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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002574-27
    Sponsor's Protocol Code Number:RC20_0230
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002574-27
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled phase 2a and 2b study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia
    Etude de phase 2a et 2b randomisée en double aveugle, contrôlée par placebo pour évaluer la sécurité et l'efficacité du XAV-19 chez des patients atteints de pneumonie modérée à COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia
    Etude pour évaluer la sécurité et l'efficacité du XAV-19 chez des patients COVID-19 atteints de pneumonie modérée à COVID-19
    A.3.2Name or abbreviated title of the trial where available
    POLYCOR
    POLYCOR
    A.4.1Sponsor's protocol code numberRC20_0230
    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 SponsorNantes CHU
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBPI
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportXenothera
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNantes CHU
    B.5.2Functional name of contact pointLaëtitia Berly
    B.5.3 Address:
    B.5.3.1Street Address5 Allée de l'ile Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253526204
    B.5.5Fax number0033253482836
    B.5.6E-mailbp-prom-regl@chu-nantes.fr
    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 nameXAV-19
    D.3.2Product code XAV-19
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Yes
    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 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
    Moderate COVID-19
    COVID-19 de forme modérée
    E.1.1.1Medical condition in easily understood language
    COVID-19
    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 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2a:
    The primary objective of the study is to evaluate the Antibody titers of
    XAV-19 treated patients versus placebo treated patients at Day 8.
    Phase 2b:
    The primary objective of the study is to compare duration until weaning
    supplemental oxygen in the two groups of treatment.
    E.2.2Secondary objectives of the trial
    Phase 2a:
    a)Characterize pharmacokinetics (PK) of XAV-19 infected patients over
    the time from D1 to D29
    b)Evaluate the Antibody titers of XAV-19 and to compare Group 1
    treated patients versus Group 2 treated patients at Day 8.
    c)Assess safety and tolerability of XAV-19 vs. placebo and between
    group 1 and group 2 treated patients over 29 days.
    d)Describe groups of patients according to clinical variables
    Phase 2b:
    a)Evolution of National Early Warning Score (NEWS)
    b)Changes in the 7-point ordinal scale between baseline and Day 15
    c)Improvement of one category from admission using the 7-point ordinal
    scale
    d)Normalization of fever
    e)Duration of oxygen therapy over 29 days
    f)Oxygen requirement over 29 days
    g)Transfer to ICU with need for IMV or high flow O2
    h)Hospital length of stay
    i)All cause of mortality
    j)Safety of XAV-19
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Only for Phase 2b
    Pharmacokinetic Study (20 patients)
    1.Objective
    The objective of the pharmacokinetic study is to characterize
    pharmacokinetics (PK) of XAV-19 infected patients over the time from
    D1 to D29.
    2.Endpoint
    Pharmacokinetic analysis correspond to antibody titer measurements at
    Day 1 (pre-dose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day
    15, and Day 29.
    Immunomonitoring Study (30 patients)
    1.Objective
    Objectives will be to assess the effects of neutralizing antibodies use on
    virus-induced immune response on longitudinal follow-up, and to
    identify targets for "immuno-monitoring" for the next phase of the study
    and to investigate the immunogenicity of COVID-19 during treatment
    with XAV19.
    2.Endpoint
    The endpoints encompass the following analysis:
    -Spike/ACE2 neutralizing antibody titers: D1 (pre-, post dose), D3, D5
    (pre- post dose), D8, D15 and D29
    -Lymphocytes sub-population: D1, D3, D5, D8 and D15
    -Transcriptomic analyses: D1, D3, D5, D8 and D15
    -Cytokines: D1, D3, D5, D8 and D15
    E.3Principal inclusion criteria
    1.Willing and able to provide written informed consent prior to
    performing study procedures
    2.Male or female ≥ 18 years
    3.Hospitalized for COVID-19
    4.Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx,
    saliva, sputum) ≤ 10 days before enrolment
    5.Evidence of pulmonary involvement (on lung examination
    [rales/crackles] and/or chest-imaging [Chest X-ray or computed
    tomography])
    6.Requiring O2 supplement with SpO2 ≤ 6L/min at screening
    7.Requiring O2 supplementation with SpO2 ≥ 94% on O2 therapy at
    screening
    8.First onset of COVID-19 symptoms ≤ 10 days, among fever and/or
    chills, headache, myalgias, cough, shortness of breath, whichever as
    occurred fist
    9.WOCBP must have a negative urinary pregnancy test the day of
    inclusion
    10.All sexually active male subjects must agree to use an adequate
    method of contraception throughout the study period and for 90 days
    after the last dose of study drug and agree to no sperm donation until
    the end of the study, or for 90 days after the last dose of XAV-19,
    whichever is longer
    11.Patients with French social security
    E.4Principal exclusion criteria
    1.Evidence of multiorgan failure (severe COVID-19)
    2.Mechanically ventilated (including ECMO)
    3.Receipt of immunoglobulins or any blood products in the past 30 days
    4.Psychiatric or cognitive illness or recreational drug/alcohol use that in
    the opinion of the investigator, would affect subject safety and/or
    compliance
    5.End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
    6.Child-Pugh C stage liver cirrhosis
    7.Decompensated cardiac insufficiency
    8.Known allergy, hypersensitivity, or intolerance to the study drug, or to
    any of its components
    9.Females of childbearing potential without contraceptive method, or
    with positive pregnancy test, breastfeeding, or planning to become
    pregnant during the study period
    10.Current documented and uncontrolled bacterial infection.
