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    Summary
    EudraCT Number:2020-001517-21
    Sponsor's Protocol Code Number:I4V-MC-KHAA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-22
    Trial results View 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 number2020-001517-21
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection
    Estudio fase 3, aleatorizado, doble ciego, comparado con placebo y de grupos paralelos, en el que se evalúa baricitinib en pacientes con infección por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Baricitinib in Patients with COVID-19 Infection
    Baricitinib en pacientes con infección por COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COV-BARRIER
    COV-BARRIER
    A.4.1Sponsor's protocol code numberI4V-MC-KHAA
    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 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.5.6E-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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, the Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboFilm-coated tablet
    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
    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 evaluate the effect of baricitinib 4 mg once daily (QD) compared to placebo on disease progression in patients with COVID-19 infection
    Comparar el efecto de baricitinib 4 mg una vez al día (1 v/d) con el de un placebo en pacientes con infección por COVID-19, desde el punto de vista de progresión de la enfermedad
    E.2.2Secondary objectives of the trial
    To evaluate the effect of baricitinib 4 mg QD compared to placebo on clinical outcomes in patients with COVID-19 infection
    Comparar el efecto de baricitinib 4 mg 1 v/d con el de un placebo en pacientes con infección por COVID-19, desde el punto de vista de los desenlaces clínicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:
    • PCR positive in sample collected <72 hours prior to randomization; OR
    • PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
    - Have evidence of pneumonia (SpO2 <94 or PaO2/FiO2 [or SpO2/FiO2] ratio <300 mmHg or chest imaging findings consistent with pneumonia), OR have evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/minute).
    - Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.
    - Hospitalización por infección por el coronavirus (SARS-CoV-2), confirmada mediante una prueba de la reacción en cadena de la polimerasa (PCR) u otros ensayos comercializados o de la sanidad pública con cualquier muestra, y documentada de alguna las siguientes maneras:
    • Resultado positivo en una PCR con una muestra recogida <72 horas antes de la aleatorización; O
    • Resultado positivo en una PCR con una muestra recogida ≥72 horas antes de la aleatorización (aunque no más de 14 días antes de la aleatorización), imposibilidad documentada de obtener otra muestra (por ejemplo, por falta de suministros o capacidad limitada para realizar las pruebas, por que se tarde más de 24 horas en obtener los resultados, etc.) Y progresión de la enfermedad indicativa de infección en curso por el SARS-CoV-2.
    - Presentar indicios de neumonía (SpO2 <94 o relación PaO2/FiO2 [o SpO2/FiO2] <300 mmHg o hallazgos en las pruebas de imagen del tórax compatibles con neumonía), O indicios de infección activa por COVID (con, entre otros, alguno de los siguientes síntomas clínicos: fiebre, vómitos, diarrea, tos seca y taquipnea [frecuencia respiratoria >24 respiraciones/minuto]).
    - Presentar indicadores de riesgo de progresión: al menos 1 marcador de inflamación por encima del límite superior de la normalidad (LSN) (proteína C-reactiva [CRP], dímero D, lactato deshidrogenasa [LDH], ferritina), con al menos 1 elevación >LSN en el transcurso de los 2 días anteriores a la inclusión en el estudio.
    E.4Principal exclusion criteria
    - Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
    - Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
    - Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for >=14 consecutive days in the month prior to study entry.
    - 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 a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
    - 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 ULN
    - Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
    - Have a known hypersensitivity to baricitinib or any of its excipients.
    - Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study.
    Note: The participant should not be enrolled (start) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
    - Are pregnant, or intend to become pregnant or breastfeed during the study.
    - Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
    - Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
    - Estar recibiendo tratamientos citotóxicos o biológicos (como inhibidores del factor de necrosis tumoral [TNF], anti-interleucina-1 [IL-1], anti-IL-6 [tocilizumab o sarilumab], tratamientos dirigidos a los linfocitos T o B (rituximab), interferón o inhibidores de las janocinasas (JAK) para cualquier indicación en el momento de inclusión en el estudio. Nota: Antes de la selección, el paciente debe someterse a un período de reposo farmacológico de 4 semanas (o de 5 semividas, lo que sea mayor).
    - Haber recibido durante la convalecencia plasma o inmunoglobulinas (IVIg) por vía intravenosa para tratar la COVID-19.
    - Haber recibido corticoesteroides en dosis altas (>20 mg/día [o equivalente de prednisona]) durante ≥14 días consecutivos en el mes anterior a la inclusión en el estudio.
    - Estar recibiendo inhibidores potentes del OAT3 (como probenecid) cuya administración no pueda interrumpirse en el momento de la inclusión en el estudio.
    - Presentar en la actualidad diagnóstico de tuberculosis (TB) activa, o TB latente que se haya tratado durante menos de 4 semanas con un tratamiento antituberculoso adecuado de acuerdo con las guías locales (según se documente en la historia clínica; no es necesario realizar cribado).
    - Sospecha de infecciones bacterianas, fúngicas, víricas o de otro tipo (aparte del COVID-19) activas y graves que, en opinión del investigador, podría constituir un riesgo si se tomara el producto en investigación.
    - Haber recibido una vacuna elaborada con microbios vivos en el transcurso de las 4 semanas anteriores a la selección, o tener previsto recibir una vacuna de este tipo durante el estudio. Nota: Los participantes pueden recibir vacunas sin microbios vivos (inactivadas).
    - Requerir en el momento de inclusión en el estudio ventilación mecánica invasiva, incluida la oxigenación por membrana extracorpórea (ECMO).
    - Presentar en la actualidad diagnóstico de una neoplasia maligna activa que, en opinión del investigador, podría constituir un riesgo si se tomara el producto en investigación.
    - Antecedentes de tromboembolia venosa (TEV) (trombosis venosa profunda [TVP] y embolia pulmonar [EP]) en el transcurso de las 12 semanas anteriores a la aleatorización, o antecedentes de TEV (TVP/EP) recurrente (>1).
    - Previsión de alta hospitalaria del paciente o de transferencia a otro hospital (u otra unidad) que no sea un centro del estudio en el transcurso de las 72 horas posteriores a la inclusión en el estudio.
    - Presentar neutrocitopenia (cifra absoluta de neutrófilos <1000 células/microlitro).
    - Presentar linfocitopenia (cifra absoluta de linfocitos <200 células/microlitro).
    - Concentración de alanina aminotransferasa (ALT) o de aspartato aminotransferasa (AST) >5 veces el LSN.
    - Filtración glomerular estimada (FGe) (Modification of Diet in Renal Disease [MDRD]) <30 mililitros/minuto/1,73 metros cuadrados.
    - Presentar hipersensibilidad a baricitinib o a sus excipientes.
    - Participar en la actualidad en cualquier otro ensayo clínico en el que se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica que se considere que no es compatible con el estudio, desde un punto de vista científico o médico.
    Nota: El participante no debe participar en otro estudio clínico (comenzarlo) para el tratamiento de la COVID-19 o del SARS CoV-2 en el período hasta el día 28.
    - Mujeres que estén embarazadas o deseen quedarse embarazadas o dar el pecho durante el estudio.
    - Estar utilizando o tener previsto utilizar un dispositivo extracorpóreo de depuración de la sangre (DEDS) para eliminar las citocinas proinflamatorias de la sangre, como un dispositivo de absorción o filtración de citocinas (por ejemplo, CytoSorb®).
    - Que, en opinión del investigador, sea improbable que el paciente sobreviva al menos durante las 48 horas posteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO]).
    Porcentaje de participantes que fallezcan o requieran ventilación no invasiva/oxigenoterapia de alto flujo o ventilación mecánica invasiva (incluida la oxigenación por membrana extracorpórea [ECMO]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 28
    Del día 1 al día 28
    E.5.2Secondary end point(s)
    1.Percentage of Participants with at Least 1-Point Improvement on NIAID-OS or Live Discharge from Hospital. The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
    2.Number of Ventilator-Free Days
    3.Time to Recovery (Recovery assessed by the NIAID-OS)
    4.Overall Improvement on the NIAID-OS
    5.Duration of Hospitalization
    6.Percentage of Participants with a Change in Oxygen Saturation from <94% to ≥94% from Baseline
    7.Mortality
    8.Duration of Stay in the Intensive Care Unit (ICU) in Days
    9.Time to Clinical Deterioration (one-category increase on the NIAID-OS)
    10.Time to Resolution of Fever, in Participants with Fever at Baseline
    11. Mean Change from Baseline on the National Early Warning Score (NEWS). The NEWS is used to detect and report changes in illness severity in participants with acute illness. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness
    12.Time to Definitive Extubation
    13.Time to Independence from Non-Invasive Mechanical Ventilation
    14.Time to Independence from Oxygen Therapy in Days
    15.Number of Days with Supplemental Oxygen Use
    16.Number of Days of Resting Respiratory Rate <24 Breaths per Minute
    1. Porcentaje de participantes con una mejoría de al menos 1 punto en la escala NIAID-OS o a los que se les dé el alta hospitalaria sin haber fallecido La escala ordinal del National Institute of Allergy and Infectious Diseases (NIAID-OS) es una evaluación del estado clínico. La escala consta de los siguientes parámetros: muerte; hospitalizado, con ventilación mecánica invasiva u oxigenación por membrana extracorpórea (ECMO); hospitalizado, con ventilación no invasiva o dispositivos de oxígeno de alto flujo; hospitalizado, requiere oxígeno suplementario; hospitalizado, no requiere oxígeno suplementario - requiere atención médica continua (por la COVID-19 o por otras razones); hospitalizado, no requiere oxígeno suplementario - ya no requiere atención médica continua; no hospitalizado, limitación de las actividades y/o requiere oxígeno en su domicilio; no hospitalizado, sin limitaciones de las actividades.
    2. Número de días sin ventilación
    3. Tiempo transcurrido hasta la recuperación (la recuperación se evaluará de acuerdo con la escala NIAID-OS)
    4. Mejoría global de acuerdo con la escala NIAID-OS.
    5. Duración de la hospitalización.
    6. Porcentaje de participantes con una variación en la saturación de oxígeno desde <94 % a ≥94 % respecto al período inicial.
    7. Mortalidad.
    8. Duración (días) de la hospitalización en la unidad de cuidados intensivos (ICU).
    9. Tiempo transcurrido hasta el deterioro clínico (aumento de una categoría en la escala NIAID-OS).
    10. Tiempo transcurrido hasta la resolución de la fiebre en los participantes que presentaran fiebre durante el período inicial.
    11. Media de la variación respecto al período inicial en la puntuación de alerta temprana a nivel nacional (NEWS). La puntuación NEWS se utiliza para identificar y notificar cambios en la intensidad de la enfermedad de participantes con enfermedades agudas. La puntuación se determina a partir de seis parámetros fisiológicos que pueden medirse fácilmente a lo largo del tiempo en los participantes hospitalizados: frecuencia respiratoria, saturación de oxígeno, temperatura, tensión arterial sistólica, frecuencia cardíaca (pulso) y grado de conciencia.
    12. Tiempo transcurrido hasta la extubación definitiva.
    13. Tiempo transcurrido hasta la independencia de la ventilación mecánica no invasiva.
    14. Tiempo transcurrido (días) hasta la independencia de la oxigenoterapia.
    15. Número de días durante los cuales se ha recibido oxígeno suplementario.
    16. Número de días en los que la frecuencia respiratoria en reposo se ha situado por debajo de 24 respiraciones por minuto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated [Day 1 to Day 28], except: endpoint 1 and 6 [Day 10], endpoint 11 [Baseline, Day 1 to Day 28].
    Se evaluarán todos los criterios secundarios de valoración [del día al día 28], salvo: los criterios de valoración 1 y 6 [día 10], el criterio de valoración 11 [período inicial; del día 1 al 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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Argentina
    Brazil
    Germany
    Italy
    Mexico
    Russian Federation
    Spain
    United Kingdom
    United States
    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
    Última 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 months4
    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 months4
    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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to the severity of the patient’s disease state subjects, limited to patients that may be too sick or confused.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 423
    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)
    Baricitinib will not be provided to participants following completion of the study.
    Baricitinib no se proporcionará a los participantes tras la finalización del estudio.
    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 Decision2020-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-10
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