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    Summary
    EudraCT Number:2020-001571-32
    Sponsor's Protocol Code Number:APHP200406
    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:2020-04-07
    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 number2020-001571-32
    A.3Full title of the trial
    Low dose of IL-2 In Acute respiratory DistrEss syndrome related to COVID-19 LILIADE-COVID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low dose of IL-2 In Acute respiratory DistrEss syndrome related to COVID-19
    A.3.2Name or abbreviated title of the trial where available
    LILIADE-COVID
    A.4.1Sponsor's protocol code numberAPHP200406
    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 SponsorAssistance Publique Hôpitaux de Paris
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique Hôpitaus de Paris
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0140275009
    B.5.5Fax number0144841701
    B.5.6E-maileunice.nubret@aphp.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 nameAldesleukin
    D.3.2Product code ILT101
    D.3.4Pharmaceutical form Concentrate for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 110942-02-4
    D.3.9.2Current sponsor codeILT101
    D.3.9.3Other descriptive nameALDESLEUKIN
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboConcentrate for cutaneous solution
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID 19 POSITIVE
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of low-dose interleukin 2 (Ld-IL2) administration in improving clinical course and oxygenation parameters in patients with SARS-CoV2-related ARDS.

    E.2.2Secondary objectives of the trial
    To assess the safety of low dose interleukin-2 (Ld-IL2) compared with placebo
    -To demonstrate that Ld-IL2 improves the components of the composite endpoint of mortality and duration of mechanical ventilation.
    -To demonstrate that Ld-IL2 shortens SARS-CoV2-related ARDS resolution
    -To demonstrate that Ld-IL2 shortens mechanical ventilation weaning process in SARS-CoV2-related ARDS
    -To demonstrate that Ld-IL2 reduces nursing workload, rate of prone positioning
    -To demonstrate that Ld-IL2 reduces the number of days alive in hospital during 28 days
    -To demonstrate that Ld-IL2 reduces the number of organ dysfunctions

    - Exploratory objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, age ≥ 18 years
    - Laboratory (RT-PCR) confirmed infection with SARS-CoV2
    - Patient is intubated and mechanically ventilated
    - Diagnosis of ARDS according to the Berlin definition of ARDS
    - Onset of ARDS <96 hours
    - Patient with French Social Security System
    - A written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator’s decision alone.
    E.4Principal exclusion criteria
    1. Previous history of ARDS in the last month
    2. Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
    3. Allogeneic bone marrow transplantation
    4. Active cancer
    5. Liver cirrhosis with basal Child and Pugh of C
    6. Pulmonary fibrosis
    7. Patient with end-of-life decision
    8. Patient not expected to survive for 24 hours
    9. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
    10. Patient already enrolled in another interventional pharmacotherapy protocol
    on COVID-19
    11. Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients
    12. Patient with burns to ≥ 15% of their total body surface area
    13. Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
    14. Patient under legal protection (protection of the court, or in curatorship or guardianship).
    E.5 End points
    E.5.1Primary end point(s)
    The PaO2/FiO2 ratio at D7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    E.5.2Secondary end point(s)
    Changes in Tregs between Baseline and Day 7 (expressed in %)
    • - Number of days alive with oxygen therapy within 28 days
    • - Maximal oxygen rate within 28 days
    • - Number of days alive free of invasive or non-invasive ventilation within 28 days
    • - Number of days alive outside ICU within 28 days
    • - Number of days alive outside hospital within 28 days
    • - Time (in days) from randomization to death
    • - Mortality rate at D28
    • - Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)
    • - Use of antibiotics for respiratory (proved or suspected) infection within 28 days
    • - Number of prone positioning sessions

    Immunomonitoring study.
    Changes in Tregs and in other immunological, inflammatory or cellular parameters during the different visits between baseline and day 28 will be analyzed using ANOVA for ranks considering factor time and treatment .The antiviral TCR identified in BAL will be compare the TCR identified in blood by Mann-Whitney test. Multivariate methods will be used to identify relationships between immune-inflammatory profiles and clinical outcomes of the study.
    • Tregs percentages and numbers during induction period and throughout the follow up period at day 5, 7, 11, 14 and 28 compared to baseline before the first IL-2 injection.
    • Deep Immunophenotyping of immune cells at Day 7, and Day 14 compared to baseline
    • Cytokines and other solubles markers at Day 7, and Day 14 compared to baseline.
    • T cell repertoire on Treg, CD4 and CD8 Teff after sorting from blood at Day 7 and Day 14 and compared to baseline
    • Single cells sequencing will be performed in BAL at Day 7 and Day 14 and compared to baseline.

    E.5.2.1Timepoint(s) of evaluation of this end point
    see protocol v1.0
    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 No
    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 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 concerned6
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    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 Decision2020-04-15
    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 StatusOngoing
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