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    Summary
    EudraCT Number:2021-001228-17
    Sponsor's Protocol Code Number:CSIC-FDA277-2021-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-17
    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 number2021-001228-17
    A.3Full title of the trial
    A Randomized, double-blind, Repositioning Clinical Trial, placebo controlled, to Evaluate the Efficacy and Safety of FDA-277 in combination with standard of care in the Treatment of Infection Caused by SARS-CoV-2, in Patients With early Stage COVID-19 Disease, in Primary Heatlh Care setting.
    Ensayo clínico aleatorizado, doble ciego, de reposicionamiento terapéutico, comparativo con placebo, para evaluar la eficacia y seguridad de FDA-277 en combinación con el tratamiento estándar en el tratamiento de la infección producida por SARS-CoV-2, en pacientes en estadio inicial de la enfermedad COVID-19, con seguimiento en Atención Primaria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clincal trial to evaluate the efficacy of a marketed product (FDA-277) in combination with standard of care in the treatment of infection of COVID-19 in positive patients with or without symptoms in Primary Health Care
    Ensayo clínico para evaluar la eficacia de un fármaco comercializado (FDA-277) en combinación con el tratamiento estándar, en el tratamiento de la infección COVID-19 en pacientes positivos con o sin síntomas, en Atención Primaria
    A.3.2Name or abbreviated title of the trial where available
    CSIC-FDA277-2021-01
    CSIC-FDA277-2021-01
    A.4.1Sponsor's protocol code numberCSIC-FDA277-2021-01
    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 SponsorAGENCIA ESTATAL CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS, M.P. (CSIC)
    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 supportAGENCIA ESTATAL CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS, M.P. (CSIC)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationE-C-BIO, S.L.
    B.5.2Functional name of contact pointCoordination of study
    B.5.3 Address:
    B.5.3.1Street AddressRosa de Lima, 1, Of 016
    B.5.3.2Town/ cityLas Rozas
    B.5.3.3Post code28230
    B.5.3.4CountrySpain
    B.5.4Telephone number34916300480
    B.5.5Fax number34918582900
    B.5.6E-mailbsoler@ecbio.net
    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 Domperidona Pensa 10 mg comprimidos EFG
    D.2.1.1.2Name of the Marketing Authorisation holderPensa Pharma, S.A.
    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.3.1Product nameFDA277
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2 virus infection
    Infección por virus SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infección 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of FDA-277 combined with standard of care on reducing the SARS-CoV-2 viral load.
    El objetivo principal es evaluar la eficacia de FDA-277 combinado con tratamiento estándar sobre la reducción de la carga viral de SARS-CoV-2 desde el inicio del tratamiento.
    E.2.2Secondary objectives of the trial
    • To evaluate the laboratory efficacy of FDA-277 combined with standard care, in PCR, SARS CoV 2, negative after baseline.
    • To evaluate the clinical efficacy of FDA-277 combined with standard of care in reducing the proportion of patients presenting with symptoms of COVID-19 disease in the asymptomatic patient group.
    • To evaluate the clinical efficacy of FDA-277 combined with standard of care in reducing the symptoms of COVID 19 disease.
    • To evaluate the efficacy of FDA-277 combined with standard of care on the need for medical care, hospitalization, oxygen therapy, or mortality through day 28 from baseline.
    • To evaluate the safety of FDA-277 administered in patients infected with SARS CoV-2.
    • Evaluar la eficacia analítica de FDA-277 combinado con tratamiento estándar en la negativización de la PCR, negativa a SARS-CoV-2 desde el inicio del tratamiento.
    • Evaluar la eficacia clínica de FDA-277 combinado con tratamiento estándar en la reducción de la proporción de pacientes que presentan síntomas de la enfermedad COVID-19 en el grupo de pacientes asintomáticos.
    • Evaluar la eficacia clínica de FDA-277 combinado con tratamiento estándar en la reducción de los síntomas de la enfermedad COVID-19.
    • Evaluar la eficacia de FDA-277 combinado con tratamiento estándar en la necesidad de atención médica, hospitalización, oxigenoterapia o mortalidad hasta el día 28 desde el inicio del tratamiento.
    • Evaluar la seguridad de FDA-277 administrada en pacientes infectados por SARS-CoV-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient, of either sex, 18 years of age or older.
    2. Patient with weight higher than 35 Kg.
    3. Patient with a diagnosis of active SARS-CoV-2 infection confirmed by:
    a. Compatible symptoms (fever, cough, shortness of breath or difficulty breathing, sore throat, body or muscle pain, fatigue, headache, chills, nasal congestion, loss of taste or smell, nausea, vomiting, diarrhea) and a positive result in the detection tests for active infection (PDIA) rapid antigen detection test or in the PCR test for viral RNA detection.
    b. Patient without symptoms with a positive test result in the detection tests for active infection (PDIA) rapid antigen detection test or in the PCR test for viral RNA detection.
