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    EudraCT Number:2020-001673-75
    Sponsor's Protocol Code Number:ABX464-401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-06-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001673-75
    A.3Full title of the trial
    A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the
    efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19
    associated acute respiratory failure in patients aged >/= 65 and patients aged >/=18 with
    at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE
    Estudio de fase 2/3, aleatorizado, en doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de ABX464 en el tratamiento de la inflamación y en la prevención de la insuficiencia respiratoria aguda resultante de la COVID-19 en pacientes >/= 65 años y en pacientes >/=18 años, estos últimos con como mínimo un factor de riesgo adicional, infectados con SARS-CoV-2. (Estudio MiR-AGE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2/3 study of ABX464, once daily oral capsule, in high risk patients infected by SARS-CoV-2 prior to respiratory distress.
    Estudio de fase 2/3 de ABX464, en cápsulas orales de administración una vez al día (QD), en pacientes de alto riesgo infectados por SARS-CoV-2 antes de la dificultad respiratoria debida a la COVID-19
    A.4.1Sponsor's protocol code numberABX464-401
    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 SponsorABIVAX
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportabivax
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationabivax
    B.5.2Functional name of contact pointClinical operations
    B.5.3 Address:
    B.5.3.1Street Address5 rue de la baume
    B.5.3.2Town/ cityparis
    B.5.3.3Post code75008
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ABX464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboCapsule, hard
    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
    Infection with SARS-CoV-2 virus, COVID-19 infection
    Infección por SARS-CoV-2, infección por COVID-19
    E.1.1.1Medical condition in easily understood language
    The coronavirus disease 2019 (COVID-19) is an acute respiratory disease caused by a novel coronavirus, that has been exported around the globe to reach pandemic proportion.
    La enfermedad por COVID-19 es una enfermedad respiratoria aguda causada por un nuevo coronavirus, que se ha exportado a todo el mundo hasta alcanzar una proporción pandémica.
    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
    The primary objective of the study is to determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.
    El objetivo principal del estudio es determinar la eficacia de ABX464 50 mg para prevenir la insuficiencia respiratoria o la muerte en los pacientes del estudio.
    E.2.2Secondary objectives of the trial
    Evaluate the proportion of patients requiring hospitalization compared to the {Standard of care + placebo} group
    Assess the proportion of patients reporting each severity rating on a 7-point ordinal scale
    Assess the time to an improvement of one category of the a 7-point on an ordinal scale from baseline
    Evaluate and compare the effect of ABX464 on immunophenotyping and cytokines levels
    Evaluate the proportion of patient requiring oxygen supplementation
    Assess the time to hospitalization
    Evaluate the time to application of invasive and non-invasive mechanical ventilation or high flow oxygen therapy
    Assess the IMV and/or NIV duration
    Assess the oxygen supplementation (>3L/min) duration
    Assess the hospital stay duration
    Evaluate the effect of ABX464 on miR-124 expression
    Assess the change in CRP, Troponin I & T and D-dimer levels
    Evaluate the prevention of Covid-19 related deaths
    Evaluate SARS-CoV-2 infection in subjects
    Evaluate the safety
    Evaluar:- porcentaje de pacientes que requieran hospitalización durante el estudio en comparación con el grupo de tratamiento habitual + placebo. -porcentaje de pacientes que presenten cada puntuación de severidad en una escala ordinal de 7 ptos.
    - tiempo hasta una mejoría de una categoría en una escala ordinal de 7 ptos. frente al momento basal. -evaluar y comparar el efecto en el inmunofenotipo y niveles de citocinas. - porcentaje de pacientes que requieran oxigenoterapia. - tiempo hasta la hospitalización.- tiempo de aplicación de ventilación mecánica invasiva (IMV) y no invasiva (NIV) u oxígeno de alto flujo. - la duración de la IMV y/o la NIV. - la duración de la oxigenoterapia (>3 l/min). - la duración de la estancia hospitalaria. - el efecto del ABX464 sobre la expresión de miR-124 .- el cambio a lo largo del tiempo de los niveles de proteína C-reactiva (CRP), troponina I y T y dímero D. - prevención muertes debidas a COVID-19.-la infección por SARS-CoV-2 .- la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
    1. Adult (>/= 18 years old) men or women hospitalizedor not hospitalized, diagnosed
    for SARS-CoV-2 infection by PCR with at least one associated risk factor. Considered risk factors are:
    • Age >/= 65 years
    • Obesity defined as BMI >/= 30
    • Recent histroy of uncontrolled High Blood Pressure (SBP > 150 mm Hg & DBP >100 mm Hg) according to investigator
    • Treated diabetes (type I or II)
    • History of ischemic cardiovascular disease
    2. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature >/= 37.8 °C oral/tympanic, or >/= 38.2 °C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.
    3. Patients with pulse oximetry arterial saturation (SpO2) >/= 92 % on room air at
    4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to D0:
    • Hemoglobin > 9.0 g dL-1
    • Absolute Neutrophil Count >/= 1000 mm-3;
    • Platelets >/= 100,000 mm-3;
    • Creatinine clearance >/= 50 mL min-1 by the Cockcroft-Gault formula
    • Total serum bilirubin < 2 x ULN
    • Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
    5. Women of child bearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is
    considered of childbearing potential (WOCBP), i.e. fertile, following menarche
    and until becoming post-menopausal unless permanently sterile. Permanent
    sterilisation methods include hysterectomy, bilateral salpingectomy and
    bilateral oophorectomy. A postmenopausal state is defined as no menses for
    12 months without an alternative medical cause. A high follicle stimulating
    hormone (FSH) level in the postmenopausal range may be used to confirm a
    post-menopausal state in women not using hormonal contraception or
    hormonal replacement therapy. However, in the absence of 12 months of
    amenorrhea, a single FSH measurement is insufficient. Finally a man is
    considered fertile after puberty unless permanently sterile by bilateral
    6. Patients must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
    7. Patients able and willing to comply with study visits and procedures as per protocol.
    8. Patients should be affiliated to a social security regimen (for French sites only).
    Podrán participar en este estudio los pacientes que cumplan TODOS los criterios siguientes:
    1. Varones o mujeres adultos (>/= 18 años), hospitalizados o no, con infección por SARS-CoV-2 diagnosticada por PCR, con como mínimo un factor de riesgo asociado. Se consideran factores de riesgo los siguientes:
    ·Edad >/= 65 años
    ·Obesidad, definida como un índice de masa corporal (BMI) >/= 30
    ·Antecedentes recientes de hipertensión arterial (sistólica > 150 mmHg y diastólica > 100 mmHg) no controlada a juicio del investigador
    ·Diabetes (de tipo I o II) tratada
    ·Antecedentes de enfermedad cardiovascular isquémica
    2.Pacientes sintomáticos en el momento de reclutamiento. Los síntomas se definen como fiebre (temperatura corporal oral/timpánica >/= 37,8 °C o rectal >/= 38,2 °C) durante más de 24 horas, acompañada de cefalea, dolor de garganta, tos seca, cansancio, dolor torácico o sensación de ahogo (sin dificultad respiratoria), mialgia, anosmia o ageusia.
    3.Pacientes con saturación arterial (SpO2) >/= 92% determinada mediante pulsioximetría con aire ambiental en el momento de reclutamiento.
    4.Pacientes con los siguientes parámetros hematológicos y bioquímicos obtenidos en el plazo de los 7 días previos al D0:
    ·Hemoglobina > 9,0 g dl-1
    ·Cifra absoluta de neutrófilos >/= 1000 mm-3
    ·Plaquetas >/= 100.000 mm-3
    ·Aclaramiento de creatinina >/= 50 ml min-1 según la ecuación de Cockcroft-Gault
    ·Bilirrubina sérica total < 2 x límite superior de la normalidad (ULN)
    ·Fosfatasa alcalina < 2 x ULN, AST (SGOT) y ALT (SGPT) < 3 x ULN
    5.Las mujeres potencialmente fértiles y los hombres que reciban el tratamiento del estudio y sus parejas deben aceptar el uso de un método anticonceptivo de gran efectividad durante el estudio y los 6 meses (180 días) siguientes al final del estudio o la terminación anticipada. La anticoncepción debe haberse iniciado como mínimo 2 semanas antes del reclutamiento. Las mujeres deben haber sido esterilizadas quirúrgicamente o, si son potencialmente fértiles, deben emplear un método anticonceptivo de gran efectividad. Las mujeres potencialmente fértiles entrarán en el estudio después de un periodo menstrual confirmado y una prueba de embarazo negativa. Son métodos anticonceptivos de gran efectividad la abstinencia verdadera, el dispositivo intrauterino (DIU) o la anticoncepción hormonal para inhibición de la ovulación, el sistema intrauterino de liberación de hormonas, la ligadura de trompas bilateral y la pareja vasectomizada. La abstinencia verdadera es aceptable si concuerda con el estilo de vida preferido y habitual del paciente. Siempre que se retrase el periodo menstrual (más de un mes entre menstruaciones), deberá confirmarse la ausencia de embarazo. Esta recomendación también se aplica a las mujeres potencialmente fértiles con ciclos menstruales infrecuentes o irregulares. Los pacientes, varones o mujeres, no deben tener planeado un embarazo durante el estudio y hasta 6 meses después de finalizar su participación en el estudio. Además, los varones deben usar preservativos durante el estudio y los 6 meses (180 días) siguientes a la finalización de su participación en el estudio. Los varones no deben donar semen mientras se precise anticoncepción. A los efectos de este protocolo, se considera que una mujer es potencialmente fértil, es decir, capaz de procrear, desde pasada la menarquia y hasta pasada la menopausia, salvo en caso de esterilidad permanente. Los métodos de esterilización permanente son: histerectomía, salpingectomía bilateral y ooforectomía bilateral. El estado posmenopáusico se define como la ausencia de menstruación durante 12 meses sin otra causa médica. En las mujeres que no empleen anticoncepción hormonal ni reciban tratamiento hormonal sustitutivo, se podrá confirmar el estado de posmenopausia mediante una concentración de hormona foliculoestimulante (FSH) en el rango posmenopáusico. Sin embargo, en ausencia de 12 meses de amenorrea, no es suficiente una sola determinación de FSH. Por último, se considera que un varón es fértil desde pasada la pubertad, salvo en caso de esterilidad permanente por orquiectomía bilateral.
    6.Pacientes que comprendan, firmen y fechen voluntariamente el documento de consentimiento informado por escrito en la visita antes de cualquier procedimiento específico del protocolo.
    7.Pacientes capaces y dispuestos a cumplir lo señalado en el protocolo respecto a las visitas y los procedimientos del estudio.
    8.Pacientes afiliados a la seguridad social (solo en los centros franceses).
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    1.Patients with moderate or severe acute respiratory failure or requiring non-invasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate >/= 30 breaths/min).
    2. Patients treated with immunosuppressors and/or immunomodulators (cf.
    Appendix 2).
    3. Engrafted patients (organ and/or hematopoietic stem cells).
    4. Patients with uncontrolled auto-immune disease.
    5. Patients with known or suspected active (i.e. not controlled) bacterial, viral
    (excluding COVID-19) or fungal infections.
    6. Patients with preexisting, severe and not controlled organ failure.
    7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
    8. Pregnant or breast-feeding women.
    9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
    10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
    11. Hypersensitivity to ABX464 and/or its excipients.
    12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    No podrán participar en el estudio los paciente que cumplan cualquiera de los siguientes criterios de exclusión:
    1.Pacientes con insuficiencia respiratoria aguda moderada o severa o que requieran ventilación no invasiva u oxígeno o con SpO2 < 92% o taquipnea (frecuencia respiratoria >/= 30 respiraciones/min).
    2.Pacientes tratados con inmunosupresores y/o inmunomoduladores (véase el Apéndice 2).
    3.Pacientes sometidos a trasplante (de órgano y/o de células madre hematopoyéticas).
    4.Pacientes con enfermedad autoinmunitaria no controlada.
    5.Pacientes con diagnóstico confirmado o de sospecha de infecciones bacterianas, víricas (excepto COVID-19) o micóticas activas (es decir, no controladas).
    6.Pacientes con insuficiencia orgánica preexistente, severa y no controlada.
    7.Antecedentes de cáncer o presencia de neoplasia maligna activa que requiera quimioterapia o radioterapia (excluidos los pacientes con como mínimo 2 años sin enfermedad).
    8.Mujeres embarazadas o en periodo de lactancia.
    9.Alcoholismo o drogodependencia que comprometa la seguridad del paciente o el cumplimiento del protocolo del estudio.
    10.Uso de cualquier producto en investigación o no registrado en el plazo de los 3 meses o 5 semividas del producto anteriores al momento basal, eligiéndose el más prolongado.
    11.Hipersensibilidad al ABX464 y/o a sus excipientes.
    12.Enfermedad o situación que, en opinión del investigador, pudiera comprometer la seguridad del paciente o el cumplimiento del protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive at the end of the 28 days period.
    Porcentaje de pacientes que no precisen oxigenoterapia o ventilación mecánica no invasiva (IMV y NIV, respectivamente) y que permanezcan con vida al final del periodo de 28 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    E.5.2Secondary end point(s)
    1.Rate of patients hospitalized in both treatment groups
    2. Percentage of patients reporting each severity rating on a 7-point ordinal scale at each study visit (i.e. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death);
    3.Mean change in the ranking on an ordinal scale from baseline to days 7, 14, 21, and 28
    4.Change from enrolment in inflammatory markers in plasma (i.e. MCP-1, MIP-1 alpha, G-CSF, IL-1b, IL-2, IL-6, IL-7, IL-10, IL-17, INFg and TNFa) and in immune phenotype and assessment of cell-activation markers in PBMCs at D14, D28 for hospitalized patients only.
    5.Rate of patients requiring oxygen supplementation in both treatment groups.
    6.Time to hospitalization (log rank) from baseline in both treatment groups.
    7.Time to assisted ventilation and oxygen supplementation (log rank) from baseline in both treatment groups.
    8.Number of days of assisted ventilation in both treatment groups.
    9.Number of days of oxygen supplementation in both treatment groups.
    10.Number of days at the hospital from admission to discharge in both treatment groups.
    11.Change from baseline in microRNA-124 levels in total blood (PAXgene®) at D0, D7 and D28 in both treatment groups.
    12.AUC and % of change from enrolment in CRP, Troponin I & T and D-dimer levels in both treatment groups.
    13.Time to death (log rank) and mortality rate (all causes, and Covid-19 related) in both treatment groups.
    14.SARS-CoV-2 virus in nasopharyngeal sample and/or in blood at Day 0, 7, 14, 21, and 28.
    15.Number and rates of participants with Treatment Emergent Adverse Event
    16.Cumulative incidence of serious adverse events (SAEs) - 28 days
    17.Cumulative incidence of Grade 3 and 4 adverse events (AEs) - 28 days
    18.Number of participants with a discontinuation or temporary suspension of study drugs (for any reason) - 28 days.
    19.Central blinded review of the hospitalization discharge CT-Scans for descriptive analysis with regards to the disease severity and outcomes.
    1. Procentage de pacientes hospitalizados en ambos grupos.
    2. Porcentaje de pacientes que presenten cada puntuación de severidad en una escala ordinal de 7 puntos en cada visita del estudio (a saber, no hospitalizados, sin limitaciones en las actividades; no hospitalizados, limitación de actividades; hospitalizados, sin necesidad de oxigenoterapia; hospitalizados, con necesidad de oxigenoterapia; hospitalizados, con ventilación no invasiva u oxígeno de alto flujo; hospitalizado, con ventilación mecánica invasiva o membrana de oxigenación extracorpórea [ECMO]; fallecido).
