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    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001411-25
    Sponsor's Protocol Code Number:XPORT-COV-1001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-04-17
    Trial 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 number2020-001411-25
    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
    Estudio fase 2, aleatorizado, ciego simple, para evaluar la actividad y seguridad de una dosis baja oral de Selinexor (KPT-330) en pacientes con infeccin grave COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    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.5.4Telephone number+34923 291 100
    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
    Infección grave por COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe infection caused by a novel coronavirus COVID-19
    Infección grave causada por el nuevo 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Time to Clinical Improvement (TTCI)
    Tiempo hasta mejora clnica (THMC)
    E.2.2Secondary objectives of the trial
    - Mortality
    - Additional Clinical Endpoints
    - To determine the anti-inflammatory and immune effect of selinexor
    - To assess safety and tolerability of selinexor [time frame: up to 28 days]
    - Mortalidad
    - Variables clnicas adicionales
    - Determinar los efectos antiinflamatorios e immunolgicos de selinexor
    - Evaluar la seguridad y la tolerabilidad de selinexor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > or =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 > or = 24 breaths/minute OR
    b. Pulse Oxygen Saturation (SpO 2 ) < or = 94% without oxygen supplementation, OR
    c. PaO 2 /FiO 2 (fraction of inspired oxygen) < OR = 300 mm Hg
    6. Concurrent anti-virals and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) 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.
    1. Edad> o = 18 aos
    2. Sospecha clnica y posterior confirmacin; o diagnstico de laboratorio que confirma que el paciente es positivo para el SARS-CoV2 por RT-PCR (por laboratorios locales)
    3. Actualmente hospitalizado y con consentimiento otrogado dentro de las primeras 48 horas de hospitalizacin
    4. Consentimiento informado provisto segn se indica arriba
    5. Tiene sntomas de COVID-19 grave segn
    a. Frecuencia respiratoria > o = 24 respiraciones / minuto O
    b. Saturacin de oxgeno (SpO 2) < o = 94% sin suplementacin de oxgeno, O
    C. PaO 2 / FiO 2 (fraccin de oxgeno inspirado) < o = 300 mm Hg
    6. Los antivirales y / o antiinflamatorios concurrentes (por ejemplo, productos biolgicos, hidroxicloroquina) estn permitidos al inicio del estudio para los pacientes que participan en el estudio
    7. Las pacientes en edad frtil deben tener una prueba de embarazo en suero negativa en la visita de seleccin. Las mujeres con potencial de procrear y pacientes masculinos frtiles que son sexualmente activos con una mujer en edad frtil debe utilizar mtodos anticonceptivos altamente efectivos durante todo el estudio y durante 1 semana despus de la ltima dosis de tratamiento del estudio.
    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. Evidencia de COVID-19 crtica basada en:
    a. Se requiere ventilacin mecnica (invasiva o no invasiva) o ECMO o hemofiltracin
    b. Shock
    2. En opinión del investigador, es poco probable que sobreviva al menos 48 horas despus de la deteccin o estime ventilacin mecnica dentro de las 48 horas.
    3. Inadecuada funcin renal y heptica segn lo indicado por los siguientes valores de laboratorio:
    a. aclaramiento de creatinina <20 ml / min
    si. Aspartato transaminasa (AST) o alanina transaminasa (ALT)> 5 x lmite superior de la normalidad (LSN)
    4. Incapaz de tomar medicacin oral
    E.5 End points
    E.5.1Primary end point(s)
    Absence of fever: oral temperature <38C x 24 hours without antipyretics (acetaminophen) AND one of the following:
    − Respiratory rate < or =24/minute OR
    − Oxygen saturation > or = 94% on room air OR
    − Hospital discharge
    Ausencia de fiebre: temperatura oral < 38 C durante 24 horas sin antipirticos (paracetamol) Y uno de los siguientes:
    - Frecuencia Respiratoria < o = 24/minuto O
    - Saturacin de oxgeno > o = 94% en aire ambiente O
    - Alta del hospital
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    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
    • Mortalidad por todas las causas a los 28 das despus de la aleatorizacin
    • Tasa y duracin de la ventilacin mecnica.
    • Duracin de la suplementacin con oxgeno.
    • Duracin de la hospitalizacin.
    • Duracin de la estancia en la UCI
    • Tiempo hasta el fracaso clnico, definido como el tiempo hasta la muerte, ventilacin mecnica o ingreso en la UCI
    • Puntuacin de la enfermedad de Vivi
    • THMCen pacientes < o =70 aos
    • THMC en pacientes > 70 aos
    • THMC en pacientes con inmunodeficiencia, hipertensin o enfermedad pulmonar (antecedentes de tabaquismo o EPOC de moderada a grave)
    • Efectos sobre los niveles de protena C reactiva (PCR)
    • Efectos sobre los niveles de ferritina.
    • Efectos sobre la lactato deshidrogenasa (LDH)
    • Listado y documentacin de frecuencia y gravedad de los efectos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mortality at day 28
    Rest of endpoints during the course of the study
    Mortalidad a los 28 das
    Restos de variables durante el curso del estudio
    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
    inclusión estratificada por: región y uso de terapias concomitantes
    enrollment stratified by: Region and Use of concomitant therapies
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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.
    Se considerará que un paciente ha completado el estudio si completa hasta 14 días de tratamiento (o 28 días a discreción del médico)
    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: 180
    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
    Patients in emergency situation due to COVID-19 infection and consent is not able to be obtained
    Pacientes en situación de urgencia debido a infección por COVID-19 y no se puede obtener el consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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.
    Tras el cese de la participación en el estudio de un paciente, el médico le ofrecerá el tratamiento más apropiado disponible
    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 Decision2020-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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