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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2020-001644-25
    Sponsor's Protocol Code Number:ACE-ID-201/D822FC00001
    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:2020-05-14
    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 number2020-001644-25
    A.3Full title of the trial
    A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
    Ensayo fase II abierto, aleatorizado, de eficacia y seguridad de acalabrutinib y el mejor cuidado de apoyo frente al mejor cuidado de apoyo en sujetos hospitalizados con infección por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
    Ensayo fase II abierto, aleatorizado, de eficacia y seguridad de acalabrutinib y el mejor cuidado de apoyo frente al mejor cuidado de apoyo en sujetos hospitalizados con infección por COVID-19
    A.3.2Name or abbreviated title of the trial where available
    CALAVI
    A.4.1Sponsor's protocol code numberACE-ID-201/D822FC00001
    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 SponsorAcerta Pharma B.V.
    B.1.3.4CountryNetherlands
    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 supportAcerta Pharma B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta Pharma B.V.
    B.5.2Functional name of contact pointClinical Trial Call Center
    B.5.3 Address:
    B.5.3.1Street Address121 Oyster Point Blvd
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888 2929613
    B.5.6E-mailacertamc@dlss.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/196/15
    D.3 Description of the IMP
    D.3.1Product nameacalabrutinib
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACALABRUTINIB
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    D.3.9.4EV Substance CodeSUB182073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Subjects with life-threatening COVID-19 symptoms
    Pacientes con síntomas de COVID-19 potencialmente mortales
    E.1.1.1Medical condition in easily understood language
    Subjects with life-threatening COVID-19 symptoms
    Pacientes con síntomas de COVID-19 potencialmente mortales
    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 PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus 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
    The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19
    El objetivo general del estudio es evaluar la eficacia de la adición de acalabrutinib al MTS para el tratamiento de COVID-19
    E.2.2Secondary objectives of the trial
    To evaluate the safety of acalabrutinib in subjects with COVID-19 when administered with BSC

    To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC
    Evaluar la seguridad de acalabrutinib en pacientes con COVID-19 cuando se administra con MTS

    Evaluar la farmacocinética de acalabrutinib y su metabolito activo en pacientes con COVID-19 cuando se administra con MTS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Part 1 (Randomized cohort):
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
    2. Men and women ≥18 years of age at the time of signing the informed consent form
    3. Confirmed infection with SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
    4. Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
    5. Willing to follow contraception guidelines

    For Part 2 Intensive Care Unit (ICU Cohort):
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
    2. Men and women ≥18 years of age at the time of signing the informed consent form
    3. Confirmed infection with SARS-CoV-2 per WHO criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
    4. Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
    5. Willing to follow contraception guidelines
    Para la Parte 1 (Cohorte aleatorizada):
    1. Capacidad para entender el propósito y los riesgos del estudio y proporcionar su consentimiento informado firmado y fechado o hacer que un representante legal proporcione consentimiento y autorización para utilizar información médica protegida (de acuerdo con la legislación nacional y local de privacidad del paciente)
    2. Hombres y mujeres mayores de18 años de edad, en el momento de firmar el formulario de consentimiento informado
    3. Infección por COVID-19 confirmada por los criterios de la Organización Mundial de la Salud (OMS) (incluyendo una prueba positiva de ácido nucleico de cualquier tipo [por ejemplo, respiratoria, sangre, orina, heces u otro líquido corporal] en de los 4 días previos a la aleatorización.
    4. Capaz de tragar cápsulas o recibir la administración del contenido de las cápsulas a través de una vía nasogástrica (NG) o un tubo de alimentación enteral
    5. Dispuesto a seguir las instrucciones anticonceptivas

