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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2020-000936-23
    Sponsor's Protocol Code Number:C20-15
    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:2021-07-20
    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 number2020-000936-23
    A.3Full title of the trial
    Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults
    Ensayo multicéntrico, adaptativo y aleatorizado de la seguridad y eficacia de los tratamientos de COVID-19 en adultos hospitalizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of treatments of COVID-19 in hospitalized adults (Discovery)
    Seguridad y eficacia de los tratamientos de COVID-19 en adultos hospitalizados (Discovery)
    A.3.2Name or abbreviated title of the trial where available
    Discovery
    A.4.1Sponsor's protocol code numberC20-15
    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 SponsorINSERM
    B.1.3.4CountryFrance
    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 supportAstraZeneca
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportEuropean Commission 101015736
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSERM
    B.5.2Functional name of contact pointChristelle DELMAS
    B.5.3 Address:
    B.5.3.1Street Address8 rue de la Croix Jarry
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number33182 53 33 68
    B.5.6E-mailchristelle.delmas@inserm.fr
    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 nameAZD1061
    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 INNCilgavimab
    D.3.9.1CAS number 2420563-99-9
    D.3.9.4EV Substance CodeSUB218186
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 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 nameAZD8895
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNTixagevimab
    D.3.9.1CAS number 946832-34-4
    D.3.9.4EV Substance CodeSUB218187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    COVID-19 infection
    Infección COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID 19
    COVID 19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    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
    The overall objective of the study is to evaluate the clinical efficacy and safety of investigational therapeutics relative to the placebo arm among hospitalized adult patients who have COVID-19.
    • The primary endpoint is subject clinical status (on a 7-point ordinal scale) at Day 15
    El objetivo general del estudio es evaluar la eficacia clínica y la seguridad de las terapias en investigación en relación con el grupo de placebo entre los pacientes adultos hospitalizados que tienen COVID-19.
    • El criterio de valoración principal es el estado clínico del sujeto (en una escala ordinal de 7 puntos) en el día 15
    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of the investigational product on sustained recovery from index COVID-19 infection

    Evaluate clinical efficacy of investigational therapeutics as compared to the control arm assessed by:
    Ordinal scale : Subject clinical status on an ordinal scale on D29, 90, 180 and 365
    National Early Warning Score 2
    • Change from baseline to D3, 8, 15 and 29 in NEWS-2
    Oxygenation
    • Oxygenation-free days to D29, Incidence and duration of new oxygen use, non-invasive ventilation or high flow oxygen devices to D29
    Mechanical Ventilation
    • Ventilator-free days to D29, Incidence and duration of invasive mechanical ventilation use to D29, Need for mechanical ventilation or death by D15
    Hospitalization
    • Time to hospital discharge from randomization
    Mortality
    • In-hospital mortality, and mortality at D28, D90, D180, D365, D456
    Long term health status
    Evaluate the safety of different investigational therapeutics through 456 days as compared to the placebo arm
    Evaluar eficacia sobre recuperación sostenida de la infección índice COVID-19
    Evaluar eficacia clínica en comparación con grupo de control evaluado por:
    Escala ordinal: estado clínico del sujeto en una escala ordinal en D29, 90, 180 y 365
    Puntuación nacional de alerta temprana 2
    • Cambio de la línea de base a D3, 8, 15 y 29 en NOTICIAS-2
    Oxigenación
    • Días sin oxigenación hasta D29, Incidencia y duración del nuevo uso de oxígeno, ventilación no invasiva o dispositivos de alto flujo de oxígeno hasta D29
    Ventilacion mecanica
    • Días sin ventilador hasta D29, incidencia y duración uso de ventilación mecánica invasiva hasta D29, necesidad de ventilación mecánica o muerte para D15
    Hospitalización
    • Tiempo hasta alta hospitalaria de la aleatorización
    Mortalidad
    • Mortalidad hospitalaria y mortalidad en D28, D90, D180, D365, D456
    Estado salud a largo plazo
    Evaluar seguridad de diferentes terapias en investigación durante 456 días en comparación con el grupo de placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria:
    1. Adult ≥18 years of age at the time of enrolment
    2. Hospitalized patients with any of the following criteria:
    a. the presence of pulmonary rales/crackles on clinical exam OR
    b. SpO2 ≤ 94% on room air OR
    c. requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation
    3. A time between onset of symptoms and randomization of less than 9 days
    4. A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days preceding randomization
    5. The result of a rapid antigen test performed on a NP swab within the 6 hours preceding randomization
    6. Contraceptive use by men or women.
    a. Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue for 90 days following administration of IMP.
