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    Summary
    EudraCT Number:2021-002968-49
    Sponsor's Protocol Code Number:BN43118
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-06-24
    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 number2021-002968-49
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PATIENTS WITH GUILLAIN-BARRÉ SYNDROME
    ESTUDIO FASE III, ALEATORIZADO, DOBLE CIEGO, MULTICÉNTRICO, CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA, SEGURIDAD, FARMACOCINÉTICA Y
    FARMACODINAMIA DE CROVALIMAB EN PACIENTES CON SÍNDROME DE GUILLAIN-BARRÉ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients with Guillain-Barré Syndrome
    Un estudio para evaluar la eficacia, seguridad y farmacodinamia de crovalimab en pacientes con síndrome de Guillain-Barré
    A.3.2Name or abbreviated title of the trial where available
    SAROS
    SAROS
    A.4.1Sponsor's protocol code numberBN43118
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffman-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportChugai Pharmaceutical Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4047
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34603729575
    B.5.6E-mailspain.start_up_unit@roche.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 nameCrovalimab
    D.3.2Product code RO7112689
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCROVALIMAB
    D.3.9.2Current sponsor codeRO7112689
    D.3.9.4EV Substance CodeSUB197998
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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 placeboConcentrate for solution for injection/infusion
    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
    Guillain-Barré syndrome (GBS)
    síndrome de Guillain-Barré (SGB)
    E.1.1.1Medical condition in easily understood language
    Guillain-Barré Syndrome is an inflammatory disorder of the peripheral nerves outside the brain and spinal cord
    El síndrome de Guillain-Barré es un trastorno inflamatorio de los nervios periféricos fuera del cerebro y la médula espinal
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10018767
    E.1.2Term Guillain-Barre syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10018766
    E.1.2Term Guillain Barre syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042812
    E.1.2Term Syndrome Guillain-Barre
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of crovalimab compared with placebo as an add-on therapy to IVIg based on proportion of participants who reach Hughes functional grade (FG) <=1 on Guillain-Barré Syndrome Disability Scale (GBS-DS)
    • Evaluar la eficacia de crovalimab en comparación con placebo como tratamiento adicional a la IgIV en participantes con grado funcional (GF) de Hughes <=1 en la escala de discapacidad del síndrome de Guillain-Barré (GBS-DS)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of crovalimab compared with placebo as an add-on therapy to IVIg based on time to recover independent walking, functional outcome on GBS-DS, proportion of inflammatory Rasch-built Overall Disability Scale (I-RODS) responders, average post recovery time and duration of ventilator support
    • To evaluate the safety of crovalimab compared with placebo as an add-on therapy to IVIg
    • To evaluate the immune response to crovalimab as an add-on therapy to IVIg
    • To characterize crovalimab PK profile as an add-on therapy to IVIg
    • Evaluar la eficacia de crovalimab en comparación con placebo como tratamiento adicional a la IgIV basado en el tiempo en recuperar la marcha independiente, resultado funcional en GBS-DS, proporción de pacientes con respuesta I-RODS, tiempo medio posterior a la recuperación y duración de la ayuda respiratoria.
    • Evaluar la seguridad de crovalimab en comparación con placebo como tratamiento adicional a la IgIV.
    • Evaluar la respuesta inmunitaria a crovalimab como tratamiento adicional a la IgIV.
    • Caracterizar el perfil FC de crovalimab como tratamiento adicional a la IgIV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >= 18 at the time of signing Informed Consent Form
    • Body weight >= 40 kg at screening
    • Confirmed diagnosis of GBS according to National Institute of Neurological Disorders and Stroke (NINDS) classification system
    • Onset of weakness due to GBS within 2 weeks before randomization
    • Able to start the first dose of blinded study drug within 2 weeks of onset of weakness
    • Able to climb a flight of stairs prior to GBS
    • Unable to walk independently for >=10 meters (FG >=3) with deteriorating weakness as per investigator judgment, or FG 4 or FG 5 on the GBS-DS. These criteria must be satisfied during screening.
    • Undergoing or starting IVIg treatment (400 mg/kg QD for 5 days) prior to first blinded study drug administration. Participants must be able to receive the first dose of blinded study drug before the final dose of IVIg during the 5-day period of IVIg treatment.
