Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001825-29
    Sponsor's Protocol Code Number:ANA-COVID-GEAS
    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:2020-05-05
    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 number2020-001825-29
    A.3Full title of the trial
    CLINICAL TRIAL OF THE USE OF ANAKINRA (ANTI IL-1) IN CYTOKINE STORM SYNDROME (CSS) SECONDARY TO COVID-19
    ENSAYO CLÍNICO DEL USO DE ANAKINRA (ANTI IL-1) EN EL SÍNDROME DE TORMENTA DE CITOQUINA (CSS) SECUNDARIO DE COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL OF THE USE OF ANAKINRA (ANTI IL-1) IN CYTOKINE STORM SYNDROME (CSS) SECONDARY TO COVID-19
    ENSAYO CLÍNICO DEL USO DE ANAKINRA (ANTI IL-1) EN EL SÍNDROME DE TORMENTA DE CITOQUINA (CSS) SECUNDARIO DE COVID-19
    A.3.2Name or abbreviated title of the trial where available
    ANA-COVID-GEAS
    ANA-COVID-GEAS
    A.4.1Sponsor's protocol code numberANA-COVID-GEAS
    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 SponsorNAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
    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 supportISCIII
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportSOBI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCLINICAL TRIAL UNIT
    B.5.2Functional name of contact pointRUTH GARCIA
    B.5.3 Address:
    B.5.3.1Street AddressEDIFICIO LUNA, COMPLEJO HOSPITALARIO DE NAVARRA, C/IRUNLARREA Nº 3
    B.5.3.2Town/ cityPAMPLONA
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number0034848422163
    B.5.6E-mailruth.garcia.rey@navarra.es
    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 ANAKINRA
    D.2.1.1.2Name of the Marketing Authorisation holderANAKINRA
    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 syringe
    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 INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 HYDROXYCHLOROQUINE
    D.2.1.1.2Name of the Marketing Authorisation holderHYDROXYCHLOROQUINE
    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 Tablet
    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 INNHydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 LOPINAVIR/RITONAVIR
    D.2.1.1.2Name of the Marketing Authorisation holderLOPINAVIR/RITONAVIR
    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 Tablet
    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 INNLOPINAVIR/RITONAVIR
    D.3.9.3Other descriptive nameLOPINAVIR/RITONAVIR
    D.3.9.4EV Substance CodeSUB20529
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 200
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 AZYTHROMICINE
    D.2.1.1.2Name of the Marketing Authorisation holderAZYTHROMICINE
    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 Tablet
    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 INNAZITHROMYCIN DIHYDRATE
    D.3.9.3Other descriptive nameAZITHROMYCIN DIHYDRATE
    D.3.9.4EV Substance CodeSUB16399MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperinflammation and respiratory distress in patients with SARS- CoV-2
    Hiperinflamación y la dificultad respiratoria en pacientes con infección por SARS-CoV-2.
    E.1.1.1Medical condition in easily understood language
    Hyperinflammation and respiratory distress in patients with SARS- CoV-2
    Hiperinflamación y la dificultad respiratoria en pacientes con infección por SARS-CoV-2.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.
    Evaluar el efecto de la anakinra además del tratamiento estándar sobre la necesidad de ventilación mecánica en pacientes con neumonía grave por COVID-19 y CSS
    E.2.2Secondary objectives of the trial
    To assess the effect of anakinra in addition to standard treatment on mortality in patients with severe COVID-19 and CSS pneumonia.
    Evaluar el efecto de anakinra además del tratamiento estándar sobre la mortalidad en pacientes con neumonía grave por COVID-19 y CSS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Age 18-80 years.
     Severe pneumonia COVID-19 defined as:
    o Nasopharyngeal smear with RCP positive for SARS-CoV-2
    o X-Rays (or other technique) pulmonary infiltrates compatible with pneumonia.
    o 1 or more of the following criteria:
     Ambient air oxygen saturation <= 94% measured with a pulse oximeter.
     Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300.
     Sa:FiO2 (O2 saturation measured with pulse oximeter/ fraction of inspired O2) <=350.
    High suspicion of CSS that could resemble MAS-like: represented by IL-6 values > 40 pg/mL and/or ferritin >500 ug/L and/or PCR > 30 mg/L (rationale: ≥ 5 upper normal limit) and/or LDH >300 UI/L. We have chosen these parameters because they are implemented in all the participating hospitals, they are a reflection of the cytokine storm and they have also been significant in terms of predicting mortality in patients with COVID-19 (9).
     Written informed consent. The protocol will be explained to the patient in front of a nurse who will act as a legal witness by signing the document on behalf of the patient.
     Edad 18-80 años.
     Neumonía grave COVID-19 definida como:
    o frotis nasofaríngeo con PCR positivo para SARS-CoV-2
    o Rayos X (u otra técnica) infiltrados pulmonares compatibles con neumonía.
    o 1 o más de los siguientes criterios:
     Saturación de oxígeno en el aire ambiente <= 94% medido con un oxímetro de pulso.
     Pa: FiO2 (presión parcial O2 / fracción de O2 inspirado) <= 300.
     Sa: FiO2 (saturación de O2 medida con oxímetro de pulso / fracción de O2 inspirado) <= 350.
