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    Summary
    EudraCT Number:2022-001152-42
    Sponsor's Protocol Code Number:ShaperonC002
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-04-06
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2022-001152-42
    A.3Full title of the trial
    A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
    A.4.1Sponsor's protocol code numberShaperonC002
    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 SponsorShaperon, Inc.
    B.1.3.4CountryKorea, Republic of
    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 supportShaperon, Inc.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHungaroTrial Zrt.
    B.5.2Functional name of contact pointMatyas Petho
    B.5.3 Address:
    B.5.3.1Street AddressFehervari ut 89-95.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1119
    B.5.3.4CountryHungary
    B.5.4Telephone number+3612032134
    B.5.6E-mailmpetho@hungarotrial.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 nameNuSepin
    D.3.2Product code HY-209
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium taurodeoxycholate
    D.3.9.1CAS number 1180-95-6
    D.3.9.2Current sponsor codeHY209
    D.3.9.3Other descriptive nameSodium taurodeoxycholate
    D.3.9.4EV Substance CodeSUB216434
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 Pneumonia Patients
    E.1.1.1Medical condition in easily understood language
    COVID-19 Pneumonia Patients
    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
    1. To determine the dose and dosage for intravenous administration to be applied in the NuSepin® phase 3 clinical trial by measuring the time to a 2-point reduction on the WHO 8-point ordinal scale. [Phase 2b]
    2. To examine superiority of intravenous administration of NuSepin® compared to placebo in hospitalized patients with COVID-19 pneumonia by measuring the time to discharge [Phase 3]
    E.2.2Secondary objectives of the trial
    To evaluate the effect of intravenous NuSepin® administration on
    - the improvement of clinical status compared to the control group
    - the improvement of illness severity over time based on vital signs (NEWS2) compared to the control group.
    - the use of oxygen ventilatory assistance (facial mask, low-flow oxygen cannula, high-flow oxygen cannula, Non-invasive ventilation, Invasive Mechanical Ventilation/ECMO) compared to the control group.
    - a shortening of hospitalization (ICU) period compared to the control group.
    - the survival compared to the control group.
    - the inflammatory markers compared to the control group
    - the improvement of cytokine release syndrome compared to the control group.
    - the viral burden compared to the control group.

    To evaluate drug compliance of intravenous administration of NuSepin®

    To evaluate the overall safety of NuSepin®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) An individual who has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent
    2) An adult man or woman aged 19 years (or age of majority in his/her country) and older.
    3) A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
    4) At the time of randomization; and whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale
    5) Pneumonia that satisfies all the following criteria at the time of randomization
    (1) Confirmation of Lung infiltration (chest x-ray, CT, etc. within 48 hours before randomization)
    (2) Patients with SpO₂≤94% at room air condition or on oxigen therapy
    6) Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection)
    7) A score of 5 points or more (“think sepsis”) on the NEWS 2 scale at the time of randomization
    E.4Principal exclusion criteria
    1) A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization
    2) An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization
    3) A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
    4) A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
    5) Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
    6) Any of the following laboratory test results at the time of screening:
    (1) Alanine aminotransferase (ALT) exceeding the upper normal limit (UNL) by 5 times
    (2) Aspartate aminotransferase (AST) exceeding the upper normal limit (UNL) by 5 times
    (3) Total bilirubin exceeding the upper normal limit by 3 times
    7) An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV)
    8) A patient with any of following infectious diseases (e.g., active tuberculosis, etc.) in the past or at present

    (2) A patient is diagnosed to have a respiratory viral or bacterial infection including active tuberculosis and excluding SARS-CoV-2 within 14 days prior to screening (However, those who have initially received a systemic antiinfective therapy based on clinical suspicion of a non-SARSCoV-2 infectious disease are allowed to participate in the trial, only when definitive diagnosis of SARS-CoV-2 infection is made.)
    9) A patient who uses mechanical ventilation (invasive or non-invasive) or oxygen therapy due to chronic lung diseases or neuromuscular disorders
    10) A patient who requires oxygen therapy due to lung diseases other than COVID-19 pneumonia (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, cystic pulmonary disease, etc.), congestive heart failure (NYHA Class 3 or 4), pulmonary edema, etc.
    11) An individual with a past medical history of hypersensitivity to the IMP and the standard therapies (Remdesivir, etc.) as well as to any ingredients of such drugs
    12) An individual who has received any of the prohibited medications within the protocol-specified timeframes of enrollment in the clinical trial (e.g., live vaccines within 4 weeks of screening)
    13) A woman with childbearing potential who has tested positive in the pregnancy test performed before participating in the clinical trial
    14) Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP not agreeing to ① use a highly effective method of contraception (hormonal contraceptives, intrauterine device (IUD), intrauterine system (IUS), vasectomy, intubation ligation, etc.); or use a double barrier method of contraception if the highly effective method is not possible (A combination between male condoms, female condoms, cervical caps, contraceptive diaphragms, and contraceptive sponges) during the course of the trial (until EOS visit); or ② donate the sperm until one month after the completion of the trial.
    15) A patient who is expected to be discharged or transferred within 72 hours
    16) A patient with less than 24 hours of life expectancy
    17) An individual who is currently participating in another clinical trial, or who received other study drugs as part of another clinical study within 2 months before the first dosing of the IMP (The last day of participating the previous another trial corresponds to the last dosing day of the other study drugs. Day 1 corresponds to the day after the last dosing day of the study drugs.)
    18) An individual judged by the investigator that would be ineligible to participate in the study for any other reasons
    E.5 End points
    E.5.1Primary end point(s)
    - Time to improvement of at least 2 categories relative to the first dosing date of the IMP (randomization date*) on an 8-point ordinal scale (WHO 8-OS) of clinical status up to day 29 [Phase 2b]
    - Time to discharge, relative to the first dosing date of the IMP (randomization date*) [Phase 3]
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Every day from Day 2 to Day 14 during hospitalization period
    - Day 15 (EOT)
    - Day 29 (EOS)
    E.5.2Secondary end point(s)
    Endpoints related to WHO 8-point ordinal scale
    1) The proportion of subjects with categories of 2 or less (outpatient condition); and 3 or less (hospitalized, no oxygen treatment) at day 8, 15 and 29
    2) The proportion of subjects with a decrease (improvement) of at least 2 categories on day 8, 15 and 29
    3) Time to clinical recovery (categories of 1 or less according to WHO 8-OS)
    4) Time to clinical improvement (a decrease (improvement) of at least 2 categories) on an 8-point ordinal scale (WHO 8-OS) of clinical status (only for phase 3)
    5) Time to discharge relative to the first dosing date of the IMP (randomization date) (only for phase 2)

