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    Summary
    EudraCT Number:2020-001411-25
    Sponsor's Protocol Code Number:XPORT-COV-1001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-28
    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 number2020-001411-25
    A.3Full title of the trial
    A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients with Severe COVID-19 Infection
    Studio clinico di fase 2, randomizzato, in singolo cieco per valutare l’attività e sicurezza di selinexor (KPT-330) orale a basse dosi nei pazienti affetti da infezione da COVID-19 grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low Dose Oral Selinexor in Patients with Severe COVID-19 Infection
    Studio con selinexor in pazienti con infezione da COVID-19 grave
    A.4.1Sponsor's protocol code numberXPORT-COV-1001
    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 SponsorKaryopharm Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportKaryopharm Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKaryopharm Therapeutics Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address85 Wells Ave
    B.5.3.2Town/ cityNewton
    B.5.3.3Post codeMA 02459
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@karyopharm.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 nameSelinexor
    D.3.2Product code KPT-330, XPOVIO
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSelinexor
    D.3.9.1CAS number 1393477-72-9
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.3Other descriptive nameSELINEXOR
    D.3.9.4EV Substance CodeSUB177942
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe COVID-19 Infection
    Infezione da COVID-19 grave
    E.1.1.1Medical condition in easily understood language
    Severe infection caused by a novel coronavirus COVID-19
    Infezione grave causata dal nuovo coronavirus COVID-19
    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
    Day 14 Ordinal Time to Clinical Improvement (TTCI)
    Tempo fino al miglioramento clinico (TTCI)
    E.2.2Secondary objectives of the trial
    - Mortality
    - To determine the anti-inflammatory and immune effect of selinexor
    - To assess safety and tolerability of selinexor [time frame: up to 28 days]
    • Mortalità
    • Determinazone degli effetti antiinfiammatori e sul sitema immunitario di selinexor
    • Sicurezza e tollerabilità di Selinexor (fino a 28 giorni)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age =18 years
    2. Clinically suspected and subsequently confirmed; or laboratory diagnosis confirming
    patient is positive for SARS-CoV2 nucleic acid by RT-PCR (by local labs)
    3. Currently hospitalized and consented within the first 48 hours of hospitalization
    4. Informed consent provided as above
    5. Has symptoms of severe COVID-19 as demonstrated by:
    a. Respiratory rate =24 breaths/minute OR
    b. Pulse Oxygen Saturation (SpO2) =94% without oxygen inhalation, OR
    c. PaO2/FiO2 (fraction of inspired oxygen) =300 mm Hg
    6. Concurrent anti-virals and/or anti-inflammatory agents are permitted at baseline for
    patients entering the study
    7. Female patients of childbearing potential must have a negative serum pregnancy test
    at Screening. Female patients of childbearing potential and fertile male patients who
    are sexually active with a female of childbearing potential must use highly effective
    methods of contraception throughout the study and for 1 week following the last dose of
    study treatment. Highly effective methods of contraception are listed in Protocol
    Section 8.3.1.
    1. Età = 18 anni
    2. Sospetto clinico confermato successivamente oppure diagnosi di laboratorio che
    conferma che il paziente è positivo al virus SARS-CoV2 mediante rilevamento negli acidi
    nucleici della reazione a catena della polimerasi (PCR) con trascrittasi inversa (RT)
    (eseguito da laboratori a livello locale)
    3. Soggetto ospedalizzato che presti il suo consenso entro 48 ore dall’ospedalizzazione
    4. Consenso informato fornito secondo quanto riportato sopra
    5. Sintomi severi da Covid-19 ovvero:
    a. frequenza respiratoria = 24 respiri/minuto OPPURE
    b. saturazione (SpO2) = 94% senza uso di ossigeno supplementare OPPURE
    c. PaO2/FiO2 (frazione inspiratoria di ossigeno) =300 mm Hg
    6. La somministrazione concomitante di farmaci antivirali e/o antinfiammatori (ad es.,
    biofarmaci, idrossiclorochina) è permessa al basale per i pazienti che vengono inseriti
    nello studio
    7. Le pazienti in età fertile devono avere un test di gravidanza in siero negativo al
    momento dello screening. Le pazienti in età fertile e i pazienti fertili attivi
    sessualmente con donne in età fertile dovranno utilizzare metodi contraccettivi
    altamente efficaci durante tutta la durata dello studio e per una settimana dopo
    l’ultima dose del trattamento dello studio. I metodi contraccettivi altamente efficaci
    vengono riportati al punto 8.3.1 del protocollo.