    4. Patients presenting with symptoms must present within the last 72 hours with one or more of the following symptoms associated with SARS-CoV-2 infection: fever, cough, dyspnea or shortness of breath, sore throat, body or muscle pain, fatigue, headache.
    5. In patients with symptoms due to SARS-CoV-2 infection, the severity of symptoms should be mild or moderate.
    6. The patient has received sufficient information about the study orally and in writing and has signed the informed consent to participate in the clinical trial.
    1. 1. Paciente, de cualquier sexo, de 18 años o mayor.
    2. Paciente con peso mayor de 35 Kg
    3. Paciente con diagnóstico de infección activa por SARS-CoV-2 confirmado por:
    a. Síntomas compatibles (fiebre, tos, disnea o dificultad para respirar, dolor de garganta, dolor corporal o muscular, fatiga, cefalea, escalofríos, congestión nasal, pérdida del sentido del gusto o del olfato, náuseas, vómitos, diarrea) y resultado positivo en las pruebas de detección de infección activa (PDIA) prueba rápida de detección de antígenos o en la prueba PCR de detección de ARN viral.
    b. Paciente sin síntomas con resultado positivo en las pruebas de detección de infección activa (PDIA) prueba rápida de detección de antígenos o en la prueba PCR de detección de ARN viral en las últimas 72 horas.
    4. Los pacientes que presenten síntomas deben presentar en las últimas 72 horas uno o más de los siguientes síntomas asociados a la infección por SARS-CoV-2: fiebre, tos, disnea o dificultad para respirar, dolor de garganta, dolor corporal o muscular, fatiga, cefalea.
    5. En los pacientes con síntomas por infección por SARS-CoV-2 la intensidad de los síntomas debe ser leve o moderada.
    6. El paciente ha recibido información suficiente sobre el estudio de forma oral y por escrito y ha firmado el consentimiento informado para participar en el ensayo clínico.
    E.4Principal exclusion criteria
    1. Patient living with a patient who has previously been included in the study who continues in follow up (until day 28).
    2. Patient who meets any of the following criteria for disease severity:
    • Need for hospitalization.
    • Respiratory rate ≥30 breaths per minute.
    • More than 100 beats per minute.
    • Moderate-severe dyspnea (Class II-IV NYHA - resting dyspnea, or withs slight effort or with moderate effort)
    • Thoracic-pleuritic pain.
    • Persistent hemoptysis.
    • Oxygen saturation <94% determined by pulse oximetry.
    • Systolic blood pressure≤90 mmHg or diastolic blood pressure ≤60 mmHg.
    • Signs of disseminated intravascular coagulation: hemorrhages (generalized cutaneous-mucosa or small wound); thrombosis (purpura fulminans, peripheral acrocyanosis, gangrene in extremities).
    • Chest X-ray with bilateral infiltrates, condensations, ground glass opacities.
    • Need for oxygen therapy.
    • Symptoms of shock.
    3. Patient has any of the following diseases that may be affected or affect the results of the study:
    • Active infectious disease other than SARS-CoV-2 infection requiring systemic therapy.
    • Clinically significant uncontrolled respiratory disease.
    • Prior cardiovascular disease: ischemic heart disease, heart failure, atrial fibrillation.
    • Severe kidney failure.
    • Active or treated malignancy.
    • Immunosuppression due to an illness or the treatment received.
    • Illness requiring surgical intervention within 30 days following the screening for the study.
    • Severe obesity.
    • Other diseases that the physician believes may pose an increased risk to the patient.
    4. Contraindications for FDA-277:
    • Patient with hypersensitivity to FDA-277 or to any of the excipients.
    • Patients with a prolactin-secreting pituitary tumor (prolactinoma).
    • Patients in whom stimulation of gastric motility can be dangerous, such as gastrointestinal bleeding, mechanical obstruction or perforation
    • Patient with moderate to severe liver failure, with results in liver function tests, aspartate transaminase, alanine transaminase, alkaline phosphatase ≥ 5 times the upper limit of normal.
    • Patient who presents clinically significant abnormalities in the 12-lead electrocardiogram performed during the selection period for the study, specifically existing prolongation of the cardiac conduction intervals, QTc interval.
    • Patient with underlying heart disease such as congestive heart failure or bradycardia.
    • Patient with significant electrolyte disturbances such as hypokalaemia, hyperkalaemia, hypomagnesemia.
