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    Clinical Trial Results:
    A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model

    Summary
    EudraCT number
    		 2015-004296-77
    Trial protocol
    		 GB  
    Global end of trial date
    08 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2018
    First version publication date
    23 Sep 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BTA585-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02718937
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biota Pharma Europe Limited
    Sponsor organisation address
    2500 Northwinds Parkway, Suite 100, Alpharetta, United States, 30009
    Public contact
    Regulatory Affairs, hVIVO Services Limited, +44 02079891313 , regsubmissions@hvivo.com
    Scientific contact
    Regulatory Affairs, hVIVO Services Limited, +44 02079891313 , regsubmissions@hvivo.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
    08 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the antiviral effect of oral BTA-C585 compared to placebo after inoculation with RSV-A Memphis 37b virus.
    Protection of trial subjects
    The study was performed in accordance with applicable regulatory and ethical guidelines including the Declaration of Helsinki and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), and any applicable national and local laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Mar 2016
    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
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a single-center study conducted in the United Kingdom (UK). An additional affiliated site was used for screening and subject recruitment only, which also located in the UK. The study period was March 23, 2016 to December 8, 2016.

    Pre-assignment
    Screening details
    		 Subjects completed a Screening visit within 90 days prior to admission to the quarantine unit. Depending on the length of the Screening period, the duration of a subject's participation from the screening visit to the last scheduled follow-up visit could have been between approximately 1 to 4 months.

    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
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 400 mg BID BTA585
    Arm description
    		 400 mg dose consists of 4x 100 mg capsules of BTA585
    Arm type
    		 Experimental

    Investigational medicinal product name
    BTA-C585
    Investigational medicinal product code
    DV0026664AA
    Other name
    BC73987, BC00073987, PM303103602
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg BTA585 administered via oral route

    Arm title
    		 600 mg BID BTA585
    Arm description
    		 600 mg dose consists of 6x 100 mg capsules of BTA585
    Arm type
    		 Experimental

    Investigational medicinal product name
    BTA-C585
    Investigational medicinal product code
    DV0026664AA
    Other name
    BC73987, BC00073987, PM303103602
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg BTA585 administered via oral route

    Arm title
    		 Placebo
    Arm description
    		 Placebo dose consists of applicable matching placebo capsules.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo capsules administered by oral route.

    Number of subjects in period 1
    		400 mg BID BTA585 600 mg BID BTA585 Placebo
    Started
    20
    20
    20
    Completed
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    400 mg BID BTA585
    Reporting group description
    		 400 mg dose consists of 4x 100 mg capsules of BTA585

    Reporting group title
    600 mg BID BTA585
    Reporting group description
    		 600 mg dose consists of 6x 100 mg capsules of BTA585

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo dose consists of applicable matching placebo capsules.

    Reporting group values
    		 400 mg BID BTA585 600 mg BID BTA585 Placebo Total
    Number of subjects
    		 20 20 20 60
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        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)
    		 20 20 20 60
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.8 ± 8.23 26.5 ± 6.79 25.1 ± 5.13 -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 3 20
        Male
    		 12 11 17 40
    Subject analysis sets

    Subject analysis set title
    400 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Subject analysis set title
    600 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Subject analysis sets values
    		 400 mg 600 mg Placebo
    Number of subjects
    13
    12
    13
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    13
    12
    13
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    400 mg BID BTA585
    Reporting group description
    		 400 mg dose consists of 4x 100 mg capsules of BTA585

    Reporting group title
    600 mg BID BTA585
    Reporting group description
    		 600 mg dose consists of 6x 100 mg capsules of BTA585

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo dose consists of applicable matching placebo capsules.

    Subject analysis set title
    400 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Subject analysis set title
    600 mg
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all randomized subjects who received at least one dose of study drug and Challenge Virus, and provided a positive PCR per the qicPCR prior to randomization, and had at least one quantifiable viral load during quarantine

