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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2020-002037-15
    Sponsor's Protocol Code Number:SARTRE
    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:2020-05-26
    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 number2020-002037-15
    A.3Full title of the trial
    Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
    Ensayo clínico multicéntrico, aleatorizado, y abierto para evaluar la eficacia y seguridad de SOC + sarilumab versus SOC para el tratamiento temprano de la neumonía por COVID-19 en pacientes hospitalizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
    Ensayo clínico multicéntrico, aleatorizado, y abierto para evaluar la eficacia y seguridad de SOC + sarilumab versus SOC para el tratamiento temprano de la neumonía por COVID-19 en pacientes hospitalizados
    A.4.1Sponsor's protocol code numberSARTRE
    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 SponsorCristina Avendaño Sola
    B.1.3.4CountrySpain
    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 supportSanofi Aventis S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Puerta de Hierro Majadahonda
    B.5.2Functional name of contact pointBelen Ruiz Antorán
    B.5.3 Address:
    B.5.3.1Street Addressc/ Manuel de Falla 1
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number0034911917479
    B.5.6E-mailmariabelen.ruiz@salud.madrid.org
    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 Kevzara 200 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    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.3.4Pharmaceutical form Solution for injection 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.3.9.3Other descriptive nameSARILUMAB
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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
    SARS-CoV-2 infected patients with pneumonia
    Neumonía por SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    COVID-Pneumonia
    Neumonía COVID
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of an early intervention with sarilumab in the prevention of progression to severe respiratory failure/ICU admission or death in SARS-CoV-2 infected patients with pneumonia and regular oxygen supplement requirements -(Brescia-COVID Score= 1).
    Evaluar la eficacia de una intervención temprana con sarilumab en la prevención de la progresión a insuficiencia respiratoria grave, ingreso en UCI o muerte en pacientes infectados por SARS-CoV-2 con neumonía y requerimientos de suplementos de oxígeno regulares (Brescia-COVID Score = 1).
    E.2.2Secondary objectives of the trial
    1. To assess differences between both strategies in the following:
    • Time to respiratory failure
    • Time to reduction of supplemental oxygen requirements
    • Time to non-invasive or invasive ventilation.
    • The duration of hospitalization
    • Mortality rate and survival.
    • Rate of ICU admission

    2. To evaluate the efficacy of sarilumab in in COVID-19 infected patients with pneumonia Brescia-COVID- >2 (open-label follow up phase).
    3. To evaluate safety of sarilumab treatment in treating patients with COVID-19 pneumonia.
    4. To evaluate differences in the effect of sarilumab on the serum levels of inflammatory cytokines.
    5. To evaluate differences in the proportion of patients showing more than >1 organ failure, e.g. cardiovascular, liver and kidney failure
    6. To identify prognosis factors of sarilumab efficacy related to laboratory parameters or disease features.
    1. Diferencias entre ambas estrategias en lo siguiente:
    • Tiempo hasta progresión de insuficiencia respiratoria.
    • Tiempo hasta la reducción de los requerimientos de oxígeno suplementario.
    • Tiempo hasta ventilación mecánica no invasiva o invasiva.
    • Duración de la hospitalización.
    • Tasa de mortalidad y supervivencia.
    • Tasa de ingreso en UCI
    2. Eficacia de sarilumab en pacientes infectados con COVID-19 con neumonía y Brescia-COVID-> 2 (fase de seguimiento abierta).
    3. Seguridad del tratamiento con sarilumab en el tratamiento de pacientes con neumonía por COVID-19.
    4. Evaluar las diferencias en el efecto de sarilumab sobre los niveles séricos de citocinas inflamatorias.
    5. Evaluar las diferencias en la proporción de pacientes que muestran falla > de 1 órgano, p. ejem. insuficiencia cardiovascular, hepática y renal
    6. Identificar los factores pronósticos de la eficacia del sarilumab relacionados con los parámetros de laboratorio o las características de la enfermedad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    1. Patients willing to provide written informed consent to participate in this study. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
    2. The patient is at least 18 years of age.
    3. The patient is positive for novel coronavirus by real-time RT-PCR
    4. The patient is hospitalized for COVID-19 without either mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag and at least one of the following:
    -Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam)
    - AND SpO2 ≤ 94% on room air that requires supplemental oxygen.

    5. More than 7 days between the onset of symptoms (fever, dysnea, and/or cough) and treatment administration day. In the absence of fever, cough, or dyspnea, other symptoms like asthenia, headache, or gastrointestinal symptoms may be considered
    6. The patients presents progressive elevation of inflammatory parameters suggestive of a hyperinflammatory syndrome:
    Presence of elevated IL-6 (>40pg/ml)
    or
    Elevated d-dimer (>1.0 mcg/ml), or alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
    Criterios de inclusión
    1. Pacientes que otorgan su consentimiento informado por escrito para participar en el estudio. Se aceptará el consentimiento oral ante testigo para evitar el manejo de papel. Se obtendrá el consentimiento por escrito del paciente o los representantes lo antes posible.
    2. Paciente adulto de ≥ 18 años de edad.
    3. Paciente positivo para el nuevo coronavirus por TR-PCR en tiempo real
    4. El paciente es hospitalizado por COVID-19 sin ventilación mecánica (invasiva o no invasiva) o mascarilla de oxígeno con reservorio y al menos uno de los siguientes:
    -Evidencia radiográfica de infiltrados pulmonares por imagen (radiografía de tórax, tomografía computarizada, etc.), o evaluación clínica (evidencia de estertores / crepitaciones en el examen)
    - Y SpO2 ≤ 94% en aire ambiente que requiere oxígeno suplementario.