    E.4Principal exclusion criteria
    1. Evidence of critical COVID-19 based on:
    a. Mechanical ventilation (invasive or non-invasive) or ECMO or hemofiltration required
    b. Shock
    2. In the opinion of the investigator, unlikely to survive for at least 48 hours from
    screening or anticipate mechanical ventilation within 48 hours
    3. Inadequate renal and liver function as indicated by the following labs:
    a. Creatinine clearance (CCL) <20 mL/min
    b. Aspartate transaminase (AST) or alanine transaminase (ALT) >5 x upper limit of normal
    (ULN)
    4. Unable to take oral medication
    1. Evidenza di COVID-19 critica sulla base di:
    a. Necessità di ventilazione meccanica (invasiva o non invasiva), ossigenazione
    extracorporea a membrana (ECMO) o emofiltrazione
    b. Shock
    2. Paziente che, secondo il parere dell’investigatore, abbia poche probabilità di
    sopravvivere per almeno 48 ore dopo lo screening o possa avere necessità di ventilazione
    meccanica entro 48 ore
    3. Funzionalità renale ed epatica inadeguata secondo quanto indicato dai seguenti esami
    di laboratorio:
    a. Clearance della creatinina <20 ml/min.
    b. Valore di aspartato transaminasi (AST) o di alanina transaminasi (ALT) superiore a 5
    volte il limite superiore di normalità (LSN)
    4. Non in grado di assumere farmaci per via orale
    E.5 End points
    E.5.1Primary end point(s)
    Absence of fever, oral temperature <38°C x 24 hours without antipyretics
    (acetaminophen) AND one of the following:
    - Respiratory rate =24/minute OR
    - Oxygen saturation >94% on room air OR
    - Hospital discharge
    Assenza di febbre: temperatura orale <38°C per 24 ore senza antipiretico
    (paracetamolo) NONCHÉ uno dei criteri indicati di seguito:
    - Frequenza respiratoria =24/minuto OPPURE
    - Saturazione di ossigeno =94% in aria ambiente OPPURE
    - Dimissione dall’ospedale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Durante il corso dello studio
    E.5.2Secondary end point(s)
    • All-cause mortality by D 28 after randomization
    • Rate of mechanical ventilation
    • Length of hospitalization
    • Length of ICU stay
    • Duration of oxygen supplementation
    • Duration of mechanical ventilation
    • Time to clinical failure, defined as the time to death, mechanical ventilation, or
    ICU admission
    • Vivi Disease Score
    • TTCI in patients =70 years old
    • TTCI in patients >70 years old
    • TTCI in patients that are immune compromised, have hypertension, or have pulmonary
    disease (smoking history or moderate to severe COPD)
    • Reduction of C-reactive protein (CRP)
    • Reduction in ferritin levels
    • LDH
    • Listing and documentation of frequency and severity of adverse effects
    • Mortalità per tutte le cause entro il 28º giorno dalla randomizzazione
    • Velocità e durata della ventilazione meccanica
    • Durata dell’utilizzo di ossigeno supplementare
    • Durata del ricovero ospedaliero
    • Durata della permanenza in terapia intensiva
    • Tempo fino al fallimento clinico, definito come il tempo fino al decesso, all’inizio
    della ventilazione meccanica o al trasferimento in terapia intensiva
    • Punteggio “Vienna Vaccine Safety Initiative (ViVI)” di gravità della malattia
    • TTCI in pazienti di età =70 anni
    • TTCI in pazienti di età >70 anni
    • TTCI in pazienti immunodepressi, ipertesi o affetti da malattia polmonare (fumatori
    o con broncopneumopatia cronica ostruttiva [BPCO] da moderata a grave)
    • Effetti sul livello di proteina C reattiva (PCR)
    • Effetti sul livello di ferritina
    • Effetti sulla lattato deidrogenasi (LDH)
    • Elencazione e documentazione della frequenza e gravità degli effetti avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mortality at day 28
    Rest of endpoints during the course of the study
    Mortalità = al giorno 28
    Gli altri endpoints = durante il corso dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Arruolamento stratificato per: area geografica e uso di terapie concomitanti
    enrollment stratified by: Use of concomitant therapies and High Risk Comorbidities
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Austria
    Belgium
    Canada
    France
    Germany
    India
    Israel
    Italy
    Malaysia
    Spain
    United Kingdom
    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
    A patient will be considered having completed the study if he/she has completed up to
    14 days of therapy (or 28 days per treating physician's discretion) or died.
    Completamento del trattamento fino a 14 giorni di terapia (o 28 giorni a discrezione
    dell’Investigatore) o morte
    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 months8
    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 months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 179
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient in emergency situation due to COVID-19 infection and consent is not able to be obtained.
    Pazienti in emergenza a causa dell’infezione da COVID-19 che non possono fornire
    il proprio consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 230
    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)
    After a patient has ceased his/her participation in the study, his/her medical doctor will offer the most appropriate treatment currently available.
    Una volta che il soggetto ha terminato lo studio, tornerà alla cura assegnatagli dal suo
    medico curante
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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