    • Patient being treated with drugs that prolong the QT interval.
    • Patient receiving strong CYP3A4 inhibitor drugs.
    5. Pregnant women.
    6. Breast-feeding women.
    7. A patient with mental impairment that invalidates his/her ability to consent to participate in the study, or that limits his/her ability to comply with the study requirements, or that is expected to be non-cooperative.
    8. Patient on treatment with drugs with known antiviral potential.
    9. Participation in a clinical trial within the last month.
    1. Paciente conviviente con un paciente que se haya incluido en el estudio con anterioridad y que continúe en seguimiento (hasta el día 28).
    2. Paciente que cumpla alguno de los siguientes criterios de gravedad de la enfermedad:
    • Necesidad de hospitalización.
    • Frecuencia respiratoria ≥ 30 respiraciones por minuto.
    • Más de 100 latidos por minuto.
    • Disnea moderada-grave (Clase II-IV NYHA - disnea en reposo, o con escasa actividad, o con actividad moderada)
    • Dolor torácico-pleurítico.
    • Hemoptisis persistente.
    • Saturación de oxígeno < 94% determinada por pulsioximetría.
    • Presión arterial sistólica ≤90 mmHg o presión arterial diastólica ≤60 mmHg.
    • Signos de coagulación intravascular diseminada: hemorragias (cutáneo-mucosas generalizadas o por pequeña herida); trombosis (púrpura fulminante, acrocianosis periférica, gangrena en extremidades).
    • Radiografía de tórax con infiltrados bilaterales, condensaciones, opacidades en vidrio deslustrado.
    • Necesidad de oxigenoterapia.
    • Síntomas de shock.
    3. Paciente que presente alguna de las siguientes enfermedades que puedan verse afectadas o afectar a los resultados del estudio:
    • Enfermedad infecciosa activa diferente a la infección por SARS-CoV-2 que requiera tratamiento sistémico.
    • Enfermedad respiratoria clínicamente significativa no controlada.
    • Enfermedad cardiovascular: cardiopatía isquémica, insuficiencia cardíaca, fibrilación auricular.
    • Insuficiencia renal grave.
    • Neoplasia maligna activa o en tratamiento.
    • Inmunosupresión debido a una enfermedad o al tratamiento que recibe.
    • Enfermedad que requiera una intervención quirúrgica en el periodo de 30 días posteriores a la selección para el estudio.
    • Obesidad grave.
    • Otras enfermedades que el médico considere que pueda suponer un aumento del riesgo para el paciente.
    4. Contraindicaciones de FDA-277:
    • Paciente con hipersensibilidad a FDA-277 o a cualquiera de los excipientes.
    • Pacientes con tumor hipofisario secretor de prolactina (prolactinoma).
    • Pacientes en los que la estimulación de la motilidad gástrica pueda ser peligrosa, como hemorragia gastrointestinal, obstrucción mecánica o perforación
    • Paciente con insuficiencia hepática moderada a grave, con resultado en las pruebas de función hepática, aspartato transaminasa, alanina transaminasa, fosfatasa alcalina ≥ 5 veces el límite superior de la normalidad.
    • Paciente que presenta anomalías clínicamente significativas en el electrocardiograma de 12 derivaciones realizado durante el periodo de selección para el estudio, en concreto prolongación existente de los intervalos de conducción cardíaca, intervalo QTc.
    • Paciente con cardiopatías subyacentes como insuficiencia cardíaca congestiva o con bradicardia.
    • Paciente con trastornos electrolíticos importantes como hipopotasemia, hiperpotasemia, hipomagnesemia.
    • Paciente en tratamiento con fármacos que prolongan el intervalo QT.
    • Paciente en tratamiento con fármacos inhibidores potentes del CYP3A4.
    5. Mujeres embarazadas.
    6. Mujeres en periodo de lactancia.
    7. Paciente con alteración mental que invalide su capacidad para consentir en participar en el estudio, o que limite su capacidad para cumplir con los requisitos del estudio, o que se prevea que no será colaborador.
    8. Paciente en tratamiento con fármacos con potencial antiviral conocido.
    9. Participación en un ensayo clínico en el último mes.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    • To compare the reduction in viral load (Basal-4 days difference in SARS-CoV-2 copy number) of FDA-277 plus standard of care-treated group versus the standard of care group as an assessment of efficacy at day 4.
