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    Summary
    EudraCT Number:2020-001031-27
    Sponsor's Protocol Code Number:CQ4COV19
    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:2020-04-03
    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 number2020-001031-27
    A.3Full title of the trial
    Treatment of non-severe confirmed cases of COVID-19 and chemoprophylaxis of their contacts as prevention strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)
    Tratamiento de casos confirmados no graves de COVID-19 y quimioprofilaxis de sus contactos como estrategia de prevención: ensayo clínico aleatorizado por grupos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of non-severe confirmed cases of coronavirus and treatment of their contacts as prevention
    Tratamiento de casos confirmados no graves de coronavirus y tratamiento de sus contactos como prevención
    A.3.2Name or abbreviated title of the trial where available
    Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention
    Tratamiento de casos COVID-19 y quimioprofilaxis de contactos como prevención
    A.4.1Sponsor's protocol code numberCQ4COV19
    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 SponsorFUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
    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 supportFUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportDepartament de Salut, Generalitat de Catalunya
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportInstitut Català de la Salut, Generalitat de Catalunya
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportLaboratorios Rubió SA
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportLaboratorios Gebro pharma SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Lluita contra la SIDA
    B.5.2Functional name of contact pointFLS-Reseach Support
    B.5.3 Address:
    B.5.3.1Street AddressCtra Canyet sn
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number3493497 84 14
    B.5.5Fax number3493465 76 02
    B.5.6E-mailsgel@flsida.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rezolsta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 Film-coated 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 INNDARUNAVIR
    D.3.9.1CAS number 206361-99-1
    D.3.9.4EV Substance CodeSUB25394
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Dolquine
    D.2.1.1.2Name of the Marketing Authorisation holderPRODUCTS AND TECHNOLOGY S.L.,
    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 Film-coated 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 number200
    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
    SARS-CoV-2 Respiratory Viral Infection
    Infección viral respiratoria por SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Respiratory Viral Infection/ Coronavirus
    Infección viral respiratoria / coronavirus
    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 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Evaluate the transmissibility of SARS-CoV-2 and reduction of disease progression within the study population over the course of the outbreak.
    -Explore the effect of the intervention on patient individual parameters.
    - Evaluar la transmisibilidad del SARS-CoV-2 y la reducción de la progresión de la enfermedad en la población de estudio durante el curso del brote.
    - Explorar el efecto de la intervención en los parámetros individuales del paciente
    E.2.2Secondary objectives of the trial
    -Feasibility of implementation of treatment strategy
    -Cost effectiveness of test-and-treat intervention

    -Viabilidad de la implementación de la estrategia de tratamiento.
    - Costo efectividad de la intervención de prueba y tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Index Cases:
    1.Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
    2.Aged ≥18 years male or female
    3.In women of childbearing potential(1), negative pregnancy test and commitment to use contraceptive method(2) throughout the study.
    4.Willing to take study medication
    5.Willing to comply with all study procedures, including repeat nasal swab at day 3
    6.Able to provide oral and written informed consent

    2Contraceptive methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study.
    Data currently available in population older than 65 years are limited, so caution will be taken before administering Rezolsta to patients of this age. This will be minimized as a thorough review of the clinical records including laboratory tests in advance.

    Inclusion Criteria for contacts:
    1.Patients who meet the definition of a contact according to the Catalan Public Health Department Guidelines
    2.Aged ≥18 years male or female;
    3.Willing to take study medication;
    4.Willing to comply with all study procedures;
    5.Able to provide oral, informed consent and/or assent.
    Criterios de inclusión para los casos:
    Pacientes que cumplen con los requisitos del nuevo diagnóstico de infección por coronavirus (síntomas de infección respiratoria aguda o tos aguda sola y PCR positiva)
    2. Edad ≥18 años hombre o mujer
    3. En mujeres en edad fértil (1), prueba de embarazo negativa y compromiso de usar método anticonceptivo (2) durante todo el estudio.
    4.Dispuesto a tomar medicación del estudio
    5.Dispuesto a cumplir con todos los procedimientos del estudio, incluida la repetición del hisopo nasal en el día 3
    6. Capaz de proporcionar consentimiento informado oral y escrito