    Primary: Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay

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    End point title
    		 Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay
    End point description
    The primary efficacy endpoint was the AUC of RSV-A Memphis 37b viral load as determined by RT-qPCR assay of nasal wash from the first viral load measurement post initial study drug dosing through Study Day 12
    End point type
    Primary
    End point timeframe
    First viral load measurement post initial study drug dosing through Study Day 12
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: log10 copies/mL*hours
        arithmetic mean (standard deviation)
    502.72 ± 223.91
    519.81 ± 291.89
    548.65 ± 303.88
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.523 [1]
    Method
    		 ANCOVA
    Confidence interval
         sides
    2-sided
         lower limit
    		 332.266
         upper limit
    		 636.876
    Notes
    [1] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.868 [2]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 376.931
         upper limit
    		 692.845
    Notes
    [2] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.641
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 400.885
         upper limit
    		 618.573

    Primary: Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay Using PFUe

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    End point title
    		 Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay Using PFUe
    End point description
    End point type
    Primary
    End point timeframe
    First dose of study drug through Study Day 12
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: llog10 PFUe/mL*hours)
        arithmetic mean (standard deviation)
    -335.4597 ± 241.32252
    -310.1802 ± 279.45651
    -259.2520 ± 284.02210
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.349 [3]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -501.9907
         upper limit
    		 -204.5268
    Variability estimate
    Standard deviation
    Notes
    [3] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.703 [4]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -449.6412
         upper limit
    		 -141.138
    Variability estimate
    Standard deviation
    Notes
    [4] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.444
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -430.615
         upper limit
    		 -218.0333
    Variability estimate
    Standard deviation

    Primary: Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay (log10 copies)

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    End point title
    		 Area Under Curve of RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay (log10 copies)
    End point description
    End point type
    Primary
    End point timeframe
    First dose of study drug through Study Day 12
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: log10 copies/mL*hours
        arithmetic mean (standard deviation)
    740.6381 ± 151.52373
    745.9596 ± 189.34238
    756.4048 ± 213.34022
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.679 [5]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 627.22
         upper limit
    		 830.262
    Notes
    [5] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    Placebo v 600 mg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.986 [6]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 651.429
         upper limit
    		 862.442
    Notes
    [6] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.804
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 500.7
         upper limit
    		 1137.709
    Variability estimate
    Standard deviation

    Secondary: Area Under Curve of RSV-A Memphis 37b viral load as Determined by Plaque Assay

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    End point title
    		 Area Under Curve of RSV-A Memphis 37b viral load as Determined by Plaque Assay
    End point description
    End point type
    Secondary
    End point timeframe
    First dose of study drug through Study Day 12
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    11
    12
    Units: log10PFU/mL*hours
        arithmetic mean (standard deviation)
    177.2841 ± 175.96635
    231.9255 ± 193.64278
    181.4222 ± 132.33089
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281 [7]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0908
         upper limit
    		 300.6546
    Variability estimate
    Standard deviation
    Notes
    [7] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model.
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.927 [8]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 114.413
         upper limit
    		 488.5367
    Variability estimate
    Standard deviation
    Notes
    [8] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the ANCOVA model.
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 106.3109
         upper limit
    		 345.5367
    Variability estimate
    Standard deviation

    Secondary: Peak RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay

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    End point title
    		 Peak RSV-A Memphis 37b viral load as Determined by RT-qPCR Assay
    End point description
    End point type
    Secondary
    End point timeframe
    Peak viral load from first dose of study drug was the maximum viral load occurring after the initiation of study drug.
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: log10 copies/mL*hours
        arithmetic mean (standard deviation)
    5.7480 ± 1.03010
    5.5098 ± 1.17046
    6.2440 ± 1.52718
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.218 [9]
    Method
    		 ANCOVA
    Confidence interval
         sides
    2-sided
         lower limit
    		 4.9641
         upper limit
    		 6.354
    Variability estimate
    Standard deviation
    Notes
    [9] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the model stated above
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.173 [10]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.863
         upper limit
    		 6.3045
    Variability estimate
    Standard deviation
    Notes
    [10] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the model stated above
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.133
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1247
         upper limit
    		 6.1181
    Variability estimate
    Standard deviation

    Secondary: Peak Viral Load of RSV-A Memphis 37b as Determined by Plaque Assay

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    End point title
    		 Peak Viral Load of RSV-A Memphis 37b as Determined by Plaque Assay
    End point description
    End point type
    Secondary
    End point timeframe
    Peak viral load from the first dose of study drug is the maximum viral load occurring after the initiation of study drug
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: PFUe/mL
        arithmetic mean (standard deviation)
    3.1992 ± 2.10030
    3.5592 ± 1.88389
    3.4792 ± 1.92937
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    Placebo v 400 mg
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05 [11]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2757
         upper limit
    		 3.9832
    Variability estimate
    Standard deviation
    Notes
    [11] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the model stated above.
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.464 [12]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8536
         upper limit
    		 6.2237
    Variability estimate
    Standard deviation
    Notes
    [12] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the model stated above.
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.134 [13]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5066
         upper limit
    		 4.6615
    Variability estimate
    Standard deviation
    Notes
    [13] - The p-value corresponds to pairwise comparisons of each active group versus placebo created from linear contrasts of the model stated above.