    Para la Parte 2 (Cohorte de la UCI):
    1. Capacidad para entender el propósito y los riesgos del estudio y proporcionar su consentimiento informado firmado y fechado o hacer que un representante legal proporcione consentimiento y autorización para utilizar información médica protegida (de acuerdo con la legislación nacional y local de privacidad del paciente)
    2. Hombres y mujeres mayores de 18 años de edad en el momento de firmar el formulario de consentimiento informado
    3. Infección por COVID-19 confirmada por los criterios de la Organización Mundial de la Salud (OMS) (incluyendo una prueba positiva de ácido nucleico de cualquier tipo [por ejemplo, respiratoria, sangre, orina, heces u otro líquido corporal] en de los 4 días previos a la aleatorización.
    4. Capaz de tragar cápsulas o recibir la administración del contenido de las cápsulas a través de una vía nasogástrica (NG) o un tubo de alimentación enteral
    5. Dispuesto a seguir las instrucciones anticonceptivas
    E.4Principal exclusion criteria
    For Part 1 and Part 2 (All Subjects):
    1. Pregnant or breast feeding
    2. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
    3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
    4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
    For Part 1:
    1. Respiratory failure before randomization
    2. Known medical resuscitation within 14 days of randomization

    For Part 2:
    1. Randomization to Part 1
    Criterios de exclusión para la Parte 1 y la Parte 2 (Todos los pacientes):
    1. Embarazada o amamantando
    2. Sospecha de infección bacteriana activa no controlada, fúngica, viral u otra infección (además de COVID-19)
    3. Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 5 x límite superior de normalidad (ULN) detectado dentro de las 24 horas en el cribado (por laboratorio local)
    4. Arritmias sintomáticas no controladas o no tratadas, infarto de miocardio en las últimas 6 semanas, insuficiencia cardíaca congestiva (Grado 3 ó 4 de la New York Heart Association [NYHA]). Excepción: Los sujetos con fibrilación auricular controlada y asintomática durante el screening, pueden incluirse en el estudio.
    Criterios de exclusión para la Parte 1:
    1. Insuficiencia respiratoria antes de la aleatorización.
    2. Reanimación médica conocida dentro de los 14 días desde la aleatorización
    Criterios de exclusión para la Parte 2:
    1. Aleatorización en Parte 1
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Primary Endpoint is Proportion of subjects alive and free of respiratory failure at Day 14.