    2 Métodos anticonceptivos: condón masculino o femenino con o sin espermicida, capuchón, diafragma o esponja con o sin espermicida, dispositivo intrauterino, oclusión tubárica bilateral, pareja vasectomizada, abstinencia sexual durante el estudio.
    Los datos disponibles actualmente en la población mayor de 65 años son limitados, por lo que se debe tener precaución antes de administrar Rezolsta a pacientes de esta edad. Esto se minimizará como una revisión exhaustiva de los registros clínicos, incluidas las pruebas de laboratorio por adelantado.

    Criterios de inclusión para contactos:
    1. Pacientes que cumplen con la definición de un contacto de acuerdo con las Directrices del Departamento de Salud Pública de Cataluña
    2. Edad ≥18 años hombre o mujer;
    3. Deseos de tomar la medicación del estudio;
    4. Deseos de cumplir con todos los procedimientos de estudio;
    5. Capaz de proporcionar consentimiento y / o asentimiento oral e informado.
    E.4Principal exclusion criteria
    Exclusion Criteria for Index Cases:
    1.Serious condition meeting one of the following: (1) respiratory distress with respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration<=300mmHg;
    2.Critically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;
    3.Participants under treatment with medications likely to interfere with experimental drugs Unable to take drugs by mouth;
    4.With significantly abnormal liver function (Child Pugh C)
    5.Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
    6.Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
    7.Participants with severe neurological and mental illness;
    8.Pregnant or lactating women;
    9.Inability to consent and/or comply with study protocol;
    10.Individuals with known hypersensitivity to the study drugs;
    11.Persons already treated with any of the study drugs during the last 30 days.
    12.Concomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.
    13.HIV patients (because these are already on antiretroviral treatment)
    14.Any contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.

    Exclusion Criteria for contacts:
    1. Participants under treatment with medications likely to interfere with experimental drugs
    2. Unable to take drugs by mouth;
    3. With significantly abnormal liver function (Child Pugh C)
    4. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
    5. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit Participants with retinal disease, hearing loss;
    6. Persons already treated with any of the study drugs during the last 30 days;
    7. Pregnant or lactating women;
    8. Any contraindications as per the Data Sheet of Hydroxychloroquine.
    Criterios de exclusión para los casos:
    1. Condición grave que cumple uno de los siguientes: (1) dificultad respiratoria con frecuencia respiratoria> = 30 respiraciones / min; (2) saturación de oxígeno <= 93% en estado silencioso; (3) Presión parcial de oxígeno arterial (PaO2) / concentración de oxígeno <= 300 mmHg;
    2. Pacientes críticos que cumplen con uno de los siguientes: (1) Experimentan insuficiencia respiratoria y necesitan recibir ventilación mecánica; (2) Experiencia de choque; (3) Complicación con fallo de otros órganos y necesita cuidados intensivos y terapia en la UCI;
    3.Participantes en tratamiento con medicamentos que puedan interferir con medicamentos experimentales. No pueden tomar medicamentos por vía oral;
    4.Con una función hepática significativamente anormal (Child Pugh C)
    5.Necesidad de tratamiento de diálisis, o GFR≤30 mL / min / 1.73 m2;
    6.Participantes con psoriasis, miastenia, enfermedades hematopoyéticas y retinianas, hipoacusia relacionada con el SNC o déficit de glucosa-6-fosfato deshidrogenasa
    7. Participantes con enfermedades neurológicas y mentales severas;
    8. Mujeres embarazadas o lactantes;
    9. Incapacidad para consentir y / o cumplir con el protocolo del estudio;
    10. Individuos con hipersensibilidad conocida a los fármacos del estudio;
    11. Personas ya tratadas con cualquiera de los medicamentos del estudio durante los últimos 30 días.
    12. Administración concomitante de inductores enzimáticos (como la carbamazepina) que podrían conducir a la ineficacia de darunavir; y aquellos que reciben sustratos de CYP3A4 (como las estatinas) debido al riesgo de mayor toxicidad.
    13. Pacientes con VIH (porque ya están en tratamiento antirretroviral)
    14.Cualquier contraindicación según la Ficha técnica de Rezolsta o Hidroxicloroquina.