    • A record of vaccination (<=3 years) against Neisseria meningitidis, Haemophilus influenzae type B, and Streptococcus pneumonia prior to initiation of blinded study drug, in accordance with most current local guidelines as applicable for patients with complement deficiency.
    • Adequate hepatic and renal function
    • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 6 months after the final dose of study treatment.
    •Edad>=18 años en el momento de la firma del formulario de consentimiento informado.
    •Peso corporal>=40 kg en la selección.
    •Diagnóstico confirmado de SGB según el sistema de clasificación NINDS.
    •Aparición de debilidad debido a SGB en las 2 semanas anteriores a la aleatorización.
    •Capaz de iniciar la primera dosis del fármaco del estudio ciego en las 2 semanas siguientes al inicio de la debilidad.
    •Capaz de subir un tramo de escaleras antes del SGB.
    •Incapaz de caminar de forma independiente >=10 metros (GF >=3) con debilidad deteriorante según el criterio del investigador, o GF 4 o GF 5 en la escala de discapacidad del SGB (GBS-DS). Estos criterios deben cumplirse durante la selección.
    •Estar recibiendo o iniciar tratamiento con IgIV (400 mg/kg 1 una vez al día durante 5 días) antes de la primera administración del fármaco del estudio ciego. Los participantes deben poder recibir la primera dosis del fármaco del estudio ciego antes de la última dosis de IgIV durante el periodo de 5 días del tratamiento con IgIV.
    •Un registro de vacunación (<=3 años) contra Neisseria meningitidis, Haemophilus influenzae tipo B y Streptococcus pneumonia antes del inicio del fármaco del estudio ciego, de acuerdo con las directrices locales más recientes, según corresponda para los pacientes con deficiencia del complemento.
    •Función hepática y renal adecuada.
    •Para las participantes en edad fértil: deben estar de acuerdo en mantener la abstinencia (evitar las relaciones heterosexuales) o el uso de anticonceptivos durante el periodo de tratamiento y durante 6 meses después de la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    • Clear clinical and historical evidence of significant or disabling acute or chronic peripheral neuropathy of alternative etiology, chronic inflammatory demyelinating polyneuropathy, severe vitamin deficiency, porphyria, or diagnosis of Charcot Marie Tooth disease or other genetic neuropathy
    • History of requiring a permanent aid to walk prior to GBS
    • Treatment with plasmapheresis or PLEX after GBS diagnosis, or a plan to receive this treatment
    • Receipt of systemic immunosuppressive treatment within 4 weeks prior to randomization
    • Known or suspected hereditary complement deficiency
    • Known or suspected immune deficiency
    • Recent use (up to five half-lives) of treatment with complement inhibitors (e.g., 10 weeks for eculizumab, 41 weeks for ravulizumab)
    • History of Neisseria meningitidis infection within 12 months prior to screening and up to first blinded study drug administration (Day 1)
    • Contraindication that would prevent use of any class of antibiotics as Neisseria meningitides prophylaxis
    • Immunization with a live attenuated vaccine within 1 month before first blinded study drug administration (Day 1)
    • Participants who have been partially or fully vaccinated against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation.
    • Recent SARS-CoV-2 infection (defined by a positive PCR test within the 2-week period prior to screening), or ongoing symptoms of active COVID-19
    • Any systemic bacterial, viral, or fungal infection ongoing at screening and up to the first blinded study drug administration (Day 1) which, in the investigators' judgment, is active and could potentially be worsened by immunosuppression
    • Current hepatitis B, hepatitis C, or HIV infection
    • History of malignancy within 5 years prior to screening and up to the first blinded study drug administration (Day 1)
    • History of hypersensitivity, allergic, or anaphylactic reactions to crovalimab or IVIg, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any constituent of the products
    • For participants with prior exposure to anti-CD20 agents, most recent anti-CD20 treatment within 6 months prior to screening
    • Substance abuse within 12 months prior to screening, in the investigator's judgment
    • Active suicidal ideation within 6 months prior to screening or history of suicide attempt within 3 years prior to screening
    • Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the patient, or would, in the opinion of the investigator, preclude the patient’s safe participation in and completion of the study
    • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half-lives of that investigational product, whichever is longer
    • Splenectomy <= 6 months prior to screening
    • Selective IgA deficiency with development of antibodies to IgA
    • Only applicable for participants receiving proline-containing IVIg products:
    • Only applicable for participants receiving sucrose/glucose/maltose-containing IVIg products
    • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 24 weeks after the final dose of crovalimab
    •Antecedentes o signos claros de neuropatía periférica aguda o crónica importante o discapacitante de etiología alternativa, polineuropatía desmielinizante inflamatoria crónica, deficiencia vitamínica grave, porfiria o diagnóstico de enfermedad de Charcot-Marie-Tooth u otra neuropatía genética.
