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    Summary
    EudraCT Number:2021-004259-17
    Sponsor's Protocol Code Number:NS3.1
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-28
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-004259-17
    A.3Full title of the trial
    A Phase IIb Randomized, Quadruple-blinded Multicenter, Multinational, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration in Patients with Moderate or Severe COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial for the safety and efficacy of exosomes that overexpress CD24 for preventing the deterioration of moderate or severe COVID-19
    A.4.1Sponsor's protocol code numberNS3.1
    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 SponsorOBCTCD-24 Ltd
    B.1.3.4CountryIsrael
    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 supportOBCTCD-24 Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOBCTCd-24 Ltd
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street Address165 Yarkon
    B.5.3.2Town/ cityTel Aviv
    B.5.3.3Post code6345323
    B.5.3.4CountryIsrael
    B.5.4Telephone number0097254-6241679
    B.5.6E-mailofer@covend24.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 nameCovenD24
    D.3.2Product code CovenD24
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNExo-CD24
    D.3.9.3Other descriptive nameExosomes expressing CD24
    D.3.9.4EV Substance CodeSUB224030
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000
    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 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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 disease
    E.1.1.1Medical condition in easily understood language
    COVID-19 disease
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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
    • To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 throughout the 28-day follow-up period.
    Primary Efficacy Objective:
    • To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19.
    E.2.2Secondary objectives of the trial
    •To evaluate the rate of respiratory failure
    •To evaluate the ratio of patients with the ability to be discharged from the hospital.
    •To evaluate the time to improvement
    •To evaluate the time to recovery (COVID-19 clinical severity score of 3 or lower).
    •To evaluate the rate of ICU admissions
    •To evaluate the time from hospitalization to hospital discharge.
    •To evaluate the clinical outcome throughout the study period using the WHO Ordinal Scale (OS)
    •To assess the COVID-19-related symptoms using patient-reported outcome (PRO) measure score
    • To evaluate the death rate.

    Exploratory Objectives:
    • To evaluate the effect of EXO-CD24 on the respiratory rate.
    • To evaluate the effect of EXO-CD24 on the blood oxygen saturation (SpO2).
    • To evaluate the effect of EXO-CD24 on the level of inflammatory markers
    • Blood samples for inflammatory and other biomarkers will be stored for future analyses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 viral infection positive polymerase chain reaction (PCR) test within 15 days from screening
    2. Age ≥18 years
    3. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
    a. Clinical and Imaging-based evaluation
    i. Respiratory rate > 23/min and < 30/min
    ii. SpO2 at room air ≤ 94% and ≥90%
    iii. Bilateral pulmonary infiltrates > 25% within 24-48 hours or a severe deterioration compared to imaging at admission
    b. Evidence of an exacerbated inflammatory process
    i. LDH score > 300 U/L or what is the upper limit for normal per age
    ii. CRP >25 mg/L
    iii. Ferritin >500 ng/ml
    iv. Lymphocytes <800 cells/mm3
    v. D-dimers >500ng/ml
    4. Willing and able to sign an informed consent.
    E.4Principal exclusion criteria
    1. Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency, HIV etc.).
    2. Patients with PO2< 60 at room air
    3. Patients with PO2/FiO2<150
    4. Patients with mechanical ventilation (ECMO), or NIV, or high flow nasal cannula) or using vasopressors or patients who will probably require ICU admission, mechanical ventilation, or the use of vasopressors within 24 hours from enrolment, according to the Investigator’s judgment
    5. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding
    6. Patient on long-term immunosuppression therapy, i.e., patient in active long-term inmmunosuppresion like rituximab
    7. Participation in any other Interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint:
    • Incidence of all adverse events by severity, related or unrelated to the study drug.
    Primary Efficacy Endpoint:
    • Rate of improvement of COVID-19 status on Day 7 (2 days post last therapy), transitioning from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using the 10-point COVID-19 clinical severity ordinal scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    After follow up period
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Rate of respiratory failure (defined as a PaO2<60 mmHg and/or a PaCO2>45 mmHg, or the need for mechanical ventilation, ECMO, NIV, or high-flow oxygen devices] within 28 days of the study period (Day 28).
    • The percentage of patients with the ability to be discharged from the hospital.
    • Time to improvement (transitioning from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using the 10-point COVID-19 clinical severity ordinal scale, measured from randomization (Day 1) to last study follow-up (Day 28).
    • Time to recovery, measured from randomization (Day 1) to recovery or last follow-up (Day 28), whichever comes first. Recovery is defined as achieving a COVID-19 clinical severity score of 3 or lower.
    • Percent of patients admitted to the intensive care unit (ICU) within 28 days of the study period.
    • Hospital discharge time within 28 days of the study period, calculated from the day of randomization (Day 1) to discharge or the last follow-up (Day 28), whichever comes first.
    • Percentage of patients reporting each severity rating on the OS within 28 days of the study period (Day 1 to Day 28).
    • Change from baseline in the COVID-19 clinical severity OS [before-treatment assessment (Screening/Day 1)] up to Day 28.
    • Change from baseline in the PRO score of the COVID-19-Related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment questionnaire (2).
    • Death rate at end of study (Day 28).
    Exploratory Endpoints:
    • Proportion of patients with respiratory rate < 23/min at every visit until Day 28, inclusive.
    • Change [decrease/no change (±2 breaths/min)/improvement] in the respiratory rate from baseline to Day 7 visit.
    • Proportion of patients with SpO2 saturation >94%, on room air, at every visit until Day 28, inclusive.
    • Change [decrease/no change (±2 %)/improvement] in the SpO2 saturation from baseline to Day 7 visit.
    • Proportion of patients with an increase from baseline of 25% in the absolute lymphocyte count, hours on Day 7.
    • Change in the absolute lymphocyte count from baseline to Day 7.
    • Proportion of patients with a decrease from baseline of 20% in the neutrophil-to-lymphocyte ratio (NLR) on Day 7.
    • Change from baseline to Day 7 in NLR.
    • Change from baseline in CRP/LDH/Fibrinogen/Ferritin/ from baseline on Day 7.
    • Blood samples for inflammatory and other biomarkers will be stored for future analyses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After follow up 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 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 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
    Quadruple-blinded
    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 concerned3
    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 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
    Israel
    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
    Last subject last visit
    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 months6
    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 months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 156
    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 Decision2022-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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