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    Summary
    EudraCT Number:2020-001644-25
    Sponsor's Protocol Code Number:D822FC00001/ACE-ID-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-03
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio randomizzato, in aperto, di Fase II sull’efficacia e la sicurezza di Acalabrutinib in associazione alle migliori terapie di supporto rispetto alle sole migliori terapie di supporto in soggetti ricoverati con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
    Studio randomizzato, in aperto, di Fase II sull’efficacia e la sicurezza di Acalabrutinib in associazione alle migliori terapie di supporto rispetto alle sole migliori terapie di supporto in soggetti ricoverati con COVID-19
    A.3.2Name or abbreviated title of the trial where available
    CALAVI
    CALAVI
    A.4.1Sponsor's protocol code numberD822FC00001/ACE-ID-201
    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 BV
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportAcerta Pharma B.V.
    B.4.2CountryNetherlands
    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 number8882929613
    B.5.5Fax number000000
    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 nameacalabritinib
    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 INNacalabrutininb
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    D.3.9.3Other descriptive name-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Soggetti con sintomi COVID-19 potenzialmente letali
    E.1.1.1Medical condition in easily understood language
    Subjects with life-threatening COVID-19 symptoms
    Soggetti con sintomi COVID-19 potenzialmente letali
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19
    L'obiettivo generale dello studio è valutare l'efficacia dell'aggiunta di acalabrutinib a BSC per il trattamento di COVID-19
    E.2.2Secondary objectives of the trial
    To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC

    To evaluate the safety of acalabrutinib in
    subjects with COVID-19 when
    administered with BSC
    Per valutare la farmacocinetica di acalabrutinib e del suo metabolita attivo in soggetti con COVID-19 quando somministrato con BSC.
    Per valutare la sicurezza di acalabrutinib in soggetti con COVID-19 quando somministrato con BSC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 > or = 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. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
    5. Able to swallow pills
    6. Willing to follow contraception guidelines
    1. Capacità di comprendere lo scopo e i rischi dello studio e di fornire il consenso informato firmato e datato o di avere un rappresentante legale che fornisca il consenso e l'autorizzazione per l'uso di informazioni sanitarie protette (in conformità con le normative nazionali e locali sulla privacy dei pazienti)
    2. Uomini e donne > o = a 18 anni al momento della firma del modulo di consenso informato
    3. Infezione confermata con SARS-CoV-2 confermata secondo i criteri dell'Organizzazione mondiale della sanità (OMS) (compreso il test dell'acido nucleico positivo di qualsiasi campione [ad es. Respiratorio, sangue, urine, feci o altro fluido corporeo]) entro 4 giorni dalla randomizzazione
    4. Polmonite COVID-19 (documentata radiograficamente) che richiede ospedalizzazione e saturazione di ossigeno <94% sull' aria ambiente o richiede ossigeno supplementare
    5. In grado di deglutire le compresse
    6. Disponibilità a seguire le linee guida sulla contraccezione
    E.4Principal exclusion criteria
    1. Respiratory failure at time of screening due to COVID-19
    2. Known medical resuscitation within 14 days of randomization
    3. Pregnant or breast feeding
    4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
    5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin = 3x upper limit of normal (ULN) and/or severe hepatic impairment detected within 24 hours at screening (per local lab)
    6. 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
    7. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
    8. Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study
    9. Received oral antirejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study

    1. Insufficienza respiratoria al momento dello screening a causa di COVID-19
    2. Rianimazione medica nota entro 14 giorni dalla randomizzazione
    3. Gravidanza o allattamento
    4. Sospetta infezione batterica, fungina, virale o di altra natura attiva non controllata (oltre a infezione da SARS-CoV-2)
    5. Alanina aminotransferasi (ALT), aspartato aminotransferasi (AST) e / o bilirubina = 3x limite superiore della norma (ULN) e / o grave compromissione epatica rilevata entro 24 ore dallo screening (per laboratorio locale)
    6. Aritmie sintomatiche non controllate o non trattate, infarto del miocardio nelle ultime 6 settimane o insufficienza cardiaca congestizia (grado NYHA 3 o 4). Eccezione: i soggetti con fibrillazione atriale asintomatica controllata durante lo screening possono essere arruolati
    7. Trattamento con un potente inibitore del citocromo P450 (CYP) 3A (entro 14 giorni prima della prima dose del farmaco in studio) o induttore (entro 7 giorni prima della prima dose del farmaco in studio).
    8. Pazienti che richiedono un trattamento con inibitori della pompa protonica (IPP; ad es. Omeprazolo, esomeprazolo, lansoprazolo, dexlansoprazolo, rabeprazolo o pantoprazolo). I soggetti che ricevono PPI che passano agli antagonisti o agli antiacidi del recettore H2 sono eleggibili per lo studio
    9. Pazienti che hanno ricevuto farmaci antirigetto orale o immunomodulatori (p. Es., Anti-citochine, inibitori di Btk, inibitori di JAK, inibitori di PI3K) entro 30 giorni prima della randomizzazione sullo studio
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint is Proportion of subjects alive and free of respiratory failure at Day 14.