    Endpoints related to NEWS 2
    6) Time to normalization of vital signs that lasts 24 hours or more (score 0 on NEWS2 that lasts 24 hours or more)
    7) The proportion of subjects with a NEWS2 of 0 on day 8, 15 and 29
    8) The proportion of subjects with a NEWS2 of 2 or less on day 8, 15 and 29
    9) The proportion of subjects with a decrease of at least 2 points relative to baseline on a NEWS2 at days 8, 15, and 29
    10) The proportion of subjects with a decrease by at least 15% relative to baseline on a NEWS2 at day 8, 15, and 29
    11) The proportion of subjects with a decrease by at least 30% relative to baseline on a NEWS2 at day 8, 15, and 29
    12) The proportion of subjects with a decrease by at least 60% relative to baseline on a NEWS2 at day 8, 15, and 29

    Endpoints related to the use of ventilatory assistance
    13) The proportion of subjects undergoing a ventilatory assistance (facial mask, low-flow oxygen cannula, high-flow oxygen cannula, Non-invasive ventilation, Invasive Mechanical Ventilation/ECMO) at day 8, day 15, and day 29; and the days of each ventilatory assistance since the first dosing date of IMP (randomization date) up to day 29

    Endpoints related to Hospitalization and ICU Admission
    14) Proportion of subjects transferred to ICU and the duration of ICU admission (date of admission to ICU ~ discharge date) since the first dosing date of IMP (randomization date) up to day 29
    15) Time from ICU to inpatient bed since the first dosing date of IMP (randomization date) (i.e., days of ICU admission; date of admission to ICU ~ ward transfer date)

    Endpoints related to Survival
    16) All-cause mortality; follow-up until discharge, or up to 60 days for patients who are still hospitalized at day 29 of the first IMP dosing (randomization date)

    Endpoints related to biomarkers
    17) Proportions of subjects whose inflammatory-related biomarkers at baseline, day 4, day 8, day 15, day 29 are within the normal range (① TNF-α, ② IL-1β, ③ IL-6, ④ IL-8 ⑤ IL-18 ⑥ CRP)
    18) Proportions of subjects with a decrease of inflammatory-related biomarkers by at least 30% relative to baseline at day 4, day 8, day 15, and day 29
    19) Blood concentrations and their changes from baseline of the inflammatory-related biomarkers thereof at day 4, day 8, day 15, and day 29

    Endpoints related to Cytokine release syndrome
    20) The proportion of subjects with a decrease of at least 1 category according to an ASTCT Consensus Grading step for Cytokine Release Syndrome

    Endpoints related to Viral burden
    21) Proportion of patients who become negative for viral titer at each assessment time point since the first dosing date of IMP
    22) Viral mRNA titers [qPCR quantitative analytes] at each assessment time point since the first dosing date of IMP
    23) Rates of reduction in viral mRNA titer [qPCR quantitative analytes] at each assessment time point since the first dosing date of IMP
    24) Proportion of patients with at least 1/2-log reduction of viral mRNA titer [qPCR quantitative analytes] at each assessment time point since the first dosing date of IMP
    25) Proportion of patients with at least 1-log reduction of viral mRNA titer [qPCR quantitative analytes] at each assessment time point since the first dosing date of IMP

    Endpoints related to Compliance
    26) Compliance of the study drugs (days of dosing with the study drugs and total dose administered)

    Safety Endpoints
    1) The incidence and characteristics of adverse events after administration of IMP (appearance, seriousness, results, etc.)
    2) Physical examination, vital signs, and clinical laboratory test results related to IMP administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Every day from Day 2 to Day 14 during hospitalization period
    - Day 15 (EOT)
    - Day 29 (EOS)
    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) 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 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 trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Korea, Republic of
    Bosnia and Herzegovina
    North Macedonia
    Serbia
    Bulgaria
    Croatia
    Romania
    Slovakia
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 334
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1134
    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)
    Standard care
    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 Decision2023-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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