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    Summary
    EudraCT Number:2020-001162-12
    Sponsor's Protocol Code Number:EFC16844
    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:2020-04-03
    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 number2020-001162-12
    A.3Full title of the trial
    An adaptive phase 2/3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
    Estudio adaptativo de fase 2/3, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de sarilumab en pacientes hospitalizados por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sarilumab COVID-19
    Sarilumab COVID-19
    A.4.1Sponsor's protocol code numberEFC16844
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-6021
    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 SponsorSanofi-aventis Recherche et Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche et Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number3493485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 Kevzara®
    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.3.9.2Current sponsor codeSAR153191
    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) Yes
    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
    Corona virus infection
    Infección por coronavirus
    E.1.1.1Medical condition in easily understood language
    Corona virus infection
    Infección por 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus 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
    Phase 2: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19
    Phase 3: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19
    Fase 2: Evaluar la eficacia clínica de sarilumab en relación con el grupo control en pacientes adultos hospitalizados por COVID-19 grave
    Fase 3: Evaluar la eficacia clínica de sarilumab en relación con el grupo control en pacientes adultos hospitalizados por COVID-19 grave o crítico
    E.2.2Secondary objectives of the trial
    Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity, changes in the National Early Warning Score 2, duration of predefined symptoms and signs, duration of supplemental oxygen dependency, incidence of new mechanical ventilation use, the duration of new mechanical ventilation use, need for admission into ICU, duration of hospitalization, 28-day mortality rate.
    Secondary safety objectives are to evaluate the safety of sarilumab compared to the control arm as assessed by incidence of: SAEs, Grade 4 neutropenia (ANC<500/mm3) with concurrent severe or life-threatening bacterial, invasive fungal, or opportunistic infection, Grade ≥2 infusion related reactions, Grade ≥2 hypersensitivity reactions, Increase in ALT ≥3X ULN (for patients with normal baseline) or >3X ULN and at least 2-fold increase from baseline value (for patients with abnormal baseline), Invasive bacterial or fungal infections of clinical significance with confirmed diagnosis
    - Evaluar la eficacia clínica de sarilumab en comparación con grupo control según gravedad clínica, cambios en la NEWS (National Early Warning Score) 2, duración de síntomas y signos predefinidos, duración de dependencia suplementaria de oxígeno, incidencia del uso de nueva ventilación mecánica, duración del uso de nueva ventilación mecánica, necesidad de admisión en la UCI, duración de la hospitalización, tasa de mortalidad a los 28 días
    - Objetivos secundarios (seguridad): evaluar la seguridad de sarilumab con grupo control, según evaluación por la incidencia de AAG, neutropenia grado 4 (RAN < 500/mm3) con inf. bact., mic. invasiva u oportunista grave o pot. mortal concurrente, reac. rel. con la infusión de grado ≥ 2, reac. hipersensibilidad grado ≥ 2, aumento de ALT ≥3 veces LSN (pac. con valores basales normales) o > 3 veces LSN Y al menos 2 veces más del valor inicial (pac con valores basales anormales), infec bact. o fúngicas invasivas clín, signif. con diagnóstico confirmado
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must have severe disease, multi-system organ dysfunction or critical disease
    Laboratory-confirmed SARS-CoV-2 infection
    Los participantes deben tener una enfermedad grave, disfunción orgánica multisistémica o enfermedad crítica.
    Infección por SARS-CoV-2 confirmada por laboratorio
    E.4Principal exclusion criteria
    Unlikely to survive for >48 hours from screening
    Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than 5 X ULN, platelets less than 50,000/mmˆ3
    Prior immunosuppressive therapies
    Use of chronic oral corticosteroids for non-COVID-19 related condition
    Past or current history of autoimmune or inflammatory disease(s)
    Known or suspected history of tuberculosis
    Suspected or known active systemic bacterial or fungal infections
    Poco probable que sobreviva > 48 horas desde la selección
    recuento absoluto de neutrófilos (RAN) inferior a 2000/mm3, AST o ALT superior a 5 veces el LSN, plaquetas < 50 000 por mm3
    Cualquier uso anterior de tratamientos inmunodepresores
    Uso prolongado de corticosteroides orales para una enfermedad no relacionada con COVID-19
    Antecedentes de enfermedades autoinmunes o inflamatorias pasadas o actuales
    Historia sospechada o conocida de tuberculosis
    Pacientes con infecciones bacterianas o fúngicas sistémicas activas sospechadas o conocidas
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2: time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner
    Phase 3: The percentage of patients reporting each severity rating on the 7-point ordinal scale
    Fase 2: tiempo transcurrido hasta la resolución de la fiebre durante al menos 48 horas sin antipiréticos o hasta el alta, lo que suceda primero
    Fase 3: porcentaje de pacientes que notifican cada grado de severidad en la escala ordinal de 7 puntos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Day 29
    Desde el inicio hasta el día 29
    E.5.2Secondary end point(s)
    Phase 2
    1- The time to improvement in oxygenation
    2- Mean change in 7-point ordinal scale from baseline to Day 15
    3- Clinical status using the 7-point ordinal scale at Day 15
    4- Time to improvement of two categories from admission using the 7-point ordinal

