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    Summary
    EudraCT Number:2022-000736-37
    Sponsor's Protocol Code Number:1001
    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:2022-07-19
    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 number2022-000736-37
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19
    Ensayo de fase III aleatorizado, comparativo con placebo, doble ciego y multicéntrico para evaluar la eficacia y la seguridad de la trimodulina (BT588) en participantes adultos hospitalizados con COVID-19 moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19
    Ensayo de fase III aleatorizado, comparativo con placebo, doble ciego y multicéntrico para evaluar la eficacia y la seguridad de la trimodulina (BT588) en participantes adultos hospitalizados con COVID-19 moderada o grave
    A.3.2Name or abbreviated title of the trial where available
    TRICOVID
    A.4.1Sponsor's protocol code number1001
    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 SponsorBiotest AG
    B.1.3.4CountryGermany
    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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstrasse 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number34935952661
    B.5.6E-mailpatrick.langohr@biotest.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 nameTrimodulin
    D.3.2Product code BT588
    D.3.4Pharmaceutical form 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 INNTrimodulin (human IgM, IgA, IgG solution)
    D.3.9.3Other descriptive nameTrimodulin (human IgM, IgA, IgG solution)
    D.3.9.4EV Substance CodeSUB215556
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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 Yes
    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 placeboSolution for 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
    moderate or severe Coronavirus Disease 2019 (COVID-19)
    Enfermedad moderada o grave por Coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    moderate or severe Coronavirus Disease 2019 (COVID-19)
    Enfermedad moderada o grave por Coronavirus 2019 (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 23.0
    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 objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with moderate or severe COVID-19.
    Los principales objetivos del ensayo son evaluar la eficacia y la seguridad de la trimodulina como tratamiento complementario al tratamiento de referencia (TdR) en comparación con placebo más el TdR en participantes adultos hospitalizados con COVID-19 moderada o grave.
    E.2.2Secondary objectives of the trial
    Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.
    Otros objetivos son determinar las propiedades farmacocinéticas (FC) y farmacodinámicas (FD) de la trimodulina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject or legally acceptable/authorized representative (LAR) or informed verbal consent in case of pandemic restrictions, in compliance with all local legal requirements.
    2. Hospitalized, adult (≥ 18 years of age) subject (any gender).
    3. Laboratory-confirmed acute SARS-CoV-2 infection within 5 days prior to screening.
    4. Receiving oxygen supply via low-flow oxygen (LFO, by mask or nasal prongs) or on non-invasive ventilation (NIV) or high-flow oxygen (HFO) at start of treatment.
    5. Fulfilling at least one of the following clinical respiratory parameters within 24 hours prior to start of treatment:
    - SpO2 ≤ 94% (on room air, and without preceding chronic lung disease);
    - 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg under HFO or NIV;
    - Radiologic evidence of COVID-19 pneumonia.
    6. C-reactive protein ≥ 50 mg/L and ≤ 150 mg/L within 24 hours prior to start of treatment.
    7. D-dimer ≤ 3 mg/L and platelets ≥ 130 x109/L within 24 hours prior to start of treatment.
    8. Treatment with investigational medicinal product (IMP) has to be started within 7 days after first hospital-admission for COVID-19.
    9. Subject must receive SoC treatment for COVID-19 according to Section 6.9 in the protocol.
    1. Consentimiento informado por escrito por parte del participante o representante legal (RL) o consentimiento verbal informado en caso de restricciones pandémicas, de conformidad con todos los requisitos legales locales.
    2. Participante hospitalizado, adulto (≥18 años, de cualquier sexo).
    3. Infección aguda por SARS-CoV-2 con confirmación mediante análisis de laboratorio dentro de los 5 días previos a la selección.
    4. Recepción de suministro de oxígeno a través de oxigenoterapia de bajo flujo (OBF, por máscara o gafas nasales) o con ventilación no invasiva (VNI) u oxigenoterapia de alto flujo (OAF) al inicio del tratamiento.
    5. Cumplimiento de, al menos, uno de los siguientes parámetros clínicos respiratorios hasta 24 horas antes del inicio del tratamiento:
    • SpO2 ≤94 % (respirando aire ambiente y sin enfermedad pulmonar crónica previa);
    • 100 mm Hg <pO2 o FiO2 ≤300 mm Hg con OAF o VNI;
    • Indicios radiológicos de neumonía por COVID-19.
