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    Summary
    EudraCT Number:2020-005299-36
    Sponsor's Protocol Code Number:EXEVIR0101
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-005299-36
    A.3Full title of the trial
    A 2-part Clinical Study Including a First-in-Human, Open-label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double-blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
    A.4.1Sponsor's protocol code numberEXEVIR0101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04884295
    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 SponsorExeVir Bio BV
    B.1.3.4CountryBelgium
    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 supportExeVir Bio BV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationExeVir Bio BV
    B.5.2Functional name of contact pointDominique Tersago
    B.5.3 Address:
    B.5.3.1Street AddressRijvisschestraat 120
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number32 (0)2899 87 37
    B.5.5Fax number32 (0)2 899 87 38
    B.5.6E-mailinfo@exevir.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 nameXVR011
    D.3.2Product code XVR011
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameXVR011
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeXVR011 is a bivalent single domain (heavy chain only) antibody fragment (VHH) which is linked to an effector function-silenced Fc part of a human IgG1.
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects hospitalised for COVID 19
    E.1.1.1Medical condition in easily understood language
    Subjects hospitalised for 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 LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    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
    art I
    To evaluate the safety of a single intravenous XVR011 infusion in subjects hospitalised for COVID 19

    Part II
    To evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalized for COVID-19, compared to placebo
    E.2.2Secondary objectives of the trial
    Part I
    - To evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19
    - To evaluate the antiviral activity of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19
    Part II
    - To further evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo
    - To evaluate the antiviral activity of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo
    - To evaluate the safety of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Is ≥18 years of age inclusive, at the time of signing the informed consent.
    - Has ongoing SARS-CoV-2 infection confirmed by positive RT-PCR test and/or positive antigen test in a timeframe consistent with the current symptoms.
    - Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable
    - Requires hospitalisation for medical care.
    - Has oxygen saturation ≥ 91% (via pulse oximetry) on room air at rest.
    - Informed Consent
    E.4Principal exclusion criteria
    - Has a resting respiratory rate >= 30 per minute, or heart rate ≥ 125 per minute at hospitalisation.
    - Has severe COVID-19 requiring non-invasive (e.g. high flow) or
    invasive mechanical ventilation and/or intensive care treatment.
    - Has ongoing clinically significant thromboembolic event or
    coagulopathy, according to clinical, laboratory and/or radiological
    assessment.
    - Has any other medical condition, which in the opinion of the
    Investigator, would impact the safety of the subjects.
    - Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days before study treatment start.
    - Has known allergy or hypersensitivity reaction to any monoclonal
    antibody or to any components of study treatment.
    - For WOCBP:
    o Pregnancy or a positive urine pregnancy test
    o Breastfeeding
    Exclusion Criteria only Applicable to Part 1
    - Has received or is receiving concomitant treatment with medicinal
    products with potential or demonstrated anti SARS CoV 2 (antiviral)
    activity, including but not limited to remdesivir, within 30 days prior to the study treatment administration.
    - Has renal impairment with estimated creatinine clearance < 60
    mL/min/1.73 m2 .
    - Has morbid obesity (body mass index > 35 kg/m2), uncontrolled
    diabetes, cardiac insufficiency, uncontrolled high blood pressure, or any clinically significant (in the opinion of the Investigator) hepatic,
    pulmonary, gastrointestinal, genitourinary, endocrine, immunologic,
    metabolic, neurologic, or haematological disease.
    E.5 End points
    E.5.1Primary end point(s)
    Part I:
    - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period
    - Proportion of subjects with AEs (all and serious) of any grade and independent of causality within 28-day FU period
    - Proportion of subjects with infusion related reactions within 24 hours of treatment
    - Proportion of subjects with hypersensitivity reactions within 28-day FU period
    Part II:
    - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part I and II:
    within 28-day FU period
    E.5.2Secondary end point(s)
    Part I
    - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point
    ordinal scale) within 28-day FU period
    - Total duration of oxygen supplementation within 28-day FU period
    - Proportion of subjects requiring mechanical ventilation within 28-day FU period
    - Proportion of subjects requiring ICU transfer within 28-day FU period- Time to hospital discharge
    - Proportion of subjects with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline
    - Proportion of subjects with COVID-19 related symptoms
    - All-cause mortality rate within 28-day FU period
    - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day3, Day 8 and day of discharge

    Part II
    - Total duration of oxygen supplementation within 28-day FU period
    - Proportion of subjects requiring mechanical ventilation within 28-day FU period
    - Proportion of subjects requiring ICU transfer within 28-day FU period- Time to hospital discharge
    - Proportion of subjects with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline
    - Proportion of subjects with COVID-19 related symptoms
    - All-cause mortality rate within 28-day FU period
    - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day 3, Day 8 and day of discharge
    - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period
    - Proportion of subjects with AEs (all and serious) of any grade and
    independent of causality within 28-day FU period
    - Proportion of subjects with infusion-related reactions within 24 hours of treatment
    - Proportion of subjects with hypersensitivity reactions within 28-day FUperiod
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part I:
    within 28-day FU period
    Part II:
    within 28-day FU period
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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
    Part 1 is open-label, single ascending dose. Part 2 is double-blind randomised, placebo-controlled
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Brazil
    Mexico
    South Africa
    United States
    Belgium
    France
    Italy
    Portugal
    Romania
    Spain
    United Kingdom
    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
    date of the last visit of the last participant in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 167
    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 No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 279
    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 the end of the study, no further treatment with XVR011 is expected. Subjects will continue receiving Standard Of Care treatment.
    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 Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-03-18
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