    11.Prior severe (grade 3) allergic reactions to plasma transfusion
    12.Patient participating in another interventional clinical trial
    13.Life expectancy estimated to be less than 6 months
    14.Patient under guardianship or trusteeship
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2a:
    The primary endpoint is pharmacokinetic measurement of the antibody
    titer of XAV-19 measurements of all treated patients and of all patients
    in the placebo group at Day 8 (3 days after the last administration).
    Phase 2b:
    Time to weaning of supplemental oxygen.
    If patient is still on oxygen at D15 or if the patient is weaned but put
    back on oxygen then the delay will be censored at 15 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 2a: Day 8
    Phase 2b: Day 15
    E.5.2Secondary end point(s)
    Phase 2a:
    The secondary endpoints are :
    a)Pharmacokinetic analysis: Antibody titer measurements at Day 1 (predose,
    post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day
    29.
    b)The antibody titer of XAV-19 measurements in Group 1 treated
    patients and Group 2 treated patients at Day 15.
    c)Safety of XAV-19 evaluated as:
    •Occurrence of all suspected XAV-19 related adverse effects and
    incidence of serious adverse events
    •Proportion of participants with treatment emergent adverse events
    leading to study drug discontinuation
    •Incidence of major or bacterial or fungal infections
    •Incidence of hypersensitivity reactions and infusion reactions
    •White cell count, hemoglobin, platelets, creatinine, ALT, AST, on D1, D3,
    D5, D8, D15 and D29
    •SARS-CoV-2 viral load over time (D1-D29), as collected by
    nasopharyngeal swab samples
    •Time to RT-PCR virus negativity in nasopharyngeal swab samples
    d)Clinical aspects:
    •Duration of supplemental oxygen
    •Transfer to intensive care unit with need for invasive mechanical
    ventilation or high flow oxygen
    •Normalization of fever ≥ 24 hours: clinical assessment every day from
    Day 1 to Day 14. Evaluation to be performed between 8 and 12 am, Day
    X evaluation will consider the higher value during Day X-1 (8 am to 8
    am)
    - Normal fever (≤ 37.8° C tympanic or ≤ 36.6°C axillary or ≤ 37.2°C oral
    taken 4 hours apart from antipyretic administration) each day and time
    to resolution of fever for at least 48 hours
    •Biomarkers : CRP, Ferritin
    •Ordinal scale assessed at Day 15. The 7-point ordinal scale is an
    assessment of the clinical status at the first assessment on day 15. The
    scale is as follows:
    1.Not hospitalized, no limitations on activities;
    2.Not hospitalized, limitations on activities;
    3.Hospitalized, not requiring supplemental oxygen;
    4.Hospitalized, requiring supplemental oxygen;
    5.Hospitalized, on non-invasive ventilation or high flow O2 devices;
    6.Hospitalized, on invasive mechanical ventilation or ECMO;
    7.Death.
    •Hospital length of stay

    Phase 2b:
    The secondary endpoints are:
    a)National Early Warning Score (NEWS) at Day 15 and every Day
    between D1 and D15
    b)Clinical status using the 7-point ordinal scale assessed at D3,D5, D8,
    D11, D15, and D29
    c)Time to improvement of one category from admission using the 7-
    point ordinal scale
    d)Time to first fever normalization (criteria for normalization:
    temperature < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal or
    tympanic)
    e)Duration of oxygen therapy over 29 days
    f)Oxygen requirement <4L/min or >4L/min to achieve a SpO2 > 94%
    between the two groups over 29 days
    g)Incidence and duration of non-invasive ventilation or high flow oxygen
    devices, of invasive mechanical ventilation during the study
    h)Hospital length of stay
    i)All cause mortality at D29
    j)Safety of XAV-19 evaluated as:
    •Occurrence of all suspected XAV-19 related adverse effects
    or Incidence of serious adverse events
    •Proportion of participants with treatment emergent adverse events
    leading to study drug discontinuation
    •Incidence of major or opportunistic bacterial or fungal infections
    •Incidence of hypersensitivity reactions and infusion reactions
    •White cell count, hemoglobin, platelets, creatinine, ALT, AST, on D1, D3,
    D5, D8, D11, D15 and D29
    •SARS-CoV-2 viral load over time (D1-D29), as collected by
    nasopharyngeal swab samples
    •Time to RT-PCR virus negativity in nasopharyngeal swab samples
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 2a:
    a)Pharmacokinetic analysis: at Day 1 (pre-dose, post-dose), at Day 5
    (pre-dose, post-dose), Day 8, Day 15, and Day 29.
    b)The antibody titer of XAV-19 measurements at Day 15.
    c)Safety of XAV-19 evaluated at every visit
    d)Clinical aspects at every visit
    Phase 2b:
    a)NEWS every Day between D1 and D15
    b)Clinical status assessed at D3,D5, D8, D11, D15, and D29
    c)Time to improvement using the 7-point ordinal scale at every visit
    d)Time to first fever normalization at every visit
    e)Duration of oxygen therapy at every visit
    f)Oxygen requirement at every visit
    g)Incidence and duration of non-invasive ventilation or high flow oxygen
    devices at every visit
    h)Hospital length of stay at every visit
    i)All cause mortality at D29
    j)Safety of XAV-19 evaluated at every visit
    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 Yes
    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 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 concerned35
    E.8.5The trial involves multiple Member States No
    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 No
    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 trial correspond to the end of analysis for the ancillary 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 months6
    E.8.9.1In the Member State concerned days
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 276
    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 state368
    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
    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 Decision2020-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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