    6. Proteína C reactiva ≥50 mg/l y ≤150 mg/l hasta 24 horas antes del inicio del tratamiento.
    7. Dímero D ≤3 mg/l y plaquetas ≥130 x 109/l hasta 24 horas antes del inicio del tratamiento.
    8. El tratamiento con el producto en investigación (PEI) debe iniciarse dentro de los 7 días posteriores al primer ingreso hospitalario por COVID-19.
    9. El participante debe recibir el tratamiento TdR para la COVID-19 de acuerdo con la sección 6.9 del protocolo.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. Subject on invasive mechanical ventilation (IMV) and/or extracorporeal membrane oxygenation (ECMO) or predicted to be on IMV and/or ECMO at start of treatment.
    3. Subject with sustained improvement in any form of oxygen supply (e.g. change from IMV to NIV/HFO/LFO, or change from HFO to LFO) during the last 7 days or with predicted cessation of oxygen supply at start of treatment.
    4. Severe neutropenia (neutrophil count < 0.5 x109/L) assessed within 24 hours prior to start of treatment.
    5. Hemoglobin < 7g/dL assessed within 24 hours prior to start of treatment.
    6. Known hemolytic disease.
    7. Known thrombosis or acute thromboembolic events (TEEs) or known medical history of TEEs (e.g. cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within 3 months before entering the trial. Subjects particularly at risk for TEEs caused by other reasons than the current COVID-19 infection (e.g. history of thrombophilia).
    8. Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² assessed
    within 24 hours prior to start of treatment (details in Appendix 3: Estimated Glomerular Filtration Rate).
    9. Subject with end stage renal disease (ESRD), or known primary focal segmental glomerulosclerosis (FSGS).
    10. Known severe lung diseases interfering with COVID-19 therapy (e.g. COPD (GOLD stage III-IV / Group D), severe interstitial lung disease, cystic fibrosis, idiopathic pulmonary fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).
    11. Known decompensated heart failure (New York Heart Association class III–IV).
    12. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh C score ≥ 9 points), or hepatocellular carcinoma.
    13. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin.
    14. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.
    15. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months.
    16. Known human immunodeficiency virus infection.
    17. Life expectancy of less than 90 days, according to the Investigator’s clinical judgment, because of medical conditions neither related to COVID-19 nor to associated medical complications.
    18. Morbid obesity with high body mass index ≥ 40 kg/m², or malnutrition with low body mass index < 16 kg/m².
    19. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before entering the trial.
    20. Known treatment with exploratory selective immune suppressors (cytokine inhibitors, cytokine receptor inhibitors, kinase inhibitors) during the last 10 days before entering the trial.
    21. Known treatment with fluoroquinolone preparations, during the last 5 days before entering the trial.
    22. Known treatment with any type of interferon during the last 21 days before entering the trial.
    23. Known treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of acute COVID-19.
    24. Participation in another interventional clinical trial within 30 days before entering, or previous participation in this clinical trial.
    25. Employee or direct relative of an employee of the contract research organization, the trial site, or Biotest.
    1. Embarazadas o mujeres que amamanten.
    2. Participante con ventilación mecánica invasiva (VMI) u oxigenación por membrana extracorpórea (OMEC) o que se haya previsto que esté con VMI u OMEC al inicio del tratamiento.
    3. Participante en mejora constante con cualquier forma de suministro de oxígeno (p. ej., cambio de VMI a VNI, OAF u OBF, o cambio de OAF a OBF) durante los últimos 7 días o con interrupción prevista del suministro de oxígeno al inicio del tratamiento.
    4. Evaluación de neutropenia grave (recuento de neutrófilos <0,5 x 109/l) hasta 24 horas antes del inicio del tratamiento.
    5. Evaluación de hemoglobina <7 g/dl hasta 24 horas antes del inicio del tratamiento.
    6. Enfermedad hemolítica conocida.
    7. Trombosis conocida o eventos tromboembólicos agudos (ETE) o antecedentes médicos conocidos de ETE (p. ej., accidentes cerebrovasculares, ataque isquémico temporal, infarto de miocardio, embolia pulmonar y trombosis venosa profunda) hasta 3 meses antes del ingreso al ensayo. Participantes con riesgo especial de ETE por otros motivos distintos de la infección actual por la COVID-19 (p. ej., antecedentes de trombofilia).
