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    The EU Clinical Trials Register currently displays   43602   clinical trials with a EudraCT protocol, of which   7206   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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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2020-001255-40
    Sponsor's Protocol Code Number:STRIKE-SARS-CoV2
    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:2020-04-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001255-40
    A.3Full title of the trial
    Sarilumab Treatment In cytoKinE storm caused by infection with COVID-19.
    Tratamiento con sarilumab para síndrome de liberación de citoquinas causado por infección con COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sarilumab Treatment In cytoKinE storm caused by infection with COVID-19.
    Tratamiento con sarilumab para síndrome de liberación de citoquinas causado por infección con COVID-19.
    A.4.1Sponsor's protocol code numberSTRIKE-SARS-CoV2
    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 SponsorClínica Universidad de Navarra/Universidad de Navarra
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClínica Universidad de Navarra
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClínica Universidad de Navarra
    B.5.2Functional name of contact pointUCEC
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.4Telephone number34948255 4002723
    B.5.5Fax number34948296 667
    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. name Kevzara
    D. of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    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 INNSARILUMAB
    D.3.9.1CAS number 1189541-98-7
    D.3.9.4EV Substance CodeSUB177914
    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. 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe pneumonia caused by infection with SARS CoV 2.
    Neumonía grave por infección con SARS-CoV-2.
    E.1.1.1Medical condition in easily understood language
    Severe pneumonia caused by infection with SARS CoV 2.
    Neumonía grave por infección con SARS-CoV-2.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus 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
    Evaluate the impact of sarilumab on the progression of COVID 19-associated respiratory failure as measured by the change in a severity rating on a 7-point severity index.
    El objetivo principal es evaluar el impacto de sarilumab en la progresión de la insuficiencia respiratoria severa en enfermos con COVID-19 medida como el cambio en la escala ordinal de gravedad de 7 puntos.
    E.2.2Secondary objectives of the trial
    1. Assess the impact of sarilumab on markers of systemic inflammation and the coagulation cascade in the context of COVID-19.
    2. Assess the impact of sarilumab on mortality caused by COVID-19.

    3. Assess the impact of sarilumab on oxygenation.
    4. Evaluate the safety of sarilumab in patients with severe pneumonia caused by COVID 19.
    Como objetivos secundarios se evaluará el efecto de sarilumab en marcadores inflamatorios y de la coagulación y en la oxigenación, así como en la mortalidad por COVID-19.
    Además, se valorará la seguridad de sarilumab en estos pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
    In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.

    2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.

    3. Negative pregnancy test in case of fertile women*

    4. Greater than or equal to 18 years old

    5. Infection by COVID-19 confirmed by rtPCR or other validated tests

    6. Hospitalized (or documentation of a plan to admit to the hospital if the patient is in the emergency department) with illness of any duration, with evidence of pneumonia, and severe disease as defined by at least one of the following:
    a. High oxygen requirements (face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula)
    b. Lymphocytes < 0.8 x 109/L
    c. Serum ferritin > 300ng/mL
    d. Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.
    e. CPR > 10 mg/dL, or increasing over 24 hours

    * A woman is considered 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.
    1. Consentimiento informado por escrito antes de realizar los procedimientos del estudio. Se aceptará el consentimiento oral para evitar el manejo del papel. Se obtendrá el consentimiento por escrito del paciente o los representantes lo antes posible.
    En el caso de una emergencia vital sin la posibilidad de consentimiento previo, un paciente puede ser incluido en el estudio si se siguen las recomendaciones de la legislación (RD 1090/2015, artículo 7), como se indica en la sección 10.3 del protocolo.
    2. El paciente debe ser, en opinión del investigador, capaz de cumplir con todos los procedimientos del protocolo.
    3. Prueba de embarazo negativa en caso de mujeres fértiles *
    4. Edad mayor o igual a 18 años.
    5. Infección por COVID-19 confirmada por rtPCR u otras pruebas validadas
    6. Hospitalizado (o documentación de un plan para ingresar al hospital si el paciente se encuentra en el departamento de emergencias) con una enfermedad de cualquier duración, con evidencia de neumonía y enfermedad grave según la definición de al menos uno de los siguientes:
    a. Altos requerimientos de oxígeno (mascarilla con depósito, ventilación mecánica no invasiva o cánula nasal de alto flujo)
    b. Linfocitos <0.8 x 109 / L
    c. Ferritina sérica> 300ng / mL
    d. Niveles aumentados de dímero D (> 1500 ng / ml) o dímero D aumentando progresivamente (en 3 mediciones consecutivas) y alcanzando ≥ 1000 ng / ml.
    e. RCP> 10 mg / dL, o aumento en 24 horas

