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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001338-21
    Sponsor's Protocol Code Number:I4V-MC-KHAB
    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:2021-08-23
    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 number2021-001338-21
    A.3Full title of the trial
    A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized with
    COVID-19
    Estudio multicéntrico, sin enmascaramiento, en el que se evalúa la farmacocinética y la seguridad de baricitinib en pacientes pediátricos (desde 1 año hasta menos de 18 años de edad) hospitalizados con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Baricitinib in Children With COVID-19 (COV-BARRIER-PEDS)
    Un estudio de baricitinib en niños con COVID-19 (COV-BARRIER-PEDS)
    A.3.2Name or abbreviated title of the trial where available
    COV-BARRIER-PEDS
    COV-BARRIER-PEDS
    A.4.1Sponsor's protocol code numberI4V-MC-KHAB
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/062/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Cork Ltd
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Park, Little Island
    B.5.3.2Town/ cityCo. Cork
    B.5.3.3Post codeT45 KD39
    B.5.3.4CountryIreland
    B.5.4Telephone number34918362958
    B.5.6E-mailensayosclinicos@lilly.com
    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.3.1Product nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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 infection
    Infección por COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infección por 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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetics (PK) of baricitinib in pediatric patients with COVID-19
    Caracterizar la farmacocinética (FC) de baricitinib en pacientes pediátricos con COVID-19
    E.2.2Secondary objectives of the trial
    - To describe the safety of baricitinib in pediatric patients with COVID-19
    - To describe the effect of baricitinib on COVID-19 progression in pediatric patients
    - To describe clinical outcomes in pediatric patients with COVID-19 treated with baricitinib
    - Describir la seguridad de baricitinib en pacientes pediátricos con COVID-19
    - Describir el efecto de baricitinib desde el punto de vista de la progresión de la COVID-19 en pacientes pediátricos
    - Describir los desenlaces clínicos en pacientes pediátricos con COVID-19 tratados con baricitinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients from 1 to <18 years of age at the time of enrollment
    - Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by NAAT or immunodiagnostic tests, with a positive result in a sample collected no more than 14 days prior to treatment assignment
    - Require supplmental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment
    - Pacientes de ambos sexos que en el momento del reclutamiento tengan entre 1 y <18 años
    - Hospitalizados con infección por el coronavirus SARS-CoV-2, confirmada mediante NAAT o pruebas inmunodiagnósticas, con un resultado positivo en una muestra recogida como máximo 14 días antes de la asignación del tratamiento
    - Que requieran oxigenoterapia y presenten hallazgos en las pruebas de imagen torácicas que confirmen la presencia de enfermedad respiratoria por COVID-19 en el transcurso de las 72 horas anteriores a la inclusión y el reclutamiento en el estudio
    E.4Principal exclusion criteria
    - Are receiving biologic treatments (such as TNF inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferons, or JAK inhibitors) for any indication at study entry; or are receiving other immunosuppressants such that, in the opinion of the investigator, participating in the study would put the participant at an unacceptable risk of immunosuppression. Note: A washout period is required prior to screening.
    - Are receiving strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
    - Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required)
    - Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
    - Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: use of nonlive (inactivated) vaccinations is allowed for all participants
    - Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry
    - Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product
    - Have any history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or are considered at high risk of VTE (DVT/PE) by the investigator
    - Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry
    - Have neutropenia (absolute neutrophil count < 1000 cells/microliters)
    - Have lymphopenia (absolute lymphocyte count < 200 cells/microliters)
    - Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times AAULN
    - Estimated glomerular filtration rate (eGFR) <40 milliliter/minute/1.73 meters squared
    - Que estén recibiendo tratamientos biológicos (como inhibidores del TNF, inhibidores de las interleucinas, tratamientos dirigidos con linfocitos T o linfocitos B, interferones o inhibidores de las JAK) para cualquier indicación en el momento de inclusión en el estudio; o que estén recibiendo otros inmunodepresores de tal forma que, según el criterio del investigador, la participación en el estudio supondría para el participante un riesgo inaceptable de inmunodepresión. Nota: Antes de la selección debe instaurarse un período de reposo farmacológico.
    - Que estén recibiendo inhibidores potentes del OAT3 (como probenecid) cuya administración no pueda interrumpirse en el momento de inclusión en el estudio.
