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    The EU Clinical Trials Register currently displays   43889   clinical trials with a EudraCT protocol, of which   7298   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:2020-006044-14
    Sponsor's Protocol Code Number:EB05-04-2020
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-006044-14
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + SOC vs. placebo + SOC in adult hospitalized patients with COVID19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EB05 + standard of care versus placebo + standard of care in adult hospitalized patients with COVID19
    A.4.1Sponsor's protocol code numberEB05-04-2020
    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 SponsorEdesa Biotech Research Inc.
    B.1.3.4CountryCanada
    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 supportEdesa Biotech Research Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJSS Medical Research Europe Sp. z o.o.
    B.5.2Functional name of contact pointJSS Medical Research Europe Sp. z o
    B.5.3 Address:
    B.5.3.1Street AddressAl. Jana Pawła II 29
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code00-867
    B.5.3.4CountryPoland
    B.5.4Telephone number+48509942244
    B.5.6E-mailjakub.srednicki@jssresearch.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 nameEB05
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNThere is no recommended International Non-proprietary Name
    D.3.9.3Other descriptive nameNI-0101
    D.3.9.4EV Substance CodeSUB187569
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to +/- 15
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2 Positive Pneumonia - level 3-7 in the nine-point COVID-19 severity scale:
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 Positive Pneumonia
    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 10084380
    E.1.2Term COVID-19 pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084383
    E.1.2Term Novel COVID-19-infected pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Study
    Primary Objective
    To evaluate the clinical efficacy of EB05 + SOC vs. Placebo + SOC in adult hospitalized patients with COVID-19 that are classified Level 6 and Level 7 WHO COVID-19 Severity Scale.
    E.2.2Secondary objectives of the trial
    Secondary Objective
    To evaluate the safety of EB05 in adult hospitalized patients with COVID-19 that are classified as Level 6 or Level 7 on the WHO COVID-19 Severity Scale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Study:
    All the following criteria need to be met for inclusion:
    1. Men and women ≥18 years of age at the time of consent.
    2. Laboratory-confirmed diagnosis of COVID-19.
    3. Hospitalized for COVID-19 related respiratory disease.
    4. Patient belongs to one of the following four categories in the nine-point COVID-19 severity scale:
    • Hospitalized, requiring intubation and mechanical ventilation- Level 6 of the nine-point COVID-19 severity scale. (Cohort 1)
    • Hospitalized, and intubated with additional organ support – pressors, RRT, ECMO – Level 7 of the nine-point COVID-19 severity scale. (Cohort 2)
    5. For women of childbearing potential: negative pregnancy test and agreement to remain
    abstinent or to use highly effective contraceptive methods during the study, and for 11
    weeks after the study drug administration (five half-lives). The reliability of sexual
    abstinence needs to be evaluated in relation to the duration of the clinical trial and the
    preferred and usual lifestyle of the participant.
    These include:
    • Combined (estrogen and progestogen containing) hormonal contraception
    associated with inhibition of ovulation
    - oral
    - intravaginal
    - transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation
    - oral
    - injectable
    - implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomised partner 1
    • Sexual abstinence 2
    Note: A woman of non-childbearing potential is defined as follows:
    • Age ≥60 years of age
    • Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral
    salpingectomy);
    • Has had a cessation of menses for at least 12 months without an alternative medical
    cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing
    potential (refer to laboratory reference ranges for confirmatory levels).
    6. For men with female partners of childbearing potential: agreement to remain abstinent or
    use adequate contraceptive methods by yourself or your partner, as applicable, during study
    duration, and for 11 weeks after the study drug administration (five half-lives).
    These include:
    • Combined (estrogen and progestogen containing) hormonal contraception
    associated with inhibition of ovulation
    - oral
    - intravaginal
    - transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation
    - oral
    - injectable
    - implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    • Vasectomised partner
    • Sexual abstinence
    • progestogen-only oral hormonal contraception, where inhibition of ovulation is
    not the primary mode of action
    • male or female condom with or without spermicide
    • cap, diaphragm or sponge with spermicide
    7. Informed consent obtained from any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives.
    E.4Principal exclusion criteria
    Patients will be excluded if any of the following criteria are met:
    1. The subject is a female who is breastfeeding or pregnant.
    2. Known hypersensitivity to EB05 or its excipients.
    3. In the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment.
    4. Experiencing cardiac arrest while hospitalized with COVID-19.
    5. Active participation in other immunomodulator or immunosuppressant drug clinical trials.
    6. Treatment with immunomodulator or immunosuppressant drugs, including but not limited to TNF inhibitors and antiIL-1 agents, within 5 half-lives or 30 days
    (whichever is longer) before randomization. (Note treatment with
    immunomodulator or immunosuppressant drugs, such as
    corticosteroids, as part of SOC, is permitted).
    7. Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgement of the clinician.
    8. Patients that are discharged alive or die within the first 3 days
    after randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    There are two independent primary efficacy endpoints that will depend on the patient cohort.

    Cohort 1: WHO COVID – SEVERITY SCALE LEVEL 6: Invasive Mechanical Ventilation
    Ventilator-Free Days (VFD), defined as being alive and free from mechanical ventilation at Day 28 from IP administration.

    Cohort 2: WHO COVID – SEVERITY SCALE LEVEL 7: Critically- Ill
    The mortality rate at Day 28 from IP administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 Day
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Time to discharge from IP administration.
    • The proportion of patients who are discharged by Day 28 from IP administration.
    • The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 28 from IP administration
    • The proportion of patients with clinical improvement, defined as a decrease of two points or more on the WHO 9 – point ordinal scale at Day 60 from IP administration.
    • Time to clinical improvement by 2 points on the WHO ordinal scale described above from IP administration.
    • Days alive and ventilator-free at Day 28 from IP administration (Cohort 2 only)
    • Days alive and free of organ support at Day 28 from IP administration.
    • Days alive and ventilator-free at Day 60 from IP administration.
    • Days alive and free of organ support at Day 60 from IP administration.
    • The mortality rate at Day 28 from IP administration (Cohort 1 only)
    • The mortality rate at Day 60 from IP administration.
    • Duration of hospitalization from IP administration.
    • Duration of ICU stay from IP administration.
    • Change in Berlin ARDS classification from IP administration.
    Safety Endpoint:
    The number of treatment-emergent adverse events (TEAEs) and serious TEAEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Endpoints and safety Endpoints: Please refer to protocol
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned7
    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
    Canada
    Colombia
    United States
    Poland
    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
    The end of study is defined as the shortest between time of discharge from the hospital or Day 28 assessment as shown in the schedule of events
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 975
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 526
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 1501
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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