    Alta sospecha de CSS que podría parecerse a MAS: representado por valores de IL-6> 40 pg / ml y / o ferritina> 500 ug / L y / o PCR> 30 mg / L (justificación: ≥ 5 límite superior normal) y/o LDH >300 UI/L. Hemos elegido estos parámetros porque se implementan en todos los hospitales participantes, son un reflejo de la tormenta de citoquinas y también han sido significativos en términos de predicción de mortalidad en pacientes con COVID-19 (9).
     Consentimiento informado por escrito. El protocolo se explicará al paciente frente a una enfermera que actuará como testigo legal al firmar el documento en nombre del paciente.
    E.4Principal exclusion criteria
     Need for oro-tracheal intubation and/or invasive mechanical ventilation at the start of the study.
     AST/ALT with values greater than 5 times normal levels.
     Neutrophils < 1500 cell/mmc.
     Platelets < 50.000 cell/mmc.
     Sepsis or pneumonia documented by other pathogens than SARS-CoV-2.
     Existence of any life-threatening comorbidity or any other medical condition that, in the investigator's opinion, makes the patient unsuitable for inclusion.
     Inability to obtain informed consent.
     Positivity for HBV, HCV or tuberculin test serology.
     Pregnancy.
     Use of other previous or concomitant biological treatments. Patients in concomitant treatment with other biologicals that may interfere will be excluded: tocilizumab, canakinumab, TNFalfa inhibitors, JAKiinibs
     Severe renal dysfunction (estimated glomerular filtration rate ≤ 30 ml / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
     Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
     Administration of plasma from convalescent patients who have recovered from SARS-CoV-2 infection.
     History of hypersensitivity or allergy to any component of the study drug.
     Enrollment in another concurrent intervention clinical trial, or intake of an investigational medication within three months or 5 half-lives prior to inclusion in this study, if deemed to interfere with the objectives of this study as assessed by the investigator.
     Predictable inability to cooperate with given instructions or study procedures.
     Necesidad de intubación oro-traqueal y / o ventilación mecánica invasiva al inicio del estudio.
     AST / ALT con valores superiores a 5 veces los niveles normales.
     Neutrófilos < 1500 células / mmc.
     Plaquetas <50,000 células / mmc.
     Sepsis o neumonía documentada por otros patógenos distintos del SARS-CoV-2.
     Existencia de cualquier comorbilidad que ponga en peligro la vida o cualquier otra afección médica que, en opinión del investigador, haga que el paciente no sea apto para su inclusión.
     Incapacidad para obtener el consentimiento informado.
     Positividad para serología de prueba de VHB, VHC o tuberculina.
     Embarazo.
     Uso de otros tratamientos biológicos previos o concomitantes. Los pacientes en tratamiento concomitante con otros productos biológicos que puedan interferir serán excluidos: tocilizumab, canakinumab, inhibidores de TNFalfa, JAKiinibs
     Disfunción renal severa (tasa de filtración glomerular estimada ≤ 30 ml / min / 1.73 m2) o recibir terapia de reemplazo renal continuo, hemodiálisis o diálisis peritoneal.
     Hipertensión no controlada (presión arterial sistólica sentada> 180 mmHg o presión arterial diastólica> 110 mmHg).
     Administración de plasma de pacientes convalecientes que se han recuperado de la infección por SARS-CoV-2.
     Antecedentes de hipersensibilidad o alergia a cualquier componente del fármaco del estudio.
     La inscripción en otro ensayo clínico de intervención concurrente, o la ingesta de un medicamento en investigación dentro de los tres meses o 5 vidas medias antes de la inclusión en este estudio, si se considera que interfiere con los objetivos de este estudio según lo evaluado por el investigador.
     Incapacidad predecible para cooperar con las instrucciones dadas o los procedimientos de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success, defined as number of patients not requiring mechanical ventilation by Day 15.
    Number of patients not requiring mechanical ventilation (day 28). Time to mechanical ventilation (days)
     Time to oxygen saturation normalization
     Stay in ICU and hospitalization (days)
    Éxito del tratamiento, definido como el número de pacientes que no requieren ventilación mecánica para el día 15.
     Número de pacientes que no requieren ventilación mecánica (día 28).
     Tiempo de ventilación mecánica (días)
     Tiempo para la normalización de la saturación de oxígeno.
     Estancia en UCI y hospitalización (días)
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 days
    15 días
    E.5.2Secondary end point(s)
     Total mortality rate (day 28)
     Mortality 48 hours, 7 days, in ICU and hospital
     Viral clearance / viral shedding
     Frequency and severity of AEs:
    o Treatment-emergent severe fatal and life-threatening serious adverse events (SAEs).
    o Adverse events leading to premature discontinuation of study treatment.
    o Anaphylactic/anaphylactoid reactions.
    o Anakinra treatment group: Severe neutropenia.
    o Treatment-emergent laboratory abnormalities.
     Tasa de mortalidad total (día 28)
    Mortalidad 48 horas, 7 días, en UCI y hospital.
     Eliminación viral / diseminación viral
     Frecuencia y gravedad de los AA:
    o Eventos adversos graves (SAE) fatales graves y potencialmente mortales emergentes del tratamiento.
    o Eventos adversos que conducen a la interrupción prematura del tratamiento del estudio.
    o Reacciones anafilácticas / anafilactoides.
    o Grupo de tratamiento con Anakinra: neutropenia severa.
    o Anomalías de laboratorio emergentes del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 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 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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SIN ANAKINRA
    WITHOUT ANAKINRA
    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 concerned10
    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
    LVLS
    LVLS
    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 months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state180
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA