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    Summary
    EudraCT Number:2020-002102-58
    Sponsor's Protocol Code Number:TJT2012
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-06
    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 number2020-002102-58
    A.3Full title of the trial
    Mesenchymal stromal cell therapy for severe COVID-19 infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with stem cells for Patients with severe COVID-19 infection
    A.3.2Name or abbreviated title of the trial where available
    MSC therapy for severe COVID-19 infection
    A.4.1Sponsor's protocol code numberTJT2012
    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 SponsorCHU de Liège
    B.1.3.4CountryBelgium
    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 supportCHU de Liège
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Liège
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'Hôpital 1
    B.5.3.2Town/ cityLIEGE
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003243667201
    B.5.6E-mailyves.beguin@chuliege.be
    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 nameMesenchymal Stromal Cells
    D.3.2Product code MSC
    D.3.4Pharmaceutical form Suspension for injection
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with severe COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    Patients with coronavirus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory 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
    The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of MSC administration associated with the standard of care (SOC including anti-viral therapy) on:
    1. Clinical status (on a 7-point WHO ordinal scale)
    2. The need for mechanical ventilation and the duration of oxygen therapy and mechanical ventilation
    3. The length of stay at the intensive care unit and of hospitalization
    4. The number of organ failures
    5. The intensity of the inflammatory response
    6. Coagulation parameters
    7. Biomarkers of lung lesion, repair and scarring
    8. Viral load and sero-conversion
    9. Pulmonary function (pulmonary function tests and thoracic CT-scan)
    10. The number of Adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs/SUSARs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. COVID-19 patients:
    • Male or female patients aged at least 18 years and up to 70 years;

    • Diagnosed with microbiologically or radiologically confirmed COVID-19 pneumonia as defined by:
    - Extensive interstitial pneumonia on CT scan, consistent with viral pneumonia, within 10 days prior to randomization
    AND
    - Either positive result of COVID-19 PCR test within 14 days prior to inclusion
    OR positive result of SARS-CoV2 PCR or serology within 14 days after inclusion

    • Requiring oxygen administration (SpO2 ≤ 93% on room air):
    - Group A: in standard or intensive care unit requiring supplemental oxygen
    - Group B: in intensive care unit under mechanical ventilation administered through a tracheal tube, either:
    for less than or equal to 7 days
    OR
    for 7 to 14 days, with persisting high inflammation (ferritin > 2,000 µg/L; ferritin > 1,000 µg/L and rising; lymphocytes < 800 with CRP > 70 mg/L and rising or ferritin > 700 µg/L and rising or LDH > 300 UI/L or D-Dimers > 1000 ng/ml), not explained by superinfection. Rising = compared to previous 24H.

    • Written consent of the patient, or
    – if impossible (clinical condition precluding capacity to consent) - of his/her legal representative, or
    - if impossible - of an impartial witness such as a physician from a non-participating department or member of the Ethics Committee.
    Any consent obtained this way shall be documented and confirmed by way of normal consent procedures at the earliest opportunity when the patient has recovered.

    2. MSC donors:
    • Unrelated to the patient
    • Male or female
    • Age > 18 yrs
    • No HLA matching required
    • Fulfills generally accepted criteria for allogeneic HSC donation
    • Informed consent given by donor
    E.4Principal exclusion criteria
    1. COVID-19 patients:
    • Ongoing pregnancy. Women of childbearing potential (WOCBP, defined as a premenopausal female capable of becoming pregnant) should use an appropriate method of contraception (oral, injectable, or mechanical contraception; women whose partners have been vasectomized or have received or are utilizing mechanical contraceptive devices).
    • Extracorporeal membrane oxygenation
    • Limitations to intensity of care
    • Life expectancy < 24 hours
    • Known allergy to IMP component
    • Active secondary infection
    • Any malignancy (except non-melanoma skin carcinoma) within 2 years before inclusion
    • Pre-existing thrombo-embolic pathology
    • Signs of an active drug or alcohol dependence, serious current illness, mental illness or any factors which, in the opinion of the Investigator, may interfere with subject’s ability to understand and comply with study requirements
    • Patients with any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator’s judgment, precludes the patient’s safe participation in and completion of the study.
    • Participation in another clinical trial (use of anti-viral/supportive drugs for COVID-19 infection on a compassionate use basis is not an exclusion criterion).

    2. MSC donors:
    • Any condition not fulfilling inclusion criteria
    • Known allergy to lidocaine
    • Any risk factor for transmissible infectious diseases, in particular HIV
    E.5 End points
    E.5.1Primary end point(s)
    Safety co-primary endpoint:
    To evaluate the safety of intravenous infusions of BM-MSC in patients with severe to critical COVID-19 pneumonia:
    • Infusional toxicity (change in body temperature, heart rate, mean arterial blood pressure and peripheral capillary oxygen saturation, and clinical signs of allergy such as skin reaction or anaphylactic shock);
    • - Adverse events of special interest: Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events within the first 28 days after inclusion

    Efficacy co-primary endpoint:
    - Group A (patients not under mechanical ventilation): % patients requiring mechanical ventilation by day 28
    - Group B (patients under mechanical ventilation): Vital status (dead/alive) at day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety co-primary endpoint: within the first 28 days after inclusion

    Efficacy co-primary endpoint:
    - Group A : by day 28
    - Group B: at day 28
    E.5.2Secondary end point(s)
    To evaluate the effects of MSC administration associated with the standard of care (SOC including anti-viral therapy) on:
    1. Clinical status (on a 7-point WHO ordinal scale) over the 28 days after inclusion
    2. The need for mechanical ventilation and the duration of oxygen therapy and mechanical ventilation over the 28 days after inclusion
    3. The length of stay at the intensive care unit and of hospitalization
    4. The number of organ failures over the 28 days after inclusion
    5. The intensity of the inflammatory response during the 28 days following inclusion
    6. Coagulation parameters within the first 28 days following inclusion
    7. Biomarkers of lung lesion, repair and scarring within the first 28 days following inclusion
    8. Viral load over the 28 days after inclusion and sero-conversion to COVID-19 over the 90 days after inclusion
    9. Pulmonary function (pulmonary function tests and thoracic CT-scan) at day 90 after inclusion.
    10. The number of Adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs/SUSARs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    To evaluate the effects of MSC administration associated with the standard of care (SOC including anti-viral therapy) on:
    1. over the 28 days after inclusion
    2. over the 28 days after inclusion
    3. over the 90 days after inclusion
    4. over the 28 days after inclusion
    5. during the 28 days following inclusion
    6. within the first 28 days following inclusion
    7. within the first 28 days following inclusion
    8. Viral load over the 28 days after inclusion and sero-conversion to COVID-19 over the 90 days after inclusion
    9. at day 90 after inclusion.
    10. during all 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 No
    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
    After all data collection (freezed database) after last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days90
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alternative Inform Consent procedure to obtaine consent due to the situation (clinical trial during the COVID-19 pandemic)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    treatment or care NOT different from the expected normal treatment of that condition
    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 Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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