    8. Participante con diálisis o con disfunción renal grave, tasa de filtración glomerular estimada (TFGe) <30 ml/min/1,73 m² evaluada hasta 24 horas antes del inicio del tratamiento (detalles en el Apéndice 3: Tasa de filtración glomerular estimada).
    9. Participante con insuficiencia renal terminal (IRT) o glomeruloesclerosis focal y segmentaria primaria (GEFS) conocida.
    10. Enfermedades pulmonares graves conocidas que interfieren con el tratamiento de la COVID-19 (p. ej., EPOC (etapas GOLD III-IV/grupo D), enfermedad pulmonar intersticial grave, fibrosis quística, fibrosis pulmonar idiopática, tuberculosis activa, bronquiectasias con infección crónica o cáncer de pulmón activo).
    11. Insuficiencia cardíaca descompensada conocida (clase III-IV de la New York Heart Association).
    12. Cirrosis hepática preexistente conocida, insuficiencia hepática grave (C ≥9 puntos según la escala de Child Pugh) o carcinoma hepatocelular.
    13. Intolerancia conocida a las proteínas de origen humano o reacciones alérgicas conocidas a los componentes de la trimodulina.
    14. Deficiencia selectiva y absoluta de inmunoglobulina A (IgA) con anticuerpos conocidos contra la IgA.
    15. Tratamiento conocido para neoplasias malignas de tórax, cabeza, cuello o hematológicas en los últimos 12 meses.
    16. Infección conocida por virus de la inmunodeficiencia humana.
    17. Esperanza de vida de menos de 90 días, según el criterio clínico del investigador, debido a afecciones médicas no relacionadas con la COVID-19 ni complicaciones médicas asociadas.
    18. Obesidad mórbida con índice de masa corporal alto ≥40 kg/m² o desnutrición con índice de masa corporal bajo <16 kg/m².
    19. Tratamiento conocido con preparados de inmunoglobulina polivalente, plasma o preparaciones de albúmina durante los últimos 21 días antes de ingresar al ensayo.
    20. Tratamiento conocido con inmunosupresores selectivos exploratorios (inhibidores de citocinas, inhibidores de receptores de citocinas, inhibidores de cinasas) durante los últimos 10 días antes de ingresar al ensayo.
    21. Tratamiento conocido con preparados de fluoroquinolonas durante los últimos 5 días antes de ingresar al ensayo.
    22. Tratamiento conocido con cualquier tipo de interferón durante los últimos 21 días antes de ingresar al ensayo.
    23. Tratamiento conocido con inmunosupresores distintos de los inmunosupresores recomendados por las orientaciones para el tratamiento de la COVID-19 aguda.
    24. Participación en otro ensayo clínico intervencionista hasta 30 días antes de ingresar, o antes de participar en este ensayo clínico.
    25. Empleado o pariente directo de un empleado de la organización de investigación clínica, el centro del ensayo o Biotest.
    E.5 End points
    E.5.1Primary end point(s)
    Composite primary endpoint: Deterioration / mortality rate
    Criterio de valoración principal compuesto:
    Tasa de empeoramiento/ mortalidad
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Clinical deterioration (increment of at least 1 category on the 9-category ordinal-scale from baseline) between day 6 and day 29
    - 28-day all-cause mortality between day 1 and day 29
    • Empeoramiento clínico (incremento de, al menos, 1 categoría en la escala ordinal de 9 categorías desde el valor inicial) entre el día 6 y el día 29
    • Mortalidad por cualquier causa a los 28 días entre el día 1 y el día 29
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - Clinical deterioration rate (day 6-29)
    - Clinical deterioration rate (day 1-29)
    - 28-days all-cause mortality rate on day 29
    - 90-days all-cause mortality rate on day 91
    - Time to recovery to score ≤ 2 until day 29
    - Proportion of subjects with score ≤ 2 on day 29
    - Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days
    - Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300 on days 7, 14, 21, 29
    - Days of IMV/ECMO until day 29
    - Proportion of subjects on IMV/ECMO until day 29
    - Days with oxygen supply until day 29
    - Proportion of subjects with oxygen supply on days 7, 14, 21, 29
    - Days in intensive care unit (ICU) until day 29
    - Proportion of subjects in ICU until day 29
    - Days of hospitalization until day 29

    Secondary safety endpoints:
    - Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial through day 29 [+3]
    - Number of all infusion-related TEAEs through day 29 [+3]