    •Antecedentes de necesidad de ayuda permanente para caminar antes del SGB.
    •Tratamiento con plasmaféresis o PLEX después del diagnóstico de SGB, o un plan para recibir este tratamiento.
    •Recibir tratamiento inmunodepresor sistémico en las 4 semanas anteriores a la aleatorización.
    •Deficiencia hereditaria del complemento conocida o sospechada
    •Inmunodeficiencia conocida o sospechada
    •Uso reciente (hasta cinco semividas) de tratamiento con inhibidores del complemento (p.ej., 10 semanas para eculizumab, 41 semanas para ravulizumab)
    •Antecedentes de infección por Neisseria meningitidis en los 12 meses anteriores a la selección y hasta la primera administración del fármaco del estudio ciego (día 1)
    •Contraindicación que impediría el uso de cualquier clase de antibióticos como profilaxis para Neisseria meningitidis
    •Inmunización con una vacuna viva atenuada en el mes anterior a la primera administración del fármaco del estudio ciego (día 1)
    •Los participantes que hayan sido vacunados parcial o totalmente contra SARS-CoV-2 con una vacuna aprobada localmente son aptos para ser incluidos en el estudio, 3 días o más después de la inoculación
    •Infección reciente por SARS-CoV-2 (definida mediante una prueba de PCR positiva en el periodo de las 2 semanas anteriores a la selección) o síntomas en curso de COVID-19 activa
    •Cualquier infección bacteriana, vírica o fúngica sistémica en curso en la selección y hasta la primera administración del fármaco del estudio ciego (día 1) que, a juicio de los investigadores, esté activa y pueda empeorarse mediante inmunodepresión
    •Infección actual por hepatitis B, hepatitis C o VIH
    •Antecedentes de neoplasia maligna en los 5 años anteriores a la selección y hasta la primera administración del fármaco del estudio ciego (día 1)
    •Antecedentes de reacciones de hipersensibilidad, alérgicas o anafilácticas a crovalimab o IgIV, incluida la hipersensibilidad a anticuerpos monoclonales humanos, humanizados o murinos, o hipersensibilidad conocida a cualquier componente de los fármacos
    •Para los participantes con exposición previa a fármacos anti-CD20, el tratamiento anti-CD20 más reciente en los 6 meses anteriores a la selección
    •Abuso de drogas en los 12 meses anteriores a la selección, a juicio del investigador
    •Ideas suicidas activas en los 6 meses anteriores a la selección o antecedentes de intento de suicidio en los 3 años anteriores a la selección
    •Enfermedad concomitante, tratamiento, procedimiento o cirugía, o anomalía en las pruebas de laboratorio clínico que pudieran interferir con la realización del estudio, puedan suponer cualquier riesgo adicional para el paciente o, en opinión del investigador, impedir la participación segura del paciente en el estudio y la finalización del mismo
    •Participación en otro estudio de tratamiento intervencionista con un fármaco en investigación o uso de cualquier tratamiento experimental en los 28 días anteriores a la selección o en las cinco semividas de ese fármaco en investigación, lo que sea más largo
    •Esplenectomía <=6 meses antes de la selección
    •Deficiencia selectiva de IgA con desarrollo de anticuerpos contra IgA
    •Solo aplicable a los participantes que reciban fármacos de IgIV que contengan prolina
    •Solo aplicable para participantes que reciban fármacos de IgIV que contengan sacarosa/glucosa/maltosa
    •Embarazo o lactancia, o intención de quedarse embarazada durante el estudio o en las 24 semanas posteriores a la última dosis de crovalimab
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of participants who reach FG <=1 on GBS-DS at Week 24
    Proporción de participantes que alcanzan el GF <=1 en GBS-DS en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 24
    1. semana 24
    E.5.2Secondary end point(s)
    1. Time to recover independent walking, defined as time from randomization to the first time point at which the participant is able to walk independently, as assessed using 10-MWT
    2. Functional outcome on GBS-DS at Week 8
    3. Proportion of I-RODS responders at Week 24, defined as a participant who is able to perform all activities assessed by the I-RODS with or without some difficulties (graded 1 or 2)
    4. Average postrecovery time, defined as the time from reaching FG <= 1 for the first time after randomization to Week 24
    5. Duration of ventilator support during the 24 weeks following randomization
    6. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading
    7. Change from baseline in targeted vital signs and clinical laboratory test results
    8. Incidence and severity of injection site reactions, infusion-related reactions, and hypersensitivity
    9. Incidence and severity of infections (including meningococcal meningitis)
    10. Incidence of adverse events leading to study drug discontinuation
    11. Prevalence of ADAs at baseline and incidence of ADAs during the study
    12. Descriptive summary of crovalimab serum concentrations per time point
    1. Tiempo en recuperar la marcha independiente definido como el tiempo transcurrido desde la aleatorización hasta el primer punto temporal en el
    que el participante es capaz de caminar de forma independiente, evaluado mediante la 10‐MWT.