    3. Cambio medio de la clasificación en una escala ordinal entre el momento basal y los días 7, 14, 21 y 28.
    4. Cambio de los marcadores inflamatorios en plasma (es decir, MCP-1, MIP-1 alfa, G-CSF, IL-1b, IL-2, IL-6, IL-7, IL-10, IL-17, INFg y TNFa) y el inmunofenotipo y la evaluación de los marcadores de activación celular en leucocitos mononucleares periféricos el D14 y el D28 frente al momento de reclutamiento (solo en pacientes hospitalizados).
    5. Porcentaje de pacientes que requieran oxigenoterapia en ambos grupos de tratamiento.
    6. Tiempo hasta la hospitalización (rango logarítmico) desde el momento basal en ambos grupos de tratamiento.
    7. Tiempo hasta la hospitalización (rango logarítmico) desde el momento basal en ambos grupos de tratamiento.
    8. Número de días de ventilación asistida en ambos grupos de tratamiento.
    9. Número de días de oxigenoterapia en ambos grupos de tratamiento.
    10. Número de días en el hospital desde el ingreso hasta el alta en ambos grupos de tratamiento.
    11. Cambio de los niveles de microARN-124 en sangre total (PAXgene®) los días D0, D7 y D28 frente al momento basal en ambos grupos de tratamiento
    12. AUC y cambio porcentual de los niveles de proteína C-reactiva, troponina I y T y dímero D frente al momento de reclutamiento en ambos grupos de tratamiento.
    13. Tiempo hasta el fallecimiento (rango logarítmico) y tasa de mortalidad (por cualquier causa y por la COVID-19) en ambos grupos de tratamiento.
    14. s SARS-CoV-2 en muestra nasofaríngea y/o en sangre los Días 0, 7 (pacientes hospitalizados), 14, 21 y 28.
    15. Número y porcentaje de participantes con acontecimientos adversos surgidos en el tratamiento
    16. Incidencia acumulada de acontecimientos adversos graves (serious adverse events, SAE) - 28 días
    17. Incidencia acumulada de acontecimientos adversos (adverse events, AE) de grados 3 y 4 - 28 días
    18. Número de participantes con suspensión temporal o permanente de los medicamentos del estudio (por cualquier motivo) - 28 días.
    19. Revisión central, sin conocimiento del tratamiento, de las tomografías computarizadas del alta hospitalaria a fines de análisis descriptivo sobre la severidad de la enfermedad y los resultados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the course of the study
    2. During the course of the study
    3. Days 7, 14, 21 and 28 from baseline
    4. Days 14 and 28
    5. During the course of the study
    6. During the course of the study
    7. During the course of the study
    8. During the course of the study
    9. During the course of the study
    10. During the course of the study
    11. Days 0, 7 and 28
    12. During the course of the study
    13. During the course of the study
    14. Days 0, 7, 14, 21 and 28
    15. During the course of the study
    16. Day 28
    17. Day 28
    18. Day 28
    19. During the course of the study
    1. Durante el estudio
    2. Durante el estudio
    3. Entre el momento basal y los días 7, 14, 21 y 28
    4. Días 14 y 28.
    5. Durante el estudio
    6. Durante el estudio
    7. Durante el estudio
    8. Durante el estudio
    9. Durante el estudio
    10. Durante el estudio
    11. Días 0, 7 y 28.
    12. Durante el estudio
    13. Durante el estudio
    14. Días 0, 7, 14 y 28
    15. Durante el estudio
    16. Día 28
    17. Día 28
    18. Día 28
    19. Durante el estudio
    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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    The study will end once all the recruited patients have performed their safety follow-up and the End of Study visit, and all the data have been analyzed and computed in the clinical study report (CSR).
    El estudio finalizará una vez que todos los pacientes reclutados se hayan sometido al seguimiento de seguridad y hayan realizado la visita de fin del estudio, y todos los datos hayan sido analizados y contabilizados en el informe del estudio clínico (clinical study report, CSR).
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 634
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state122
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1034
    F.4.2.2In the whole clinical trial 1034
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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