    Part 2: Proportion of subjects alive and free of respiratory failure at Day 28

    For the purpose of this study, respiratory failure, is defined based on resource utilization of any of the following modalities:
    (a) Endotracheal intubation and mechanical ventilation
    (b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5)
    (c) Noninvasive positive pressure ventilation or continuous positive airway pressure
    (d) Extracorporeal membrane oxygenation
    Parte 1: El objetivo principal es la proporción de sujetos vivos y sin insuficiencia respiratoria en Dia 14
    Parte 2: Proporción de sujetos vivos y sin insuficiencia respiratoria en Dia 28
    (a) Intubación endotraqueal y ventilación mecánica
    (b) Oxígeno administrado por una cánula nasal de alto flujo (calentado, humidificado, oxígeno administrado a través de una cánula nasal reforzada a velocidades de flujo > 20L/min con una fracción de oxígeno administrado >0.5)
    (c) Ventilación con presión positiva no invasiva o presión positiva continua en la vía aérea
    (d) Oxigenación por membrana extracorpórea
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: 14 days
    Part 2: 28 days
    Parte 1: 14 días
    Parte 2: 28 días
    E.5.2Secondary end point(s)
    Part 1:
    Proportion of subjects alive and free of respiratory failure (as defined above) at Day 28
    Percent change from baseline in C-reactive protein (time frame: baseline, Days 3, 5, 7, 10)
    Change from baseline in ferritin (time frame: baseline, Days 3, 5, 7, 10)
    Change from baseline in absolute lymphocyte counts (time frame: baseline, Days 3, 5, 7, 10)
    Part 2:
    Proportion of subjects alive and free of respiratory failure (as defined above) at Day 14
    Percent change from baseline in C-reactive protein (time frame: baseline, Days 3, 5, 7, 10, 14)
    Change from baseline in ferritin (time frame: baseline, Days 3, 5, 7, 10, 14)
    Change from baseline in absolute lymphocyte counts (time frame: baseline, Days 3, 5, 7, 10, 14)
    Change from baseline in modified SOFA (time frame: baseline, Days 3, 5, 7, 10, 14)
    Part 1 and Part 2:
    All-cause mortality at Day 90
    Proportion of subjects alive and discharged from the ICU at Days 14, 28
    Time from randomization to first occurrence of respiratory failure or death on study (up to 28 days after randomization) due to any cause
    Number of days alive and free of respiratory failure from randomization to 28 days after randomization
    Number of days with respiratory failure from randomization to 28 days after randomization
    Number of days hospitalized from randomization to 28 days after randomization
    Number of days in ICU (length of stay) from randomization to 90 days after randomization
    Number of days alive outside of hospital from randomization to 28 days after randomization
    Number of days alive outside of hospital from randomization to 90 days after randomization
    Relative change from baseline in oxygenation index (PaO2/FiO2) to Day 5
    Type, frequency, severity, and relationship to study treatment of any treatment emergent adverse events (TEAEs) or abnormalities of laboratory tests, serious adverse events (SAEs), or adverse events (AEs) leading to discontinuation of study treatment.
    Acalabrutinib maximum observed concentration (Cmax), time to Cmax (tmax), half-life (t1/2), AUC0-time, and its active metabolite, ACP-5862 Cmax, and other PK parameters (eg CL/F or Vdss/F) where appropriate
    Parte 1:
    • Proporción de sujetos vivos y sin insuficiencia respiratoria (definida anteriormente) en Dia 28
    • Cambio porcentual con respecto al valor inicial en la proteína C reactiva (periodo de tiempo: basal, días 3, 5, 7, 10)
    • Cambio desde la visita basal en ferritina (periodo de tiempo: basal, días 3, 5, 7, 10)
    • Cambio desde visita basal en recuento absoluto de linfocitos (periodo de tiempo: basal, días 3, 5, 7, 10)
    Parte 2:
    • Proporción de sujetos vivos y sin insuficiencia respiratoria (definida anteriormente) en Dia 14
    • Cambio porcentual con respecto al valor inicial en la proteína C reactiva (periodo de tiempo: basal, días 3, 5, 7, 10, 14)
    • Cambio desde la visita basal en ferritina (periodo de tiempo: basal, días 3, 5, 7, 10, 14)
    • Cambio desde visita basal en recuento absoluto de linfocitos (periodo de tiempo: basal, días 3, 5, 7, 10, 14)
    • Cambio desde visita basal en SOFA modificado (periodo de tiempo: 3, 5, 7, 10, 14)
    Parte 1 y Parte 2:
    • Mortalidad por cualquier causa en Día 90
    • Proporción de sujetos vivos y dados de alta de UCI en Día 14 y Día 28
    • Tiempo desde la aleatorización a la primera aparición de insuficiencia respiratoria o muerte en el estudio (hasta 28 días después de la aleatorización) por cualquier causa
    • Número de días de vida y sin insuficiencia respiratoria desde la aleatorización hasta 28 días después de la aleatorización
    • Número de días con insuficiencia respiratoria desde la aleatorización hasta 28 días después de la aleatorización
    • Número de días de hospitalización desde la aleatorización hasta 28 días después de la aleatorización
    • Número de días en la UCI (duración de la estancia) desde la aleatorización hasta 90 días después de la aleatorización
    • Número de días de vida fuera del hospital desde la aleatorización hasta 28 días después de la aleatorización
    • Número de días de vida fuera del hospital desde la aleatorización hasta 90 días después de la aleatorización
    • Cambio relativo en el índice de oxigenación (PaO2 / FiO2) desde la visita basal hasta Día 5
    • Tipo, frecuencia, intensidad y relación con el tratamiento del estudio de cualquier acontecimiento adverso surgido durante el tratamiento (AAST) o anomalía analítica, acontecimiento adverso grave (AAG) o acontecimiento adverso (AA) que motive la suspensión del tratamiento del estudio.
    • Concentración máxima de acalabrutinib (Cmax ) observada, tiempo hasta Cmax (tmax), vida media (t1/2), AUC0-time , y su metabolito activo ACP-5862 Cmax, y otros parámatrosfarmacocinéticos (ej. CL/F o Vdss/F) adecuados
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 28 days and for survival status approximately 90 days
    Aproximadamente 28 días y para el estado de supervivencia aproximadamente 90 días
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mejor tratamiento de sostén (MTS)
    Best supportive care
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Italy
    Spain
    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
    LVLS
    LVLS
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 260
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Teckro Limited
    G.4.3.4Network Country Ireland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-15
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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