación
    f) Evaluar el efecto en la mejora de otros síntomas: astenia, cefalea, confusión mental, ageusia, anosmia y rinitis
    g) Evaluar el efecto en la reducción de días de baja laboral por enfermedad
    h) Evaluar si los anticuerpos antinucleares son predictores de respuesta a montelukast.
    i) Evaluar calidad de vida (CAT scale) de la sintomatología respiratoria al mes de finalizar el tratamiento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) Title: Esperanza-Pneumology. Date 15/02/2021. version 1.0 Objectives: To identify the mechanisms involved in persistent dyspnoea, the persistent respiratory symptoms (dyspnoea with/without cough)
    - To assess small airway bronchial obstruction.
    - To evaluate carbon monoxide diffusion through the alveolar-capillary barrier (DLCO)
    - To evaluate the 6 minute walking test (6MWT).
    2) Title: Esperanza-Immunology. Date 15/02/2021. version 1.0 Objectives:To characterize the immune response in long Covid-19
    - To assess the presence of different Interferon neutralizing antibodies
    - To study different immune variables (lymphoid subpopulations, immunoglobulins and cytokines) and to identify activated immune response pathways
    3) Title: Esperanza-Microbiology. Date 15/02/2021. version 1.0 Objectives:To microbiologically characterize long Covid-19
    - To describe the gut microbiota alterations among long Covid-19 patients, compared with mild COVID patients.
    - To investigate whether the gut microbiota can be restored after specific treatment (Montelukast).
    - To analyse the presence of SARS-CoV-2 in stool samples
    1) Título: Esperanza-Neumología. Fecha 15/02/2021. versión 1.0 Objetivos: Identificar los mecanismos implicados en la disnea persistente, los síntomas respiratorios persistentes (disnea con / sin tos)
    - Evaluar la obstrucción bronquial de las vías respiratorias pequeñas.
    - Evaluar la difusión del monóxido de carbono a través de la barrera alveolar-capilar (DLCO)
    - Evaluar la prueba de marcha de 6 minutos (6MWT).
    2) Título: Esperanza-Inmunología. Fecha 15/02/2021. versión 1.0 Objetivos: Caracterizar la respuesta inmune en Covid-19 largo
    - Evaluar la presencia de diferentes anticuerpos neutralizantes de interferón
    - Estudiar diferentes variables inmunes (subpoblaciones linfoides, inmunoglobulinas y citocinas) e identificar vías de respuesta inmunitaria activadas.
    3) Título: Esperanza-Microbiology. Fecha 15/02/2021. versión 1.0 Objetivos: Caracterizar microbiológicamente Covid-19 largo
    - Describir las alteraciones de la microbiota intestinal entre pacientes prolongados con Covid-19, en comparación con pacientes con COVID leve.
    - Investigar si la microbiota intestinal se puede restaurar después de un tratamiento específico (Montelukast).
    - Analizar la presencia de SARS-CoV-2 en muestras de heces
    E.3Principal inclusion criteria
    Patients aged 18 to 80 years with SARS-CoV-2 infection (positive PCR) attended in Primary Care.

    Persistent respiratory symptoms (more than 1 and <4 months of evolution)

    Mild-moderate dyspnea: score at baseline according to the modified Medical Research Council (mMRC) scale from 0 to 3

    The patient must be competent to complement the follow-up evaluations.

    The patient agrees to participate in the study and take the assigned medication during the 4 weeks.

    Sign the informed consent
    Pacientes de 18 a 80 años con infección por SARS-CoV-2 (PCR positiva) atendidos en Atención Primaria.

    Síntomas respiratorios persistentes (más de 1 y <4 meses de evolución)

    Disnea leve-moderada: puntuación al inicio del estudio según la escala modificada del Medical Research Council (mMRC) de 0 a 3

    El paciente debe ser competente para complementar las evaluaciones de seguimiento.