    - Que presenten en la actualidad diagnóstico de tuberculosis (TB) activa o, si se sabe, TB latente tratada durante menos de 4 semanas con un tratamiento adecuado para la tuberculosis de acuerdo con las directrices locales (solo de conformidad con la historia clínica, no es necesario realizar pruebas de cribado)
    - Sospecha de infección bacteriana, fúngica, vírica o de otro tipo (aparte de la COVID-19) activa y grave que, en opinión del investigador, podrían constituir un riesgo en caso de tomar el producto en fase de investigación
    - Que hayan recibido cualquier vacuna elaborada con microbios vivos en el transcurso de las 4 semanas anteriores a la selección, o que tengan previsto recibir una vacuna elaborada con microbios vivos durante el estudio Nota: se permite que los pacientes reciban vacunas que no estén elaboradas con microbios vivos (inactivadas)
    - Que en el momento de la inclusión en el estudio requieran ventilación mecánica invasiva, incluida la oxigenación por membrana extracorporal (OMEC)
    - Que en la actualidad presenten diagnóstico de una neoplasia maligna activa que, en opinión del investigador, podrían constituir un riesgo en caso de tomar el producto en fase de investigación
    - Que presenten antecedentes de tromboembolia venosa (TEV) (trombosis venosa profunda [TVP] y/o embolia pulmonar [EP]) o que el investigador considere que presenten riesgo alto de TEV (TVP/EP)
    - Que se prevea que se les vaya a dar el alta hospitalaria o transferirlos a otro hospital (o unidad) que no sea un centro del estudio en el transcurso de las 72 horas posteriores a la inclusión en el estudio
    - Que presenten neutrocitopenia (recuento absoluto de neutrófilos <1000 células/microlitro)
    - Que presenten linfocitopenia (recuento absoluto de linfocitos <200 células/microlitro)
    - Concentración de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >5 veces el límite superior de la normalidad ajustado en función de la edad (LSNAE)
    - Filtración glomerular estimada (FGe) <40 mililitros/minuto/1,73 m2
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic parameters, including AUC and Cmax of baricitinib, in pediatric patients with COVID-19
    Parámetros farmacocinéticos, incluidos el área bajo la curva (ABC) y la Cmáx de baricitinib en pacientes pediátricos con COVID-19
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 and day 4
    Día 1 y día 4
    E.5.2Secondary end point(s)
    1. Safety assessments, including AEs and laboratory abnormalities
    2. Proportion of patients who require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) by Day 28
    3. Proportion of patients who die or require noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) by Day 28
    4. Proportion of patients with at least 1-point improvement on NIAID-OS or live discharge from hospital at Day 4, Day 7, Day 10, Day 14, and Day 28
    5. Number of ventilator-free days (Day 1 to Day 28)
    6. Time to recovery on the NIAID-OS (Day 1 to Day 28)
    7. Overall improvement on the NIAID-OS evaluated at Day 4, Day 7, Day 10, Day 14, and Day 28
    8. Duration of hospitalization (Day 1 to Day 28)
    9. All-cause mortality (Day 1 to Day 28 and Day 60)
    10. Duration of stay in the intensive care unit (ICU) in days (Day 1 to Day 28)
    1. Evaluaciones de la seguridad, incluidos los AA y los valores anómalos en las pruebas analíticas
    2. Proporción de pacientes que requieran ventilación no invasiva / oxigenoterapia de alto flujo o ventilación mecánica invasiva (incluida la OMEC) el día 28
    3. Proporción de pacientes que fallezcan o requieran ventilación no invasiva / oxigenoterapia de alto flujo o ventilación mecánica invasiva (incluida la OMEC) el día 28
    4. Proporción de pacientes con una mejoría mínima de 1 punto en la NIAID-OS o que estén vivos en el momento del alta hospitalaria el día 4, el día 7, el día 10, el día 14 y el día 28
    5. Número de días sin respirador (desde el día 1 hasta el día 28)
    6. Tiempo transcurrido hasta la recuperación de acuerdo con la NIAID-OS (desde el día 1 hasta el día 28)
    7. Mejoría global de acuerdo con la NIAID-OS evaluada los días 4, 7, 10, 14 y 28
    8. Duración de la hospitalización (desde el día 1 hasta el día 28)
    9. Mortalidad por cualquier causa (desde el día 1 hasta el día 28 y hasta el día 60)
    10. Duración de la hospitalización en la unidad de cuidados intensivos (UCI) en días (desde el día 1 hasta el día 28)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated (Day 1 to Day 28), except: endpoint number 9 (Day 1 to Day 28 and Day 60)
    Se evaluarán todos los criterios secundarios de valoración (desde el día 1 hasta el día 28), salvo el criterio de valoración número 9 (desde el día 1 hasta el día 28 y hasta el día 60)
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Mexico
    United States
    Belgium
    Italy
    Netherlands
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 Yes
    F.1.1Number of subjects for this age range: 24
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric population
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 24
    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
    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 Decision2021-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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