    * Una mujer se considera fértil, después de la menarquia y hasta llegar a ser posmenopáusica, a menos que esté permanentemente estéril. Los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral. Un estado posmenopáusico se define como la ausencia de menstruaciones durante 12 meses sin una causa médica alternativa. Se puede utilizar un nivel alto de hormona estimulante del folículo (FSH) en el rango posmenopáusico para confirmar un estado posmenopáusico en mujeres que no usan anticoncepción hormonal o terapia de reemplazo hormonal. Sin embargo, en ausencia de 12 meses de amenorrea, una sola medición de FSH es insuficiente.
    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substance or any of the excipients listed in section 6 of the protocol

    2. Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days

    3. Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline

    4. Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.

    5. Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline

    6. Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.

    7. Intravenous immunoglobulin (IVIG) within the past 5 months or plans to receive during the study period

    8. Current use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day

    9. Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents

    10. Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin

    11. AST/ALT values > 5 x normal.

    12. Neutropenia (< 0.5 x 109/L).

    13. Sever thrombocytopenia (< 50 x 109/L).

    14. Sepsis caused by an alternative pathogen.

    15. Diverticulitis with risk of perforation.

    16. Ongoing infectious dermatitis.

    17. Patients with another active infection, including localized infections.

    18. Pregnant or breast-feeding females will be excluded

    19. Positive serology for following infection: HIV, Hepatitis B, or C.
    1. Hipersensibilidad al principio activo o a alguno de los excipientes incluidos en la sección 6.

    2. Tratamiento con anti-IL 6, antagonistas anti-IL-6R o con inhibidores de la Janus quinasa (JAKi) en los últimos 30 días

    3. Agentes alquilantes, incluida la ciclofosfamida (CYC) dentro de los 6 meses posteriores al inicio

    4. Ciclosporina (CsA), azatioprina (AZA) o micofenolato mofetilo (MMF) o leflunomida dentro de las 4 semanas de la línea de base.

    5. Agentes alquilantes, incluida la ciclofosfamida (CYC) dentro de los 6 meses posteriores al inicio.

    6. Inhibidores del factor de necrosis tumoral (TNF) en 2 a 8 semanas (etanercept en 2 semanas, infliximab, certolizumab, golimumab o adalimumab en 8 semanas), o después de que hayan transcurrido al menos 5 vidas medias, lo que sea más largo.

    7. Inmunoglobulina intravenosa (IGIV) en los últimos 5 meses o planea recibirla durante el período de estudio.

    8. Uso actual de corticosteroides orales crónicos para una afección no relacionada con COVID-19 en una dosis superior a 10 mg de prednisona o equivalente por día

    9. Tratamiento actual con fármacos antirreumáticos modificadores de la enfermedad sintéticos convencionales (FARME) / agentes inmunosupresores

    10. Pacientes que han recibido terapia de anticuerpos inmunosupresores en los últimos 5 meses, incluida la inmunoglobulina intravenosa.

    11. Valores AST / ALT> 5 x normal.

    12. Neutropenia (<0.5 x 109 / L).

    13. Trombocitopenia grave (<50 x 109 / L).

    14. Sepsis causada por un patógeno alternativo.

    15. Diverticulitis con riesgo de perforación.

    16. Dermatitis infecciosa en curso.

    17. Pacientes con otra infección activa, incluidas infecciones localizadas.

    18. Las mujeres embarazadas o en periodo de lactancia serán excluidas

    19. Serología positiva para la siguiente infección: VIH, hepatitis B o C.
    E.5 End points
    E.5.1Primary end point(s)
    - Change in a severity rating on a 7-point ordinal scale

    7-point Ordinal Scale:
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen – requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen – no longer requires ongoing medical care
    7. Not hospitalized
    - Cambio en la escala ordinal de severidad de 7 puntos en el día 15

    Escala ordinal de valoración de la gravedad:
    1- Muerte
    2- Hospitalizado, con ventilación mecánica u oxigenación por membrana extracorpórea (ECMO).
    3- Hospitalizado, con ventilación mecánica no invasiva, mascarilla con reservorio u oxígeno con gafas nasales de alto flujo.
    4- Hospitalizado con suplemento de oxígeno
    5- Hospitalizado, sin suplemento de oxígeno, pero con necesidad de cuidado médico continuado (en relación o no con COVID)
    6- Hospitalizado, sin suplemento de oxígeno y sin necesidad de cuidado médico continuado
    7- No hospitalizado
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: day 15
    Día 15
    E.5.2Secondary end point(s)
    - Percentage of patients reporting each severity rating on a 7-point severity ordinal scale (time frame: day 28)

    - Duration of mechanical ventilation measured by days of ventilation since treatment (time frame: up to day 28)

    - Number of ventilator free days in the first 28 days (time frame: baseline to day 28)

    - Number of patients requiring mechanical ventilation (time frame: up to day 28)

    - Number of patients admitted to the ICU (time frame: up to day 28)

    - Change from baseline in PaO2/FiO2 in patients on mechanical ventilation (time frame: since day of intubation until day of extubation or up to day 28)

    - Time to improvement in oxygenation for at least 48 hours (time frame: up to day 28)

    o Increase in SpO2/FiO2 of 50 or more compared to nadir SpO2/FiO2

    - Time to saturation > 93.9% on room air (time frame: up to day 30)

    - Number of days with supplemental oxygen (time frame: up to day 30)

    - Time to resolution of fever without antipyretics for at least 48 hours (Tº > 36.6ºC – axilla; > 37.2ºC –oral; > 37.8 –rectal or tympanic) (time frame: up to day 30)

    - Changes from baseline in inflammatory parameters and other laboratory tests available on V2, V3, V4, V5, and V6: CRP, LDH, Ferritin, Troponin, BUN, creatinine, AST/ALT, bilirrubin (time frame: up to day 28)

    - Changes from baseline in white blood cell count if available on V2, V3, V4, V5, and V6 (time frame: up to 28 days or discharge)

    - Changes from baseline in hemoglobin levels if available on V2, V3, V4, V5, and V6 (time frame: up to 28 days or discharge)

    - Changes from baseline in platelet cell count if available on V2, V3, V4, V5, and V6 (time frame: up to 28 days or discharge)

    - Changes from baseline in D-Dimer leves if available on V2, V3, V4, V5, and V6 (time frame: up to 28 days or discharge)

    - Number of deaths due to any cause (time frame: up to day 28)

    - Organ failure (DIC, cardiac, hepatic, renal, cardiovascular) (time frame: up to day 28)
     Porcentaje de pacientes en los distintos grados de la escala ordinal de gravedad en el día 28.
     Duración de la ventilación mecánica (hasta día 28)
     Número de días sin ventilación mecánica (hasta día 28)
     Número de pacientes que requieren ventilación mecánica (hasta día 28)
     Número de pacientes que requieren UCI (hasta día 28)
     Cambio desde el basal en la PaO2/FiO2 durante la ventilación mecánica.
     Tiempo en alcanzar una mejoría en la oxigenación por lo menos durante 48 horas o aumento de SpO2 / FiO2 de 50 o más en comparación con el nadir SpO2 / FiO2
     Tiempo de saturación> 93.9% en aire ambiente (hasta el día 28)
     Número de días con oxígeno suplementario (hasta el día 28)
     Tiempo hasta la resolución de la fiebre sin antipiréticos durante al menos 48 horas (hasta el día 30)
     Cambio desde el inicio en los parámetros inflamatorios y otras pruebas de laboratorio (hasta el día 28)
     Cambio desde el inicio en el recuento de glóbulos blancos (hasta 28 días o alta)
     Cambio desde el inicio en los niveles de hemoglobina (hasta 28 días o alta)
     Cambio desde el inicio en el recuento de células plaquetarias (hasta 28 días o alta)
     Cambio desde la línea de base en los niveles de Dímero D (hasta 28 días o alta)
     Número de muertes por cualquier causa (hasta el día 28)
     Insuficiencia orgánica (hasta el día 28)
     Parámetros de seguridad: la aparición de eventos adversos y anomalías de laboratorio en los siguientes parámetros (hasta el día 28)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time frame: day 28.
    Día 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    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 months2
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    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)
    Will continue with the usual treatment for the pathology.
    Se continuará con el tratamiento habitual para la patología.
    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 Decision2020-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-10
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