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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

    Summary
    EudraCT number
    		 2017-002156-84
    Trial protocol
    		 SE   LV   LT   FR   DE   SK   BE   CZ   NL   ES   HU   BG   PL   GB   AT   IT   Outside EU/EEA  
    Global end of trial date
    26 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2021
    First version publication date
    13 Mar 2021
    Other versions
    Summary report(s)
    		 63623872FLZ3001 (2017-002156-84)_Limited Results

    Trial information

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    Trial identification
    Sponsor protocol code
    63623872FLZ3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03376321
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001975-PIP01-16
    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
    26 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate superiority of pimodivir in combination with standard-of-care (SOC) treatment compared to placebo in combination with SOC treatment on Day 6, with respect to the clinical outcome on the hospital recovery scale.
    Protection of trial subjects
    Safety assessments included AE, laboratory parameters, electrocardiogram [ECG], vital signs, and National Early Warning Score [NEWS2]).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2017
    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
    Canada: 1
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Austria: 18
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 10
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Latvia: 3
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Israel: 36
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Vietnam: 1
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Malaysia: 21
    Country: Number of subjects enrolled
    India: 18
    Country: Number of subjects enrolled
    Ukraine: 14
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    South Africa: 17
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Thailand: 22
    Worldwide total number of subjects
    326
    EEA total number of subjects
    119
    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)
    4
    Adults (18-64 years)
    192
    From 65 to 84 years
    130
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Overall, 334 subjects were randomized, of which 326 (97.6%) subjects were treated (and included in the Safety Set).

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pimodivir + SOC
    Arm description
    		 Subjects received pimodivir 600 milligram (mg) orally twice daily for 5 days (on Days 1 through 5; for subjects who received only 1 dose of pimodivir on Day 1 [evening], dosing continued until the morning of Day 6) along with SOC treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pimodivir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pimodivir was administered.

    Arm title
    		 Placebo + SOC
    Arm description
    		 Subjects received placebo matching to pimodivir orally twice daily for 5 days (on Days 1 through 5; for subjects who received only 1 dose of placebo on Day 1 [evening], dosing continued until morning of Day 6) along with SOC treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered.

    Number of subjects in period 1
    		Pimodivir + SOC Placebo + SOC
    Started
    163
    163
    Completed
    145
    141
    Not completed
    18
    22
         Adverse event, serious fatal
    4
    -
         Consent withdrawn by subject
    8
    14
         Other
    5
    1
         Lost to follow-up
    1
    7

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Pimodivir + SOC
    Reporting group description
    		 Subjects received pimodivir 600 milligram (mg) orally twice daily for 5 days (on Days 1 through 5; for subjects who received only 1 dose of pimodivir on Day 1 [evening], dosing continued until the morning of Day 6) along with SOC treatment.

    Reporting group title
    Placebo + SOC
    Reporting group description
    		 Subjects received placebo matching to pimodivir orally twice daily for 5 days (on Days 1 through 5; for subjects who received only 1 dose of placebo on Day 1 [evening], dosing continued until morning of Day 6) along with SOC treatment.

    Primary: Hospital Recovery Scale on Day 6

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    End point title
    		 Hospital Recovery Scale on Day 6
    End point description
    The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen (SO); 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation (IMV); 5) requiring invasive mechanical ventilation; and 6) death.
    End point type
    Primary
    End point timeframe
    Day 6
    End point values
    		 Pimodivir + SOC Placebo + SOC
    Number of subjects analysed
    159
    159
    Units: subjects
        Not hospitalized
    73
    69
        Non-ICU hospitalization, not requiring SO
    50
    42
        Non-ICU hospitalization, requiring SO
    18
    25
        Admitted to the ICU, not requiring IMV
    6
    6
        Requiring invasive mechanical ventilation
    2
    3
        Death
    3
    0
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo + SOC v Pimodivir + SOC
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.366
    Method
    		 Van Elteren test
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 33 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Pimodivir + SOC
    Reporting group description
    		 -

    Reporting group title
    Placebo+SOC
    Reporting group description
    		 -

    Serious adverse events
    		 Pimodivir + SOC Placebo+SOC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pimodivir + SOC Placebo+SOC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2018
    The overall reason was to implement the recommendations from specific Health Authorities.

    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 limited results for this early terminated trial are available in the attached CSR synopsis.
    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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