    Criterio de valoración principal de la eficacia
    • Comparar la reducción de la carga viral (diferencia Basal-4 días en el número de copias de SARS-CoV-2) del grupo de pacientes tratados con FDA-277 en combinación con el tratamiento estándar versus el grupo de tratamiento estándar como evaluación de la eficacia a los 4 días desde el inicio del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 4
    Día 4
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • To compare the reduction in viral load (Basal-7 days difference, Basal-14 days difference, in SARS-CoV-2 copy number) of FDA-277 plus standard of care-treated group versus placebo plus standard of care as an assessment of efficacy at 7 and 14 days from baseline.
    • Proportion of patients with negative SARS-CoV-2 PCR result at 4, 7, and 14 days from baseline.
    • Time from baseline to obtainment of a negative PCR test for SARS-CoV-2.
    • To evaluate the clinical efficacy of FDA-277 in reducing the symptoms of COVID-19 disease.
    o The proportion of asymptomatic patients at baseline with one or more symptoms until day 14 and Day 28 or EOS
    o Reduction in severity of each symptom (0 to 10 point scale) related to SARS-CoV-2 disease at 4, 7, 14, and 28 days or EOS from baseline.
    o Proportion of patients with clinical improvement, defined as improvement by two or more points on a scale of 0 to 10 points.
    o Time to clinical improvement.
    o Proportion of patients in whom each symptom related to SARS-CoV-2 disease disappears at 4, 7, 14, and 28 days from baseline.
    o Proportion of patients with no symptoms at 4, 7, 14 and 28 days from baseline.
    o Time to disappearance of each symptom related to SARS-CoV-2 disease from baseline.
    • To evaluate the efficacy of FDA-277 on the need for medical care, hospitalization, oxygen therapy, or mortality through day 28 from baseline.
    o Proportion of patients requiring hospitalization, oxygen therapy, or who develop complications from SARS-CoV-2 disease through Day 28 from baseline.
    o Proportion of patients who die within the 28-day follow-up period and reported mortality within three months of study end.
    • To evaluate the safety of FDA-277 in patients with COVID-19 disease.
    Criterios secundarios de valoración exploratoria de la eficacia:
    • Comparar la reducción de la carga viral (diferencia Basal-7 días, Basal-14 días, en el número de copias de SARS-CoV-2) del grupo de pacientes tratados con FDA-277 combinado con tratamiento estándar versus placebo más tratamiento estándar como evaluación de la eficacia a los 7 y 14 días desde el inicio del tratamiento.
    • Proporción de pacientes con resultado negativo en la PCR a SARS-CoV-2 a los 4, 7, y 14 días desde el inicio del tratamiento.
    • Tiempo desde el inicio del tratamiento hasta la obtención de un resultado negativo en la PCR a SARS-CoV-2.
    • Evaluar la eficacia clínica de FDA-277 combinado con tratamiento estándar en la reducción de los síntomas de la enfermedad COVID-19.
    o Proporción de pacientes asintomáticos al inicio del tratamiento que presentan uno o más síntomas hasta el día 14 y 28 o FDE.
    o Reducción en la intensidad de cada síntoma (escala de 0 a 10 puntos) relacionado con la enfermedad SARS-CoV-2 a los 4, 7, 14 y 28 días o FDE desde el inicio del tratamiento.
    o Proporción de pacientes con mejoría clínica, definida como la mejoría en dos o más puntos en la escala de 0 a 10 puntos.
    o Tiempo hasta la mejoría clínica.
    o Proporción de pacientes en los que desaparece cada síntoma relacionado con la enfermedad por SARS-CoV-2 a los 4, 7, 14 y 28 días desde el inicio del tratamiento.
    o Proporción de pacientes sin síntomas a los 4, 7, 14 y 28 días desde el inicio del tratamiento.
    o Tiempo hasta la desaparición de cada síntoma relacionado con la enfermedad SARS-CoV-2 desde el inicio del tratamiento.
    • Evaluar la eficacia de FDA-277 combinado con tratamiento estándar en la necesidad de atención médica, hospitalización, oxigenoterapia o mortalidad hasta el día 28 desde el inicio del tratamiento.
    o Proporción de pacientes que precisan hospitalización, oxigenoterapia o presenta complicaciones de la enfermedad por SARS-CoV-2 hasta el día 28 desde el inicio del tratamiento.
    o Proporción de pacientes que fallecen en el periodo de seguimiento de 28 días y mortalidad comunicada en los tres meses posteriores a la finalización del estudio.
    • Evaluar la seguridad de FDA-277 en pacientes con enfermedad COVID-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, Day 14, Day 28
    Día 7, día 14, día 28
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Reposicionamiento terapéutico
    Therapeutic repositioning
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento habitual
    Standar of care
    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 concerned13
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 160
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 40
    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 2021-12-17. 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 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
    Older than 65
    Mayores de 65 años
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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)
    Standard of care
    Tratamiento habitual
    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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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