    El paciente acepta participar en el estudio y tomar la medicación asignada durante las 4 semanas.

    Firmar el consentimiento informado
    E.4Principal exclusion criteria
    Severity criteria: fever> 38ºC, or O2 saturation <93%.

    Patients with SARS-Cov-2 pneumonia in the acute / subacute phase.

    Patients who have required hospital admission for SARS-Cov-2.

    Chronic Obstructive Pulmonary Disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obstructive sleep apnea syndrome (OSAS), chronic respiratory failure from any cause, home oxygen therapy.

    Use of montelukast or zafirlukast ≤ 30 days prior to inclusion

    Use of gemfibrocil.

    Hypersensitivity to montelukast, lactose intolerance or intolerance to any of the excipients of the trial treatment.

    Active malignancy, current or recent chemotherapy treatment (<6 months).

    Medical history of infection by the Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.

    Pregnancy or planning of being pregnant.

    Breastfeeding mother.

    Any other condition for which, in the opinion of the principal investigator, it is considered that the subject will not be able to perform the clinical trial procedures.
    Criterios de gravedad: fiebre> 38ºC o saturación de O2 <93%.

    Pacientes con neumonía por SARS-Cov-2 en fase aguda / subaguda.

    Pacientes que han requerido ingreso hospitalario por SARS-Cov-2.

    Enfermedad Pulmonar Obstructiva Crónica (EPOC), asma, bronquiectasias, fibrosis pulmonar, síndrome de apnea obstructiva del sueño (SAOS), insuficiencia respiratoria crónica por cualquier causa, oxigenoterapia domiciliaria.

    Uso de montelukast o zafirlukast ≤ 30 días antes de la inclusión

    Uso de gemfibrocilo.

    Hipersensibilidad a montelukast, intolerancia a la lactosa o a cualquiera de los excipientes del tratamiento de ensayo.

    Malignidad activa, tratamiento de quimioterapia actual o reciente (<6 meses).

    Antecedentes médicos de infección por el virus de la inmunodeficiencia humana (VIH) o cualquier estado inmunodeprimido grave.

    Embarazo o planificación de embarazado.

    Madre que amamanta.