    - Number, severity, causality, and outcome of all serious adverse events (SAEs) through day 29 [+3]
    - Dose modifications (incl. reductions and changes in infusion rate)
    - Distribution and changes over time for safety, laboratory, vital signs parameters, and ECG

    Secondary PK endpoints:
    Changes from baseline, during and after treatment:
    - Serum concentration of IgM, IgA, and IgG

    Secondary PD endpoints:
    Changes from baseline, during and after treatment:
    - Factors and markers of coagulation
    - Markers of inflammation
    - Complement factors
    - Biomarkers
    - Anti-SARS-CoV-2 titers
    Criterios de valoración secundarios:
    • Tasa de empeoramiento clínico (día 6-29)
    • Tasa de empeoramiento clínico (día 1 al 29)
    • Tasa de mortalidad por cualquier causa durante 28 días en el día 29
    • Tasa de mortalidad por cualquier causa durante 90 días en el día 91
    • Tiempo de recuperación para alcanzar una puntuación de ≤2 hasta el día 29
    • Proporción de participantes con puntuación ≤2 el día 29
    • Proporción de participantes que mejoraron, no presentaron cambios y empeoraron o murieron en comparación con el valor inicial en varios días
    • Proporción de participantes con relación de pO2 y FiO2 <100, 100 a
    <200, 200 a <300 o ≥300 en los días 7, 14, 21, 29
    • Días de VMI u OMEC hasta el día 29
    • Proporción de participantes con VMI u OMEC hasta el día 29
    • Días con suministro de oxígeno hasta el día 29
    • Proporción de participantes con suministro de oxígeno los días 7, 14, 21, 29
    • Días en la unidad de cuidados intensivos (UCI) hasta el día 29
    • Proporción de participantes en UCI hasta el día 29
    • Días de hospitalización hasta el día 29
    Criterios de valoración secundarios:
    • Cantidad, intensidad, causalidad, resultado y gravedad de todos los eventos adversos (EA), EA emergentes del tratamiento (EAET), EA de especial interés (EAEI), EAET por la infusión, EAET que llevaron a la retirada definitiva del PEI y EAET que provocaron la suspensión del ensayo hasta el día 29 [+3]
    • Cantidad de todos los EAET relacionados con la infusión hasta el día 29 [+3]
    • Cantidad, intensidad, causalidad y resultado de todos los eventos adversos graves (EAG) hasta el día 29 [+3]
    • Modificaciones de dosis (lo que incluye las reducciones y cambios en la velocidad de la infusión)
    • Distribución y cambios en el tiempo para los parámetros de seguridad, laboratorio, signos vitales y ECG
    Criterios de valoración secundarios:
    Cambios desde el valor inicial, durante y después del tratamiento:
    • Concentración sérica de IgM, IgA e IgG
    Criterios de valoración secundarios:
    Cambios desde el valor inicial, durante y después del tratamiento:
    • Factores y marcadores de la coagulación
    • Marcadores de inflamación
    • Factores del complemento
    • Biomarcadores
    • Títulos contra el SARS-CoV-2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Included in E.5.2
    Incluido en E.5.2.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Brazil
    Chile
    Colombia
    Israel
    Mexico
    Peru
    South Africa
    Austria
    Estonia
    France
    Latvia
    Lithuania
    Poland
    Germany
    Italy
    Belgium
    Denmark
    Hungary
    Portugal
    Slovakia
    Turkey
    United Kingdom
    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
    The end of this clinical trial (Study 1001) is defined as the Last Visit of the Last Subject. The Last Visit is the closing visit done on day 91 [+10], or a telephone interview on day 91 [+10] in case the Last Subject is discharged before day 91, or has been transferred to another hospital.
    El final de este ensayo clínico (Estudio 1001) se define como la Última Visita del Último Sujeto. La Última Visita es la visita de cierre realizada en el día 91 [+10], o una entrevista telefónica en el día 91 [+10] en caso de que el Último Sujeto sea dado de alta antes del día 91, o haya sido trasladado a otro hospital.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 134
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-07-19. Yes
    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 Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 181
    F.4.2.2In the whole clinical trial 334
    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 Decision2022-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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