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    Summary
    EudraCT Number:2020-001827-15
    Sponsor's Protocol Code Number:CORTIVID
    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 number2020-001827-15
    A.3Full title of the trial
    EARLY TREATMENT OF PNEUMONIA COVID-19 WITH GLUCOCORTICOIDS.
    RANDOMIZED CONTROLLED CLINICAL TRIAL
    TRATAMIENTO PRECOZ DE LA NEUMONÍA COVID-19 CON GLUCOCORTICOIDES.
    ENSAYO CLÍNICO CONTROLADO ALEATORIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EARLY TREATMENT OF PNEUMONIA COVID-19 WITH GLUCOCORTICOIDS.
    RANDOMIZED CONTROLLED CLINICAL TRIAL
    TRATAMIENTO PRECOZ DE LA NEUMONÍA COVID-19 CON GLUCOCORTICOIDES.
    ENSAYO CLÍNICO CONTROLADO ALEATORIZADO
    A.3.2Name or abbreviated title of the trial where available
    CORTIVID
    CORTIVID
    A.4.1Sponsor's protocol code numberCORTIVID
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
    B.5.2Functional name of contact pointCLINICAL TRIAL UNIT
    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 Methylprednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderMethylprednisolone
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE
    D.3.9.1CAS number 2375-03-3
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM HEMISUCCINATE
    D.3.9.4EV Substance CodeSUB26423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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: 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 number400 to 100
    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 TOCILIZUMAB
    D.2.1.1.2Name of the Marketing Authorisation holderTOCILIZUMAB
    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 Powder and solvent for suspension 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 INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number162
    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.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
    CoVid-19 pneumonia in early inflammatory phase (stage II).
    Neumonía CoVid-19 en fase inflamatoria precoz (estadío II).
    E.1.1.1Medical condition in easily understood language
    CoVid-19 pneumonia in early inflammatory phase (stage II).
    Neumonía CoVid-19 en fase inflamatoria precoz (estadío II).
    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 efficacy of glucocorticoid boluses in the inflammatory phase of SARS-CoV-2 pneumonia.
    Evaluar la eficacia de los bolos de glucocorticoides en la fase inflamatoria de la neumonía por SARS-CoV-2.
    E.2.2Secondary objectives of the trial
    • Compare mortality at 28 days.
    • Compare the proportion of ICU admissions at 28 days.
    • Compare the ratio need for rescue treatment with tocilizumab at 14 days.
    • Compare the days of hospital admission.
    • Compare the evolution of the analytical parameters of inflammation: C-reactive protein (PCR), interleukin 6 (IL-6), ferritin, D-dimer (DD).
    • Compare the proportion of serious adverse events.
    • Compare the proportion of bacterial, fungal, or opportunistic infections.
    • Compare the clearance of the virus detected by nasopharyngeal PCR.
    •Comparar la mortalidad a los 28 días.
    •Comparar la proporción de ingresos en UCI a los 28 días.
    •Comparar la proporción necesidad de tratamiento de rescate con tocilizumab a los 14 días.
    •Comparar los días de ingreso hospitalario.
    •Comparar la evolución de los parámetros analíticos de inflamación: proteína C reactiva (PCR), interleuquina 6 (IL-6), ferritina, D-dímero (DD).
    •Comparar la proporción de acontecimientos adversos graves.
    •Comparar la proporción de infecciones bacterianas, fúngicas u oportunistas.
    •Comparar el aclaramiento del virus detectado por PCR nasofaríngea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years.
    • Diagnosis of SARS-CoV-2 pneumonia by reverse transcriptase polymerase chain reaction (RT-PCR) in nasopharyngeal or sputum smears according to the recommendations of the Ministry of Health.
    • Duration of symptoms ≥ 7 days.
    • At least one of the following: C-reactive protein (PCR)> 60 mg / L or interleukin 6 (IL-6)> 40 pg / mL or ferritin> 1000 μg / L.
    • Acceptance of informed consent.
    •Edad ≥18 años.
    •Diagnóstico de neumonía por SARS-CoV-2 mediante reacción en cadena de la polimerasa con transcriptasa inversa (RT-PCR) en frotis nasofaríngeo o esputo de acuerdo con las recomendaciones del Ministerio de Sanidad.
    •Duración de los síntomas ≥ 7 días.