    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 > or = 0.5)
    (c) Noninvasive positive pressure ventilation or continuous positive airway pressure
    (d) Extracorporeal membrane oxygenation
    L' endpoint primario è la proporzione di soggetti vivi e liberi da insufficienza respiratoria al giorno 14.
    Ai fini di questo studio, l'insufficienza respiratoria è definita in base all'utilizzo delle risorse di una delle seguenti modalità:
    a) intubazione endotracheale e ventilazione meccanica
    b) Ossigeno erogato dalla cannula nasale ad alto flusso (riscaldato, umidificato, ossigeno erogato tramite cannula nasale rinforzata a portate> 20L / min con frazione di ossigeno erogato > o = 0,5)
    c) Ventilazione a pressione positiva non invasiva o pressione positiva continua delle vie aeree
    d) Ossigenazione extracorporea della membrana
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    14 giorni
    E.5.2Secondary end point(s)
    Proportion of subjects alive and free of respiratory failure (as defined above) at Day 28
    Percent change from baseline in CRP (time frame: baseline, Days 3, 5, 7, 10, 14, 28)
    Change from baseline in ferritin (time frame: baseline, Days 3, 5, 7, 10, 14, 28)
    Change from baseline in absolute lymphocyte counts (time frame: baseline, Days 3, 5, 7, 10, 14, 28)
    All-cause mortality at Day 90
    Proportion of subjects alive and discharged from the ICU at Days 14 and 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 TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment
    Acalabrutinib Cmax, tmax, t1/2, AUC0-time, and its active metabolite, ACP-5862 Cmax, and other PK parameters (eg CL/F or Vdss/F) where appropriate
    Proporzione di soggetti vivi e privi di insufficienza respiratoria (come definito sopra) al giorno 28
    Variazione percentuale rispetto al basale in CRP (intervallo di tempo: basale, giorni 3, 5, 7, 10, 14, 28)
    Variazione rispetto al basale in ferritina (intervallo di tempo: basale, giorni 3, 5, 7, 10, 14, 28)
    Variazione rispetto al basale della conta assoluta dei linfociti (intervallo di tempo: basale, giorni 3, 5, 7, 10, 14, 28)
    Mortalità per qualsiasi causa al giorno 90
    Proporzione di soggetti vivi e dimessi dall' ICU nei giorni 14 e 28
    Tempo dalla randomizzazione alla prima occorrenza di insufficienza respiratoria o morte durante lo studio (fino a 28 giorni dopo la randomizzazione) per qualsiasi causa
    Numero di giorni vivi e liberi da insufficienza respiratoria dalla randomizzazione a 28 giorni dopo la randomizzazione
    Numero di giorni con insufficienza respiratoria dalla randomizzazione a 28 giorni dopo la randomizzazione
    Numero di giorni ospedalizzati dalla randomizzazione a 28 giorni dopo la randomizzazione
    Numero di giorni in terapia intensiva (durata del soggiorno) dalla randomizzazione a 90 giorni dopo la randomizzazione
    Numero di giorni vivi fuori dall'ospedale dalla randomizzazione a 28 giorni dopo la randomizzazione
    Numero di giorni vivi al di fuori dell'ospedale dalla randomizzazione a 90 giorni dopo la randomizzazione
    Variazione relativa dal basale dell'indice di ossigenazione (PaO2 / FiO2) al Giorno 5
    Tipo, frequenza, gravità e relazione con lo studio del trattamento di TEAE o anomalie di test di laboratorio, SAE o eventi avversi che portano alla sospensione del trattamento in studio
    Cmax, tmax, t1 / 2, AUC0-time di Acalabrutinib, e il suo metabolita attivo, ACP-5862 Cmax e altri parametri PK (ad esempio CL / F o Vdss / F), se del caso
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 28 days and for survival status approximately 90 days
    circa 28 giorni e per lo stato di sopravvivenza circa 90 giorni
    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
    Best supportive care
    Best supportive care
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    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 days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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
    nessuno
    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 Decision2020-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    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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