    Cualquier otra condición por la que, a juicio del investigador principal, se considere que el sujeto no podrá realizar los procedimientos del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Quality of life of respiratory symptoms according to the COP Assessment Test Scale (CAT) 4 weeks after starting treatment. The CAT scale is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.
    Calidad de vida de la sintomatología respiratoria según la escala COP Assessment Test Scale (CAT) a las 4 semanas de iniciar el tratamiento. Se trata de una escala autoadministrada validada para cuantificar y monitorizar el impacto de la EPOC en el bienestar y la vida diaria
    E.5.1.1Timepoint(s) of evaluation of this end point
    [ Time Frame: 7, 14, 21, and 28 days ]
    [Periodo de tiempo: 7, 14, 21, y 28 días]
    E.5.2Secondary end point(s)
    1. Effort capacity according to the 1min sit-to-stand test: number of repetitions performed.
    2. O2 desaturation ≥ 4% with effort (1min sit-to-stand test).
    3. Asthenia according to a 10-point Likert scale.
    4. Headache according to a 10-point Likert scale.
    5. Ageusia according to a 10-point Likert scale.
    6. Anosmia according to a 10-point Likert scale.
    7. Number of consultations related to the COVID-19 clinic in primary care (face-to-face and non-face-to-face, public and / or private health services) according to questioning and review of the clinical history during the study period.
    8. Number of visits to the emergency room in primary care related to the COVID-19 clinic (public and / or private health services) according to questioning and review of the medical history during the study period.
    9. Number of visits to hospital emergencies related to the COVID-19 clinic (public and / or private health services) according to questioning and review of clinical history during the study period
    10. Number of hospital admissions related to the COVID-19 clinic during the study period.
    11. Mortality
    12. Days of temporary incapacity for work for reasons related to COVID-19 during the study period.
    13. Serious adverse events.
    14. Non-serious adverse events related to study medication.
    15. Adherence to medication.
    16. Baseline antinuclear antibody value.
    17. Quality of life of respiratory symptoms according to the CAT scale one month after finishing treatment.
    1. Capacidad al esfuerzo según el 1min sit-to-stand test: número de repeticiones realizadas.
    2. Desaturación de O2 ≥ 4% con el esfuerzo (1min sit-to-stand test).
    3. Astenia según escala de Likert de 10 puntos.
    4. Cefalea según escala de Likert de 10 puntos.
    5. Ageusia según escala de Likert de 10 puntos.
    6. Anosmia según escala de Likert de 10 puntos.
    7. Número de consultas relacionadas con clínica COVID-19 en atención primaria (presenciales y no presenciales, servicios sanitarios públicos y/o privados) según interrogatorio y revisión de historia clínica durante el periodo de estudio.
    8. Número de visitas a urgencias en atención primaria relacionadas con clínica COVID-19 (servicios sanitarios públicos y/o privados) según interrogatorio y revisión de historia clínica durante el periodo de estudio.
    9. Número de visitas a urgencias hospitalarias relacionadas con clínica COVID-19 (servicios sanitarios públicos y/o privados) según interrogatorio y revisión de historia clínica durante el periodo de estudio
    10. Número de ingresos hospitalarios relacionados con clínica COVID-19 durante el periodo de estudio.
    11. Mortalidad
    12. Días de incapacidad laboral transitoria por motivos relacionados con el COVID-19 durante el periodo de estudio.
    13. Acontecimientos adversos graves.
    14. Acontecimientos adversos no graves relacionados con la medicación de estudio.
    15. Adherencia a la medicación.
    16. Valor anticuerpos antinucleares basal.
    17. Calidad de vida de la sintomatología respiratoria según la escala CAT al mes de finalizar el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1min sit-to-stand test [Time Frame: 0, 14 and 28 days ]
    O2 desaturation [ 0, 14 and 28 days ]
    10-point Likert scale [ 0, 7, 14, 21, 28, and 54 days ]
    Number of visits to primary care [ 28 and 54 days ]
    Number of visits to the emergency room in both hostpital and primary care [ 28 and 54 days ]
    Number of hospital admissions. [ 28 and 54 days ]
    Days of sick leave [ 28 and 54 days ]
    All-cause mortality [ 7, 14, 21 and 28 and 54 days ]
    Medication side effects [ 7, 14, 21, 28 and 54 days ]
    Adherence to medication [ 7, 14, 21, 28 and 54 days ]
    Baseline antinuclear antibody value [ 0 days ]
    Quality of life of respiratory symptoms according to the CAT scale one month after finishing treatment. [ 54 days ]
    Capacidad al esfuerzo según el 1min sit-to-stand test [Periodo de tiempo: 0, 14 y 28 días]
    Desaturación de O2 [ 0, 14 y 28 días]
    Escala Likert de 10 puntos [ 0, 7, 14, 21, 28 y 54 días]
    Número de visitas a atención primaria [28 y 54 días]
    Número de visitas a urgencias tanto en el hospital como en la atención primaria [28 y 54 días]
    Número de ingresos hospitalarios. [ 28 y 54 días]
    Días de baja por enfermedad [28 y 54 días]
    Mortalidad por todas las causas [ 7, 14, 21, 28 y 54 días]
    Efectos secundarios de los medicamentos [ 7, 14, 21, 28 y 54 días]
    Adherencia a la medicación [ 7, 14, 21, 28 y 54 días]
    Valor inicial de anticuerpos antinucleares [ 0 días]
    Calidad de vida de los síntomas respiratorios según la escala CAT al mes de finalizar el tratamiento. [ 54 días]
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 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 concerned13
    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 del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state284
    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. Usual clinical practice follow up.
    Ninguna. Seguimiento por práctica clínica habitual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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