    2. Resultado funcional en GBS-DS en la semana 8
    3. Proporción de pacientes con respuesta I-RODS en la semana 24, definida como un participante capaz de realizar todas las actividades evaluadas por el IRODS con o sin algunas dificultades (grado 1 o 2)
    4. Tiempo medio posterior a la recuperación, definido como el tiempo transcurrido desde la consecución del GF <=1 por primera vez después de la aleatorización hasta la semana 24
    5. Duración de la ayuda respiratoria durante las 24 semanas posteriores a la aleatorización
    6. Incidencia e intensidad de los acontecimientos adversos, con intensidad determinada según la clasificación de CTCAE v5.0 del NCI
    7. Cambio con respecto al inicio en las constantes vitales objetivo y los resultados de las pruebas analíticas clínicas
    8. Incidencia e intensidad de las reacciones en el lugar de la inyección, reacciones relacionadas con la infusión e hipersensibilidad
    9. Incidencia e intensidad de las infecciones (incluida la meningitis meningocócica)
    10. Incidencia de acontecimientos adversos que provocaron la interrupción del fármaco del estudio
    11. Prevalencia de AAF al inicio e incidencia de AAF durante el estudio
    12. Resumen descriptivo de las concentraciones séricas de crovalimab por punto temporal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, Day 2, Week 1-4, Week 8, 12, 20, 24, 28, 36, 52
    2. Week 8
    3. Week 24
    4-5. Randomization to Week 24
    6-10. Up to 52 weeks
    11. Day 1, Day 2, Week 1-4, Week 8, 12, 20, 24, 28, 36, 52
    12. Day 1, Week 1-4, Week 8, 12, 20, 24, 28, 36, 52
    1. Día 1, día 2, semana 1-4, semana 8, 12, 20, 24, 28, 36, 52
    2. Semana 8
    3. Semana 24
    4-5. Aleatorización a la semana 24
    6-10. Hasta la semana 52
    11. Día 1, día 2, semana 1-4, semana 8, 12, 20, 24, 28, 36, 52
    12. Día 1, semana 1-4, semana 8, 12, 20, 24, 28, 36, 52
    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 No
    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) 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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Australia
    Canada
    India
    Japan
    Korea, Republic of
    Mexico
    Peru
    United States
    Netherlands
    Spain
    Italy
    Turkey
    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
    LPLV or the date at which the last data point required for statistical analysis or safety follow-up is received from the last participant, whichever occurs later.
    UVUP o la fecha en la que se recibe del último participante el último punto de datos requerido para el análisis estadístico o el seguimiento de seguridad, lo que ocurra más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 154
    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)
    Currently, the Sponsor does not have any plans to provide Roche IMP crovalimab or any other study treatments to participants who have completed the study. The Sponsor may evaluate whether to continue providing crovalimab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Actualmente, el promotor no tiene planes para proporcionar el IMP de Roche, crovalimab, ni ningún otro tratamiento del estudio a los participantes que hayan completado el estudio. El Patrocinador puede evaluar si continúa proporcionando crovalimab de acuerdo con la Política Global de Roche sobre el Acceso Continuo al Medicamento en Investigación, disponible en el siguiente sitio web:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pd
    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 Decision2022-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-11-04
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