    b. Female participants: Women of child-bearing potential must agree to use contraception for 365 days following administration of IMP. Acceptable birth control methods are listed in section 8.5.
    Para ser elegible para participar en este estudio, un paciente debe cumplir con todos los siguientes criterios de inclusión:
    1. Adulto ≥18 años de edad en el momento de la inscripción
    2. Pacientes hospitalizados con alguno de los siguientes criterios:
    una. la presencia de estertores / crepitantes pulmonares en el examen clínico O
    B. SpO2 ≤ 94% en aire ambiente O
    C. requisito de oxígeno suplementario, incluidos dispositivos de oxígeno de alto flujo o ventilación no invasiva
    3. Un tiempo entre la aparición de los síntomas y la aleatorización de menos de 9 días
    4. Una PCR de SARS-CoV-2 positiva realizada en un hisopo NP dentro de los 5 días anteriores a la aleatorización
    5. El resultado de una prueba rápida de antígenos realizada en un hisopo NP dentro de las 6 horas anteriores a la aleatorización.
    6. Uso de anticonceptivos por hombres o mujeres.
    una. Participantes masculinos: No se requiere anticoncepción para los participantes masculinos; sin embargo, para evitar la transferencia de líquidos, todos los participantes masculinos deben usar un condón desde el día 1 y aceptar continuar durante los 90 días posteriores a la administración de IMP.
    B. Participantes femeninas: Las mujeres en edad fértil deben aceptar el uso de métodos anticonceptivos durante los 365 días posteriores a la administración de IMP. Los métodos anticonceptivos aceptables se enumeran en la sección 8.5.
    E.4Principal exclusion criteria
    An individual who meets any of the following criteria will be excluded from participation in this study:
    1. Refusal to participate expressed by patient or legally authorized representative
    2. Need for invasive mechanical ventilation and/or ECMO at the time of enrolment
    3. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
    4. Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance dialysis
    5. Pregnancy or breast-feeding
    6. Anticipated transfer to another hospital, which is not a study site within 72 hours following randomization
    7. Known history of allergy or reaction to any component of the study drug formulation.
    8. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies.
    9. Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19 or expected receipt in the 30 days following hospital discharge, according to current recommendation in each country.
    10. Any medical condition which, in the judgment of the investigator, could interfere with the interpretation of the trial results or that preludes to protocol adherence.
    Una persona que cumpla con cualquiera de los siguientes criterios será excluida de la participación en este estudio:
    1. Negativa a participar expresada por el paciente o representante legalmente autorizado
    2. Necesidad de ventilación mecánica invasiva y / o ECMO en el momento de la inscripción
    3. Niveles espontáneos de ALT / AST en sangre> 5 veces el límite superior de lo normal
    4. Tasa de filtración glomerular (TFG) <15 ml / min o que requiera diálisis de mantenimiento
    5. Embarazo o lactancia
    6. Transferencia anticipada a otro hospital, que no es un centro de estudio dentro de las 72 horas posteriores a la aleatorización
    7. Historial conocido de alergia o reacción a cualquier componente de la formulación del fármaco del estudio.
    8. Hipersensibilidad previa, reacción relacionada con la infusión o reacción adversa grave después de la administración de anticuerpos monoclonales o policlonales.
    9. Cualquier recepción previa de vacuna en investigación o autorizada u otro mAb / biológico indicado para la prevención de la infección por SARS-CoV-2 o COVID-19 o recepción prevista en los 30 días posteriores al alta hospitalaria, de acuerdo con las recomendaciones vigentes en cada país.
