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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:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-03
    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 ConcernedAustria - BASG
    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
    Eine randomisierte Phase-II-Einzelblindstudie zur Beurteilung der Aktivität und
    Sicherheit von niedrig dosiertem oralem Selinexor (KPT-330) bei Patienten mit schwerer COVID-19
    Infektion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    Eine randomisierte Phase-II-Einzelblindstudie zur Beurteilung der Aktivität und
    Sicherheit von niedrig dosiertem oralem Selinexor (KPT-330) bei Patienten mit schwerer COVID-19
    Infektion
    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
    E.1.1.1Medical condition in easily understood language
    Severe infection caused by a novel 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 Scale Improvement (OSI)
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    -To evaluate improvement in clinical measures across the 2 treatment arms
    Additional secondary objectives:
    -To evaluate improvement in additional clinical measures across the 2 treatment arms
    -To determine the anti-inflammatory and immune effect of selinexor
    -To assess safety and tolerability of selinexor [time frame: up to 28 days]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all the following criteria:
    1.Age ≥18 years
    2.Confirmed laboratory diagnosis of SARS-CoV2 by standard - approved RT-PCR assay (local labs) within 7 days of enrollment
    3.Currently hospitalized
    4.Informed consent
    5.Has symptoms of severe COVID-19 as demonstrated by:
    a.At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress
    AND
    b. Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SaO2 <92% on room air in last 12 hours or requires ≥4 LPM oxygen by nasal canula, non-rebreather/Ventimask (or similar device) or high flow nasal canula in order to maintain SaO2≥92%, PaO2/FiO2 <300 mm/hg. Patients with COPD or chronic lung disease must demonstrate evidence of increased oxygen needs above baseline.
    6.Elevated CRP > 2 x ULN
    7.Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician’s judgement, it is in the best interest of the patient to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the patient’s chart and entered in the electronic case report form.
    Note: Patients who may have received plasma convalescent therapy > 48 hours prior to enrollment with no clinical improvement and who still meet criteria for severe COVID-19 may enroll. On study plasma convalescent therapy is not permitted. Patient who receive plasma convalescent therapy within 48 hours may be permitted to enroll based on discussion with sponsor.
    8.Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 8.3.1 of the protocol.
    E.4Principal exclusion criteria
    1.Evidence of critical COVID-19 based on:
    a.Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
    b.Septic shock (defined by investigator assessment or requiring vasopressors)
    c.Multiple organ dysfunction/failure
    2.In the opinion of the investigator, unlikely to survive for at least 48 hours from screening
    3.Inadequate hematologic parameters as indicated by the following labs:
    a.Patients with severe neutropenia (ANC <1,000 x 109/L) or
    b.Thrombocytopenia (e.g., platelets <100,000 per microliter of blood )
    4.Inadequate renal function and liver function as indicated by the following labs:
    a.creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault.
    b.Aspartate transaminase (AST) or alanine transaminase (ALT) >5x the upper limit of normal
    5.Unable to take oral medication when inform consent is obtained.
    6.Patients with a legal guardian or who are incarcerated.
    7.Pregnant and breastfeeding women
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with at least a 2 point improvement (increase) in the Ordinal Scale from baseline to Day 14.
    The Ordinal Scale is an assessment of the clinical status at the first assessment on each day of hospitalization.
    1.Death;
    2.Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    3.Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4.Hospitalized, requiring supplemental oxygen;
    5.Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    6.Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    7.Not hospitalized, limitation on activities and/or requiring home oxygen;
    8.Not hospitalized, no limitations on activities.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    •Time to recovery defined as improvement from baseline score of 3 to ≥4 or from a baseline score of 4 to ≥5
    •Proportion of patients with at least a 2 point improvement (increase) in the Ordinal Scale from baseline to Day 7.
    •Proportion of patients with at least a 1 point improvement (increase) in the Ordinal Scale from baseline to Day 7
    •Proportion of patients with at least a 1 point improvement (increase) in the Ordinal Scale from baseline to Day 14.
    •Time to an improvement of 2 point using WHO Ordinal Scale Improvement (TTCI-2)
    •Time to clinical improvement (TTCI-1): defined as the time from randomization, or lower score within 24 hours, to an improvement of 1 point on the Ordinal Scale)
    •Overall death rate on Day 28
    •Rate of mechanical ventilation

    Additional secondary endpoints:
    •Overall Survival
    •Overall death rate on Day 14
    •Rate of ICU admission
    •Length of hospitalization
    •Length of ICU stay
    •Duration of mechanical ventilation
    •PaO2:FiO2 and/or oxygenation index over time
    •Reduction of C-reactive protein (CRP)
    •Reduction in ferritin levels
    •LDH
    •Measure changes from baseline of blood plasma cytokines: IL-1β, IL-1Rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IFNγ, IP10, TNFα
    •Listing and documentation of frequency and severity of adverse effects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall death rate on Day 14 and Day 28
    Rest of endpoints during the course of the study
    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 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) 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
    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 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
    End of Study will occur when the last patient has completed the 30-day
    Safety follow up period (after their last dose of study treatment), has
    withdrawn consent or has died, whichever comes first.
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 300
    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.
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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