    5. Más de 7 días entre el inicio de los síntomas (fiebre, disnea y / o tos) y el día de administración del tratamiento. En ausencia de fiebre, tos o disnea, se pueden considerar otros síntomas como astenia, dolor de cabeza o síntomas gastrointestinales.
    6. Los pacientes presentan elevación progresiva de los parámetros inflamatorios sugestivos de un síndrome hiperinflamatorio:
    -Presencia de IL-6 elevada (> 40pg / ml)
    o
    -Dímero D elevado (> 1.0 mcg / ml), o alternativamente, empeoramiento progresivo en al menos dos de estos parámetros inflamatorios en las 48 h previas: PCR, LDH, ferritina sérica, linfopenia o dímero d.
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. Requiring mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag at screening.
    2. Participation in any other clinical trial of an experimental treatment for COVID-19.
    3. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
    4. Any incompatibility or allergy to the administration of sarilumab or corticosteroids.
    Criterio de exclusión
    1. Requerir ventilación mecánica (invasiva o no invasiva) o mascarilla de oxígeno con reservorio.
    2. Participación en cualquier otro ensayo clínico con un tratamiento experimental para COVID-19.
    3. En opinión del equipo clínico, la progresión a la muerte es inminente e inevitable dentro de las próximas 24 horas, independientemente de la provisión de tratamientos.
    4. Cualquier incompatibilidad o alergia a la administración de sarilumab o corticosteroides
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients progressing to severe respiratory failure (Brescia-COVID Scale ≥2), ICU admission, or death.
    La variable primaria es la proporción de pacientes que progresan a insuficiencia respiratoria grave (escala Brescia-COVID ≥2), ingreso en la UCI o muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline up to Day-15
    Desde randomización a día 15
    E.5.2Secondary end point(s)
    Time to progression to severe respiratory failure (Brescia-COVID ≥2)
    Time to reduction of supplemental oxygen requirements
    Time to non-invasive or invasive mechanical ventilation.
    Rate of hospital discharge and duration of hospitalization
    Mortality rate and survival time
    Rate of ICU admissionProportion of patients with at least 1 point progression in the 7-point ordinal scale
    Ordinal scale:
    1) Not hospitalized, no limitations on activities.
    2) Not hospitalized, limitation on activities.
    3) Hospitalized, not requiring supplemental oxygen.
    4) Hospitalized, requiring supplemental oxygen.
    5) Hospitalized, on non-invasive ventilation or high flow oxygen devices or oxygen mask with reservoir bag.
    6) Hospitalized, on invasive mechanical ventilation or ECMO.
    7) Death.

    Changes from baseline to day 15th in serum levels of inflammatory cytokines.
    Proportion of patients showing more than >1 organ failure, e.g. cardiovascular, liver and kidney failure
    Safety and tolerability – Adverse events
    Tiempo hasta la progresión a insuficiencia respiratoria grave (Brescia-COVID ≥2)
    Tiempo hasta la reducción de los requerimientos de oxígeno suplementario.
    Tiempo hasta requerir ventilación mecánica no invasiva o invasiva.
    Tasa de alta hospitalaria y duración de la hospitalización.
    Tasa de mortalidad y de supervivencia.
    Tasa de ingreso en la UCI
    Proporción de pacientes con al menos 1 punto de progresión en la escala ordinal de 7 puntos:
    Escala ordinal:
    1) No hospitalizado, sin limitaciones en las actividades.
    2) No hospitalizado, limitación de actividades.
    3) Hospitalizado, que no requiere oxígeno suplementario.
    4) Hospitalizado, que requiere oxígeno suplementario.
    5) Hospitalizado, con ventilación no invasiva o dispositivos de oxígeno de alto flujo o máscara de oxígeno con bolsa de depósito.
    6) Hospitalizado, con ventilación mecánica invasiva o ECMO.
    7) Muerte.

    Cambios desde el inicio hasta el día 15 en los niveles séricos de citocinas inflamatorias.
    Proporción de pacientes con fallo en >1 órgano, por ejem. insuficiencia cardiovascular, hepática y renal
    Seguridad y tolerabilidad: eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline up to day-15
    Desde basal a día 15 post-aleatorización
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned8
    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 No
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state200
    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)
    Patients in any treatment group progressing to severe respiratory failure fulfilling criteria for treatment with anti-IL6 inhibitors according to clinical practice guidelines, as defined by the presence of Brescia-COVID 2-3 plus inflammatory markers, will be given the option to be rescued with sarilumab or any other treatment options based on physician´s judgement. IF sarilumb is given, the patient will be included in a 15-day open-label follow up phase.
    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 Decision2020-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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