    Phase 2 and 3
    5- Time to resolution of fever
    6- Time to improvement in oxygenation
    7- Time to resolution of fever and improvement in oxygenation
    8- Time to change in NEWS2 from baseline
    9- Time to NEWS2 of <2 and maintained for 24 hours
    10- Mean change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS2
    11- Days with fever
    12- Alive off supplemental oxygen at day 29
    13- Days of resting respiratory rate >24 breaths/min
    14- Days of hypoxemia
    15- Days of supplemental oxygen use
    16- Time to saturation ≥94% on room air
    17- Ventilator free days in the first 28 days (to day 29)
    18- The number of patients with Initiation of mechanical ventilation, non-invasive ventilation, or use of high flow nasal cannula
    19- The number of patients transferred to the ICU or the need to transfer to the ICU (if the ICU is not available)
    20- Days of hospitalization among survivors
    21- Incidence of death
    Phase 3
    22- Mean change in the 7-point ordinal scale from baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge)
    23- Clinical status using the 7-point ordinal scale at days 3, 5, 8, 11,15, and 29
    24- Time to improvement of two categories from admission using the 7-point ordinal scale
    Phase 2 and 3
    25- Incidence of serious adverse events
    26- The incidence of major or opportunistic bacterial or fungal infections
    27- The incidence of major or opportunistic bacterial or fungal infections in patients with grade 4 neutropenia
    28- The incidence of hypersensitivity reactions, infusion reactions, gastrointestinal perforation
    29- The number of patients with clinically significant laboratory abnormalities.
    Fase 2
    1- Tiempo hasta la mejora de la oxigenación
    2- Cambio medio en la escala ordinal de 7 puntos desde el inicio hasta el día 15
    3- Estado clínico utilizando la escala ordinal de 7 puntos el día 15
    4- Tiempo hasta la mejora de dos categorías desde el ingreso utilizando la escala ordinal de 7 puntos

    Fase 2 y 3:
    5- Tiempo hasta la resolución de la fiebre
    6- Tiempo hasta la mejora en la oxigenación
    7- Tiempo hasta la resolución de la fiebre y mejora de la oxigenación
    8- Tiempo hasta el cambio en la NEWS2 desde el inicio
    9- Tiempo hasta una NEWS2 < 2 y mantenida durante 24 horas
    10- Cambio medio desde el inicio hasta los días 3, 5, 8, 5,15 y 29 en NEWS2
    11- Días con fiebre
    12- Vivo sin oxígeno suplementario el día 29
    13- Días con una frecuencia respiratoria en reposo > 24 respiraciones/min
    14- Días con hipoxemia
    15- Días de uso de oxígeno suplementario
    16- Tiempo de saturación ≥ 94 % en aire ambiente
    17- Días sin ventilador en los primeros 28 días (hasta el día 29)
    18- Inicio de ventilación mecánica, ventilación no invasiva o uso de cánula nasal de alto flujo
    19- Número de pacientes transferidos a la UCI o la necesidad de transferirlos a la UCI [si la UCI no está disponible])
    20- Días de hospitalización entre los supervivientes
    21- Mortalidad por cualquier causa

    Fase 3:
    22- Cambio medio en la escala ordinal de 7 puntos desde el inicio hasta los días 3, 5, 8, 11, 15 y 29 (o hasta el alta)
    23- Estado clínico utilizando la escala ordinal de 7 puntos en los días 3, 5, 8,11,15 y 29
    24- Tiempo hasta la mejora de dos categorías desde el ingreso utilizando la escala ordinal de 7 puntos

    Fase 2 y 3:
    25- Incidencia de acontecimientos adversos graves
    26- Incidencia de infecciones bacterianas o fúngicas importantes u oportunistas
    27- Incidencia de infecciones bacterianas o fúngicas importantes u oportunistas en pacientes con neutropenia de grado 4
    28- Incidencia de reacciones de hipersensibilidad, reacciones a la infusión, perforación
    gastrointestinal
    29- Recuento de leucocitos, hemoglobina, plaquetas, creatinina, bilirrubina total, alanina aminotransferasa (ALT) los días 1, 3, 5, 8, 11, 15 y 29 (si aún está hospitalizado)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 4 to 9, 11 to 17, 24 : Baseline to Day 29
    2-3 : Baseline to Day 15
    10 : Baseline to Days 3, 5, 8, 11, 15 and 29
    18 to 21, 25 to 29 : Baseline to Day 60
    22 : Baseline to days 3, 5, 8, 11, 15, and 29 (or until discharge)
    23 : Days 3, 5, 8, 11,15, and 29
    1, 4 a 9, 11 a 17, 24 : Desde el inicio hasta el día 29
    2-3 : Desde el inicio hasta el día 15
    10 : Desde el inicio hasta los días 3, 5, 8, 11, 15 y 29
    18 to 21, 25 to 29 : Desde el inicio hasta día 60
    22 : Desde el inicio hasta to days 3, 5, 8, 11, 15 y 29 (o hasta el alta)
    23 : Días 3, 5, 8, 11,15, y 29
    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 Yes
    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) 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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Russian Federation
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última 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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 184
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 276
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally acceptable representative may provide informed consent.
    El representante legalmente aceptable puede dar su consentimiento informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 460
    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
    Ninguno
    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 Decision2020-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-02
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