Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Senicapoc in COVID-19 Patients with Severe Respiratory Insufficiency – A Randomized, Open-Label, Phase II Trial

    Summary
    EudraCT number
    		 2020-001420-34
    Trial protocol
    		 DK  
    Global end of trial date
    28 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2022
    First version publication date
    21 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04594668
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Ole Worms Allé 4, Building 1160, Aarhus C, Denmark, 8000
    Public contact
    www.Clinicaltrials.gov, Aarhus University, +45 60202613, us@biomed.au.dk
    Scientific contact
    www.Clinicaltrials.gov, Aarhus University, +45 60202613, us@biomed.au.dk
    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
    30 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To treat respiratory insufficiency due to COVID19
    Protection of trial subjects
    The study was IDMC monitored. Patients were admitted to the ICU and the intervention did not include additional stress or pain
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    21
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients were included if they were aged ≥ 18 years and admitted to an ICU with severe respiratory insufficiency due to COVID-19. COVID-19 was defined as a positive polymerase chain reaction (PCR) test for SARS-CoV-2, within 14 days prior to ICU admission. Severe respiratory insufficiency was defined as requiring supplemental oxygen ≥ 10 L/min or m

    Period 1
    Period 1 title
    Entire study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 Control group
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Senicapoc group
    Arm description
    		 Senicapoc group
    Arm type
    		 Experimental

    Investigational medicinal product name
    Senicapoc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Intragastric use
    Dosage and administration details
    The intervention consisted of 50 mg enteral senicapoc (5 x 10 mg tablets) administered as soon as possible after randomization and again after 24 hours.

    Number of subjects in period 1
    		Control group Senicapoc group
    Started
    26
    20
    Completed
    26
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Control group

    Reporting group title
    Senicapoc group
    Reporting group description
    		 Senicapoc group

    Reporting group values
    		 Control group Senicapoc group Total
    Number of subjects
    		 26 20 46
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66 (56 to 74) 66 (58 to 70) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 6 10 16
        Male
    		 20 10 30

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 Control group

    Reporting group title
    Senicapoc group
    Reporting group description
    		 Senicapoc group

    Primary: The PaO2/FiO2 ratio

    		 Close Top of page
    End point title
    		 The PaO2/FiO2 ratio
    End point description
    The PaO2/FiO2 ratio at 72 hours
    End point type
    Primary
    End point timeframe
    at 72 hours
    End point values
    		 Control group Senicapoc group
    Number of subjects analysed
    26
    20
    Units: mmHg
        arithmetic mean (standard deviation)
    24.4 ± 9.6
    19.5 ± 6.6
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Control group v Senicapoc group
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2
         upper limit
    		 0.04
    Notes
    [1] - linear regression adjusting for the two stratification variables (baseline PaO2/FiO2 ratio and site) as fixed effects

    Secondary: Mortality

    		 Close Top of page
    End point title
    		 Mortality
    End point description
    Mortality
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Control group Senicapoc group
    Number of subjects analysed
    26
    20
    Units: %
    6
    2
    No statistical analyses for this end point

    Secondary: Ventilator free hours

    		 Close Top of page
    End point title
    		 Ventilator free hours
    End point description
    End point type
    Secondary
    End point timeframe
    ventilator-free days within 28 days
    End point values
    		 Control group Senicapoc group
    Number of subjects analysed
    26
    20
    Units: day
        median (inter-quartile range (Q1-Q3))
    486 (0 to 672)
    607 (398 to 672)
    Statistical analysis title
    		 Ventilator free hours
    Comparison groups
    Senicapoc group v Control group
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Sutdy period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Specific adverse
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 -

    Reporting group title
    Senicapoc
    Reporting group description
    		 -

    Serious adverse events
    		 Control group Senicapoc
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 26 (84.62%)
    10 / 20 (50.00%)
         number of deaths (all causes)
    6
    2
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    arrythmias
         subjects affected / exposed
    6 / 26 (23.08%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    4 / 26 (15.38%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperglycaemia
         subjects affected / exposed
    7 / 26 (26.92%)
    5 / 20 (25.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control group Senicapoc
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 20 (5.00%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 26 (11.54%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
    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.

    European Medicines Agency © 1995-Mon Apr 29 10:34:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA