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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2020-001759-42
    Sponsor's Protocol Code Number:214094
    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:2020-05-31
    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 number2020-001759-42
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease.
    Estudio aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de otilimab intravenoso en pacientes con enfermedad pulmonar grave asociada a COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating otilimab in patients with severe coronavirus related lung disease.
    Otilimab en pacientes con enfermedades pulmonares graves relacionadas con el coronavirus.
    A.3.2Name or abbreviated title of the trial where available
    OSCAR
    A.4.1Sponsor's protocol code number214094
    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 SponsorGlaxoSmithKline, 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 supportGlaxoSmithKline LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34 902202700
    B.5.5Fax number34 918070479
    B.5.6E-mailes-ci@gsk.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 nameotilimab
    D.3.2Product code GSK3196165
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOTILIMAB
    D.3.9.1CAS number 1638332-55-4
    D.3.9.2Current sponsor codeGSK3196165
    D.3.9.3Other descriptive nameAnti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
    D.3.9.4EV Substance CodeSUB198008
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe pulmonary COVID-19 related disease
    enfermedad pulmonar grave asociada a COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe coronavirus related lung disease
    enfermedad pulmonar grave asociada a coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of otilimab IV versus placebo.
    Comparar la eficacia de otilimab 90 mg IV frente a placebo.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of otilimab IV versus placebo.
    To compare the safety and tolerability of otilimab IV versus placebo.
    Comparar la eficacia de otilimab 90 mg IV frente a placebo.
    Comparar la seguridad y tolerabilidad de otilimab 90 mg IV frente a placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years and ≤79 years at the time of obtaining informed consent.
    2. Participants must:
    a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample])
    b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
    c. AND be developing new onset of oxygenation impairment defined as:
    - SpO2 ≤93% on room air
    - AND on high-flow oxygen (≥15L/min)
    - AND/OR non-invasive ventilation (NIV, CPAP OR BIPAP)
    - OR mechanical ventilation ≤48h prior to dose
    d. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN).
    3. No gender restriction.
    4. Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol.
    5. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed.
    1. Edad >18 años y <79 años de edad, en el momento de firmar el consentimiento informado.
    2. Participantes con:
    a. tener un resultado positivo de SARS-CoV-2 (cualquier prueba validada, por ejemplo, RT-PCR [realizada en un espécimen apropiado; p.ej. muestra del tracto respiratorio])
    b. Y ser hospitalizado debido a un diagnóstico de neumonía (radiografía de tórax o tomografía computarizada [TC] compatible con COVID-19)
    c. Y estar desarrollando un inicio de deterioro de la oxigenación. definido como:
    1. SpO2 <93% con aire ambiente
    2. Y aporte de oxígeno a alto flujo (> 4 L/min)
    3. Y / O ventilación no invasiva (NIV, CPAP o BiPAP)
    4. O ventilación mecánica < 48 h antes de la dosis
    d. Y presentar una elevación de los marcadores biológicos de la inflamación (o PCR > LSN1 o ferritina sérica >LSN1)
    3. No hay restricciones de género en el estudio.
    4. Las participantes femeninas deben cumplir y aceptar cumplir con los criterios anticonceptivos recogidos en el Apéndice 4. El uso de anticonceptivos por parte de las mujeres debe ser coherente con la normativa local sobre métodos anticonceptivos para participantes en estudios clínicos.
    Una mujer es elegible para participar si no está embarazada o en periodo de lactancia. Y se aplica, al menos, una de las siguientes condiciones:
    - No es una mujer en edad fértil (MEF), tal y como se define en la Sección 9.4 (Guía sobre Métodos Anticonceptivos validos en el protocolo).
    O
    - Es una MEF y utiliza un método anticonceptivo altamente eficaz, con una tasa de fracaso de <1% al año, como se describe en la Sección 9.4, durante el periodo terapéutico y, al menos, en los 60 días posteriores a la última dosis del tratamiento del estudio. Si no utiliza un método anticonceptivo altamente efectivo durante la hospitalización, la participante debe aceptar permanecer abstinente hasta al menos 60 días después de la última dosis de medicación del estudio. El investigador debería evaluar el potencial de fracaso del método anticonceptivo (por ejemplo, incumplimiento, recientemente iniciado) en relación con la primera dosis de intervención del estudio.
    - Una MEF debe tener una prueba de embarazo negativa altamente sensible (orina o suero según lo requerido por las regulaciones locales) al ingreso al hospital o antes de la primera dosis de la intervención del estudio. Consulte la Sección 7.3.5 Pruebas de embarazo (requisitos adicionales para las pruebas de embarazo durante y después del tratamiento del estudio).
    - El investigador es responsable de revisar el historial médico, los antecedentes menstruales y la actividad sexual reciente para reducir el riesgo de inclusión de una mujer con un embarazo no detectado precozmente.
    5. Con capacidad para otorgar el consentimiento informado firmado como se describe en la Sección 9.1.3. Si los sujetos no son capaces de otorgar el consentimiento informado por escrito, se seguirán procedimientos alternativos como se indica en la Sección 9.1.3.
    E.4Principal exclusion criteria
    1. Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
    2. Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
    3. Extracorporeal membrane oxygenation (ECMO) or haemofiltration/dialysis.
    4. Current serious or uncontrolled medical condition (e.g. significant pulmonary disease [such as severe COPD or pulmonary fibrosis], heart failure [NYHA class III or higher], significant renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
    5. Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
    6. Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
    7. Known HIV regardless of immunological status.
    8. Known HBsAg and/or anti-HCV positive.
    9. Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
    10. Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin or planned to be received during the study.
    11. Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (e.g. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study.
    12. History of allergic reaction, including anaphylaxis to any previous treatment with an anti- GM-CSF therapy.
    13. Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 mg or equivalent per day.
    14. Treatment with an investigational drug within 30 days of randomization.
    15. Participating in other drug clinical trials, including for COVID-19.
    16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x upper limit of normal (ULN)
    17. Platelets <50,000/mm3
    18. Hemoglobin ≤9 g/L
    19. Absolute neutrophil count (ANC) <1.5 x 109/L (neutropenia ≥ Grade 2)
    20. Estimated GFR ≤30 mL/min/1.73m2
    21. Pregnant or breastfeeding females.
    1. La progresión a la muerte es inminente e inevitable dentro de las siguientes 48 horas, independientemente de la administración de tratamientos, en opinión del investigador.
    2. Insuficiencia orgánica múltiple según el criterio del investigador o una puntuación de la escala de Evaluación de Fallo Orgánico Secuencial (puntuación SOFA, de sus siglas en inglés) > 10 si está en la UCI.
    3. Oxigenación por membrana de oxigenación extracorpórea (ECMO) o hemofiltración / diálisis.
    4. Condición médica actual grave o no controlada (p. Ej., Enfermedad pulmonar significativa [como EPOC grave o fibrosis pulmonar], insuficiencia cardíaca [NYHA clase III o superior], disfunción renal significativa, infarto agudo de miocardio o accidente cerebrovascular agudo en los últimos 3 meses) o anormalidad de las pruebas de laboratorio que, a juicio del investigador, impidan la participación segura del participante y la finalización del estudio.
    5. Infección sistémica bacteriana, fúngica, viral u otra, no tratada (que no sea SARS-CoV-2).
    6. Tuberculosis activa (TB) conocida, antecedentes de TB activa o latente no tratada o tratada de forma incompleta, TB extrapulmonar sospechada o conocida.
    7. VIH conocido independientemente del estado inmunológico.
    8. HBsAg conocido y / o anti-VHC positivo.
    9. Recibiendo en la actualidad radioterapia, quimioterapia o inmunoterapia como tratamiento oncológico.
    10. El sujeto ha recibido tratamiento con anticuerpos monoclonales (por ejemplo, tocilizumab, sarilumab) en los últimos 3 meses antes de la aleatorización, incluida inmunoglobulina intravenosa, o tiene planificado recibirlos durante el estudio.
    11. El sujeto ha recibido tratamiento con terapia inmunosupresora que incluye, entre otros, ciclosporina, azatioprina, tacrolimus, micofenolato, inhibidores de JAK (por ejemplo, baricitinib, tofacitinib, upadacitinib) en los últimos 3 meses antes de la aleatorización o tiene planificado recibirlos durante el estudio.
    12. Antecedentes conocidos de reacción alérgica, incluida la anafilaxia, a cualquier tratamiento previo con una terapia anti-GM-CSF.
    13. Recibiendo actualmente un tratamiento crónico con corticosteroides orales para una afección no relacionada con COVID-19 en una dosis superior a 10 mg de prednisona o equivalente por día.
    14. Tratamiento con un medicamento en investigación dentro de los 30 días de la aleatorización.
    15. Participando actualmente en otro ensayo clínico con medicamentos, incluido ensayos para COVID-19.
    16. Aspartato aminotransferasa (AST) o alanina aminotrasferasa (ALT) > 5 X limite superior de normalidad (LSN).
    17. Recuento de plaquetas <50.000/mm3
    18. Hemoglobina <9 g/L
    19. Recuento absoluto de neutrófilos (ANC) <1.5 x 109/L (neutropenia > grado 2).
    20. Tasa de filtración glomerular estimada (GFR) <30 ml/min/ 1,73 m2.
    21. Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Participants alive and independent of supplementary oxygen.
    Pacientes vivos e independientes del aporte de oxígeno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    E.5.2Secondary end point(s)
    • All-cause mortality
    • Time to last dependence on supplementary oxygen
    • Participants alive and independent of supplementary oxygen
    • ICU admission
    • Time to final ICU discharge
    • Time to final hospital discharge
    • Occurrence of adverse events (AEs)
    • Occurrence of serious adverse events (SAEs)
    - Mortalidad por cualquier causa.
    - Tiempo hasta la última dependencia del aporte de oxígeno.
    - Sujetos participantes vivos e independientes del aporte de oxígeno.
    - Admisión en UCI
    - Tiempo hasta el alta de la UCI
    - Tiempo hasta el alta de la hospitalización
    - Ocurrencia de acontecimientos adversos (AA)
    - Ocurrencia de acontecimientos adversos graves (AAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints up to Day 60.
    Varios momentos de evaluación hasta 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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned9
    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 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
    France
    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
    The end of the study is defined as the date of the last contact of the last participant in the study.
    Se define el final del estudio como la fecha del último contacto con el último paciente en el estudio.
    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 months6
    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 months6
    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: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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
    If participants are not capable of giving informed consent, consent maybe obtained from a legal representative.
    Si los pacientes no son capaces de dar su consentimiento informado, se puede obtener el consentimiento de su representante legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 800
    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
    ninguna
    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 Decision2020-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-16
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