    Criterios de exclusión para contactos:
    1.Con antecedentes conocidos de arritmia cardíaca (o síndrome de prolongación QT);
    1. Participantes bajo tratamiento con medicamentos que puedan interferir con medicamentos experimentales.
    2. Incapaz de tomar medicamentos por vía oral;
    3. Con una función hepática significativamente anormal (Child Pugh C)
    4. Necesidad de tratamiento de diálisis, o GFR≤30 mL / min / 1.73 m2;
    5. Participantes con psoriasis, miastenia, enfermedades hematopoyéticas y retinianas, pérdida auditiva relacionada con el SNC o déficit de glucosa-6-fosfato deshidrogenasa. Participantes con enfermedad retiniana, pérdida auditiva;
    6. Personas ya tratadas con cualquiera de los medicamentos del estudio durante los últimos 30 días;
    7. Mujeres embarazadas o lactantes;
    8. Cualquier contraindicación según la Ficha técnica de Hidroxicloroquina.
    E.5 End points
    E.5.1Primary end point(s)
    Outcome Measures [Population level]:
    1.Ring prophylaxis effectiveness to reduce development of disease assessed by Incidence of secondary cases (basic case reproduction number) among contacts of a case
    2.Ring prophylaxis effectiveness to reduce transmissibility assessed by PCR conversion to positive of contacts that are negative at baseline

    Outcome Measures [COVID-19 case Individual outcomes]:
    1.Symptom type, duration and severity among SARS-CoV-2 positive cases [
    [Nivel de población]:
    1. Efectividad de la profilaxis en anillo para reducir el desarrollo de la enfermedad evaluada por la incidencia de casos secundarios (número de reproducción del caso básico) entre los contactos de un caso
    2. Eficacia de la profilaxis en anillo para reducir la transmisibilidad evaluada por conversión de PCR positiva de los contactos que eran negativos al inicio

    [COVID-19 Resultados individuales]:
    1.Tipo de síntoma, duración y gravedad entre los casos positivos de SARS-CoV-2
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 14 days after start of treatment
    Hasta 14 días después del inicio del tratamiento.
    E.5.2Secondary end point(s)
    Outcome Measures [Population level]:
    3.Feasibility of implementation of treatment strategy
    4.Cost effectiveness of test-and-treat intervention

    Outcome Measures [COVID-19 case Individual outcomes]:
    2.The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3
    3.The mortality rate of subjects at weeks 2
    4.Proportion of participants that drop out of study
    5.Proportion of participants that show non-compliance with study drug
    6.Proportion of participants that show non-compliance with public health measures
    7.Drug levels and biomarkers of severity of infection
    [Nivel de población]:
    3. Viabilidad de la implementación de la estrategia de tratamiento
    4. Costo efectividad de la intervención de prueba y tratamiento

    [Caso COVID-19 Resultados individuales]:
    2. La tasa de depuración virológica de los hisopos de garganta, el esputo o las secreciones del tracto respiratorio inferior en los días 3
    3. La tasa de mortalidad de los sujetos en las semanas 2
    4. Proporción de participantes que abandonan el estudio.
    5. Proporción de participantes que muestran incumplimiento con el fármaco del estudio.
    6. Proporción de participantes que muestran incumplimiento de las medidas de salud pública.
    7. Niveles de fármacos y biomarcadores de la gravedad de la infección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 6 months
    Hasta 6 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Incidence
    Incidencia
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sin intervención: vigilancia estándar de SARS-CoV-2
    No Intervention: Standard SARS-CoV-2 surveillance
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    última visita último sujeto
    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
    E.8.9.2In all countries concerned by the trial months3
    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: 2432
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 608
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    Mayor
    F.4 Planned number of subjects to be included
    F.4.1In the member state3040
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Departamen de Salut
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Centre for Epidemiological Studies on Sexually Transmitted Diseases and HIV/AIDS of Catalonia (CEEISCAT)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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