    10. Cualquier condición médica que, a juicio del investigador, pudiera interferir con la interpretación de los resultados del ensayo o que preludio al cumplimiento del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical status of subject on Day 15 (on a 7-point ordinal scale):
    1. Not hospitalized, no limitations on activities.
    2. Not hospitalized, limitation on activities.
    3. Hospitalized, not requiring supplemental oxygen.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
    6. Hospitalized, on invasive mechanical ventilation or ECMO.
    7. Death.
    Estado clínico del sujeto el día 15 (en una escala ordinal de 7 puntos):
    1. No hospitalizado, sin limitaciones de actividades.
    2. No hospitalizado, limitación de actividades.
    3. Hospitalizado, no requiriendo oxígeno suplementario.
    4. Hospitalizado, requiriendo oxígeno suplementario.
    5. Hospitalizados, con ventilación no invasiva o dispositivos de oxígeno de alto flujo.
    6. Hospitalizado, con ventilación mecánica invasiva o ECMO.
    7. Muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Día 15
    E.5.2Secondary end point(s)
    Time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
    For efficacy assessment
    • Status on an ordinal scale assessed at Day 29, 90, 180 and 365
    • NEWS-2 at baseline (Day 1 pre-treatment), at Days 3 and 8, 15 (if patient is still hospitalized), and at Days 29 at baseline and at Days 3, 8, 15 (while hospitalized) and at Day 29
    • Duration of supplemental oxygen (if applicable)
    • Duration of mechanical ventilation (if applicable)
    • Date of discharge from hospital
    • Date and cause of death (if applicable)
    • Mechanical ventilation or death between baseline and Day 15
    • Occurrence of new hospitalization between discharge from index hospitalization and Days 90, 180 and 365
    • Occurrence of confirmed re-infection with SARS-CoV-2 between discharge and Days 90, 180 and 365
    For safety assessment
    • SAEs
    • Grade 3 and 4 adverse events
    • AEs of Special Interest
    Grade 1-2hypersensitivity-related and infusion related AEs until D29 visit
    • Discontinuation of investigational therapeutics (for any reason)
    Tiempo desde la aleatorización hasta la recuperación sostenida, definido como el alta de la hospitalización índice, seguido de estar vivo y en casa durante 14 días consecutivos antes del día 90.
    Para la evaluación de la eficacia
    • Estado en una escala ordinal evaluada en los días 29, 90, 180 y 365
    • NOTICIAS-2 al inicio (pretratamiento del día 1), en los días 3 y 8, 15 (si el paciente aún está hospitalizado), y en los días 29 al inicio del estudio y en los días 3, 8, 15 (mientras está hospitalizado) y el día 29
    • Duración del oxígeno suplementario (si corresponde)
    • Duración de la ventilación mecánica (si corresponde)
    • Fecha de alta del hospital
    • Fecha y causa de muerte (si corresponde)
    • Ventilación mecánica o muerte entre el inicio y el día 15
    • Ocurrencia de nueva hospitalización entre el alta de la hospitalización índice y los días 90, 180 y 365
    • Ocurrencia de reinfección confirmada con SARS-CoV-2 entre el alta y los días 90, 180 y 365
    Para evaluación de seguridad
    • SAE
    • Eventos adversos de grado 3 y 4
    • EA de especial interés
    EA de grado 1-2 relacionados con la hipersensibilidad y relacionados con la infusión hasta la visita D29
    • Interrupción de terapias en investigación (por cualquier motivo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 15, Day 29, Day 90, Day 180, Day 365, Day 456
    Día 15, Día 29, Día 90, Día 180, Día 365, Día 456
    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) 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 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) 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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Turkey
    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
    Completion of the last 456 day data collection
    Finalización de la recopilación de datos de los últimos 456 días
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 640
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 640
    F.4.2.2In the whole clinical trial 1240
    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)
    No post trial treatment as patient should be cured
    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 Decision2021-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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