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    Clinical Trial Results:
    A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in Covid-19 pneumonia patients

    Summary
    EudraCT number
    		 2020-003107-34
    Trial protocol
    		 RO  
    Global end of trial date
    05 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2022
    First version publication date
    26 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHAPERON001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04565379
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shaperon Inc.
    Sponsor organisation address
    174-10 Jagok-ro, Gangnam-gu, Seoul, Korea, Republic of,
    Public contact
    Clinical Trial Desk, Shaperon Inc, ctdesk@shaperon.com
    Scientific contact
    Clinical Trial Desk, Shaperon Inc, ctdesk@shaperon.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of efficacy of NuSepin® intravenous infusion in patients with SARS-CoV-2 infection
    Protection of trial subjects
    Subject safety, well-being and data integrity was protected by compliance with the study Protocol, GCP and local regulations and guidelines throughout the study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    44
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible subjects were undergone screening tests and procedures after signature of Patient Information Sheet and the Informed Consent Form. The procedures were include collecting demographic information, medical history, previous and concomitant medication, measurement of vital signs, a physical examination, routine laboratory exam, etc.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Dedicated unblinded site staff (pharmacists) were assigned at each site to prepare the IP infusions. All other team members, and all subjects, were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NuSepin 0.1 mg/kg
    Arm description
    		 NuSepin powder dissolved and diluted for infusion at 0.1 mg/kg in 100 ml NaCl solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NuSepin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NuSepin powder dissolved and diluted for infusion at 0.1 mg/kg in 100 ml NaCl solution.

    Arm title
    		 NuSepin 0.2 mg/kg
    Arm description
    		 NuSepin powder dissolved and diluted for infusion at 0.2 mg/kg in 100 ml NaCl solution.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NuSepin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NuSepin powder dissolved and diluted for infusion at 0.2 mg/kg in 100 ml NaCl solution.

    Arm title
    		 Placebo
    Arm description
    		 Placebo infusion of standard 100 ml NaCl solution.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    100 ml normal saline infusion as placebo

    Number of subjects in period 1
    		NuSepin 0.1 mg/kg NuSepin 0.2 mg/kg Placebo
    Started
    22
    22
    20
    Completed
    18
    21
    18
    Not completed
    4
    1
    2
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    2
         steroid treatment was started because of worsening
    3
    -
    -
         disease progression
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NuSepin 0.1 mg/kg
    Reporting group description
    		 NuSepin powder dissolved and diluted for infusion at 0.1 mg/kg in 100 ml NaCl solution.

    Reporting group title
    NuSepin 0.2 mg/kg
    Reporting group description
    		 NuSepin powder dissolved and diluted for infusion at 0.2 mg/kg in 100 ml NaCl solution.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo infusion of standard 100 ml NaCl solution.

    Reporting group values
    		 NuSepin 0.1 mg/kg NuSepin 0.2 mg/kg Placebo Total
    Number of subjects
    		 22 22 20 64
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 16 15 13 44
        From 65-84 years
    		 6 7 7 20
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62 (58 to 66) 59 (54 to 68) 63 (56 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 12 10 10 32
        Male
    		 10 12 10 32
    Subject analysis sets

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All SAS patients receiving at least one dose of study medication and having at least one post-baseline efficacy measurement

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All ITT patients who had at baseline 6-category ordinal scale ≥3 - used only for the primary efficacy endpoint

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients completing the study without major protocol deviations

    Subject analysis sets values
    		 SAS ITT mITT PP
    Number of subjects
    64
    64
    61
    54
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    44
    44
    42
    37
        From 65-84 years
    20
    20
    19
    17
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    61 (57 to 67)
    61 (57 to 67)
    61 (57 to 67)
    61 (57 to 68)
    Gender categorical
    Units: Subjects
        Female
    32
    32
    30
    26
        Male
    32
    32
    31
    28

    End points

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    End points reporting groups
    Reporting group title
    NuSepin 0.1 mg/kg
    Reporting group description
    		 NuSepin powder dissolved and diluted for infusion at 0.1 mg/kg in 100 ml NaCl solution.

    Reporting group title
    NuSepin 0.2 mg/kg
    Reporting group description
    		 NuSepin powder dissolved and diluted for infusion at 0.2 mg/kg in 100 ml NaCl solution.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo infusion of standard 100 ml NaCl solution.

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All SAS patients receiving at least one dose of study medication and having at least one post-baseline efficacy measurement

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All ITT patients who had at baseline 6-category ordinal scale ≥3 - used only for the primary efficacy endpoint

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients completing the study without major protocol deviations

    Primary: Difference in Time to Clinical Improvement (TTCI) between the 2 treatment and the placebo group

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    End point title
    		 Difference in Time to Clinical Improvement (TTCI) between the 2 treatment and the placebo group [1]
    End point description
    The primary endpoint parameter is time to clinical improvement (censored at Day 29), defined as the time (in days) from randomization of study treatment (NuSepin or placebo) until a decline of two categories on a six-category ordinal scale* of clinical status (1 ꞊ complete clinical remission; 6 ꞊ death) * Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3.Hospitalization, requiring supplemental oxygen (such as LFNC or facial mask); 2. Hospitalization, not requiring supplemental oxygen; 1. Complete clinical remission, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Abbreviations: IMV= invasive mechanical ventilation; NIV=non-invasive mechanical ventilation; HFNC=High-flow nasal cannula; LFNC= Low-flow nasal cannula.
    End point type
    Primary
    End point timeframe
    Up to 29 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Currently, there is an ongoing discussion for business partners about licensing out of this compound. Therefore, the results of endpoints are confidential and it is difficult to post them to open public source. Shaperon would be very much appreciated if EudraCT accepts the late posting. Thank you
    End point values
    		 NuSepin 0.1 mg/kg NuSepin 0.2 mg/kg Placebo ITT mITT PP
    Number of subjects analysed
    22 [2]
    22 [3]
    20 [4]
    64
    61
    54
    Units: Days
    22
    22
    20
    64
    61
    54
    Notes
    [2] - Subjects with NuSepin 0.1 mg/kg treatment
    [3] - Subjects with NuSepin 0.2 mg/kg treatment
    [4] - Subjects with SOC (placebo) treatment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the treatment start day (day1), the follow-up period starts and continues until Day 29, when the last study visit (EoS) will take place. If subjects are discharged within the visit window of EoS visit, they go through EoS procedures.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Group for SOC treatments

    Reporting group title
    NuSepin 0.1 mg/kg
    Reporting group description
    		 Group for SOC with NuSepin 0.1 mg/kg treatment

    Reporting group title
    NuSepin 0.2 mg/kg
    Reporting group description
    		 Group for SOC with NuSepin 0.2 mg/kg treatment

    Serious adverse events
    		 Placebo NuSepin 0.1 mg/kg NuSepin 0.2 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo NuSepin 0.1 mg/kg NuSepin 0.2 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 20 (20.00%)
    6 / 22 (27.27%)
    5 / 22 (22.73%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 22 (9.09%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    2
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    3
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Leukocytosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2021
    Inclusion criteria is added 1) Patients with NEWS2 score > 7 2)In order to be able to reach the primary endpoint, only subjects with clinical status 3 or higher (i.e.worse) should be considered for enrollment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The present study has several limitations because of limited sample size. Large-scale validation 19 study would increase the generalizability of our results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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