    •Al menos una de las siguientes: proteína C reactiva (PCR) >60 mg/L o interleuquina 6 (IL-6) >40 pg/mL o ferritina >1000 μg/L.
    •Aceptación del consentimiento informado.
    E.4Principal exclusion criteria
    • Allergy or contraindication to the drugs under study.
    • Respiratory failure data: SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2 / FiO2 <300 mmHg.
    • Need for glucocorticoids or immunosuppressants (including biological ones) with another indication.
    • Decompensated diabetes mellitus.
    • Uncontrolled hypertension.
    • Psychotic or manic disorder.
    • Active cancer.
    • Pregnancy or lactation.
    • Clinical or biochemical suspicion (procalcitonin> 0.5 ng / mL) of active infection other than SARS-CoV-2.
    • Out-of-hospital management patient.
    • Conservative or palliative management patient.
    • Participation in another clinical trial.
    • Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
    • Alergia o contraindicación a los medicamentos en estudio.
    • Datos de insuficiencia respiratoria: SpO2 <90% (a aire ambiente) o PaO2 <60 mmHg (a aire ambiente) o PaO2/FiO2 <300 mmHg.
    • Necesidad de glucocorticoides o inmunosupresores (incluidos los biológicos) con otra indicación.
    • Diabetes mellitus descompensada.
    • Hipertensión arterial no controlada.
    • Trastorno psicótico o maníaco.
    • Cáncer activo.
    • Embarazo o lactancia.
    • Sospecha clínica o bioquímica (procalcitonina >0,5 ng/mL) de infección activa diferente a SARS-CoV-2.
    • Paciente de manejo extrahospitalario.
    • Paciente de manejo conservador o paliativo.
    • Participación en otro ensayo clínico.
    • Cualquier problema médico, psicológico, psiquiátrico, geográfico o social importante y no controlado que contraindique la participación del paciente en el ensayo o que no permitan un adecuado seguimiento y adherencia con el protocolo y evaluación de los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with treatment failure up to 14 days after randomization.
    Definition of treatment failure:
    to. Death of the patient, or
    b. ICU admission, or
    c. Start of mechanical ventilation, or
    d. Clinical deterioration / worsening, defined as decrease in SpO2 below 90% or PaO2 below 60 mmHg in ambient air + radiological progression.
    Proporción de pacientes con fallo de tratamiento hasta los 14 días después de la aleatorización.
    Definición de fallo de tratamiento:
    a. Muerte del paciente, o bien
    b. Ingreso en UCI, o bien
    c. Inicio de ventilación mecánica, o bien
    d. Deterioro / empeoramiento clínico, definido como descenso de SpO2 por debajo de 90% o de PaO2 por debajo de 60 mmHg a aire ambiente + progresión radiológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 DAYS OF HOSPITALISATION
    14 DÍAS DE HOSPITALIZACIÓN
    E.5.2Secondary end point(s)
    • Mortality 28 days after randomization.
    • Proportion of ICU admissions 28 days after randomization.
    • Proportion of rescue treatment with tocilizumab or with methylprednisolone + tocilizumab 14 days after randomization.
    • Days of hospital stay.
    • Proportion of serious adverse events.
    • Proportion of bacterial, fungal or opportunistic infections.
    • Differences in the analytical parameters indicative of inflammation (PCR, IL-6, ferritin, D-dimer) 14 days after randomization.
    • Clearance of the virus detected by nasopharyngeal RT-PCR at 7 days.
    • Mortalidad a los 28 días de la aleatorización.
    • Proporción de ingresos en UCI a los 28 días de la aleatorización.
    • Proporción de tratamiento de rescate con tocilizumab o con metilprednisolona + tocilizumab a los 14 días de la aleatorización.
    • Días de estancia hospitalaria.
    • Proporción de acontecimientos adversos graves.
    • Proporción de infecciones bacterianas, fúngicas u oportunistas.
    • Diferencias en los parámetros analíticos indicativos de inflamación (PCR, IL-6, ferritina, dímero D) a los 14 días de la aleatorización.
    • Aclaramiento del virus detectado por RT-PCR nasofaríngea a los 7 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 DAYS OF HOSPITALISATION
    28 DÍAS DE HOSPITALIZACIÓN
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    ULTIMA VISITA DEL ULTIMO SUJETO RECLUTADO
    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 months4
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state72
    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 Decision2020-04-30
    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
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