    Secondary: Time to Cessation of Viral Shedding by RT-qPCR Assay

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    End point title
    		 Time to Cessation of Viral Shedding by RT-qPCR Assay
    End point description
    End point type
    Secondary
    End point timeframe
    Time to Cessation of Viral Shedding from First Dose of Study Drug
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    11
    12
    Units: hours
        arithmetic mean (standard error)
    148.95 ± 9.388
    155.37 ± 10.113
    168.26 ± 13.401
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 130.97
         upper limit
    		 179.33
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Statistical analysis description
    Cessation of Viral Shedding was considered to occur at the time point where RT-qPCR was negative for RSV and remained negative for all subsequent values. Subjects who did not experience viral shedding were excluded from analysis. Subjects who did not experience cessation of viral shedding were censored at their last non-missing assessment for a given test.
    Comparison groups
    Placebo v 600 mg
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 119.35
         upper limit
    		 179.42
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.151
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 125.91
         upper limit
    		 179.38
    Variability estimate
    Standard error of the mean

    Secondary: Duration of Viral Shedding by RT-qPCR Assay

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    End point title
    		 Duration of Viral Shedding by RT-qPCR Assay
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of viral shedding was calculated as the difference in the date/time of the Cessation of viral shedding and the Initiation of viral shedding.
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    11
    12
    Units: hours
        arithmetic mean (standard deviation)
    143.04 ± 13.729
    146.24 ± 14.245
    155.55 ± 19.212
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.427
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 108
         upper limit
    		 168.07
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.363
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 131.93
         upper limit
    		 168.3
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.309
    Method
    		 Logrank
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 119.97
         upper limit
    		 168.18
    Variability estimate
    Standard deviation

    Secondary: Total Mucus Weight

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    End point title
    		 Total Mucus Weight
    End point description
    End point type
    Secondary
    End point timeframe
    First dose of study drug included all data from the measurement captured following the initiation of study drug through the last measurement captured on Study Day 12 or prior to the last dose of study drug
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: gram(s)
        arithmetic mean (standard deviation)
    12.254 ± 12.0591
    17.208 ± 18.6472
    18.962 ± 29.4035
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.737
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.575
         upper limit
    		 21.392
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.727
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.518
         upper limit
    		 31.362
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.991
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.514
         upper limit
    		 22.834
    Variability estimate
    Standard deviation

    Secondary: AUC of Mucus Weight

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    End point title
    		 AUC of Mucus Weight
    End point description
    End point type
    Secondary
    End point timeframe
    First dose of study drug included all data from the measurement captured following the initiation of study drug through the last measurement captured on Study Day 12 or prior to the last dose of study drug (as appropriate).
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: hours*grams
        arithmetic mean (standard deviation)
    262.789 ± 263.4170
    390.751 ± 425.8803
    427.597 ± 660.8602
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.657
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -47.565
         upper limit
    		 474.304
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.769
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 166.865
         upper limit
    		 708.674
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.933
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 140.159
         upper limit
    		 510.98
    Variability estimate
    Standard deviation

    Secondary: AUC of Subset Symptom Scores

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    End point title
    		 AUC of Subset Symptom Scores
    End point description
    End point type
    Secondary
    End point timeframe
    First Dose of Study Drug through Study Day 12
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: hours*score
        arithmetic mean (standard deviation)
    152.03 ± 179.332
    277.56 ± 253.733
    212.28 ± 222.900
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.407
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.33
         upper limit
    		 303.28
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.888
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 95.81
         upper limit
    		 384.83
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.696
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 104.4
         upper limit
    		 302.23

    Secondary: Time to Peak Subset Symptom Scores

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    End point title
    		 Time to Peak Subset Symptom Scores
    End point description
    End point type
    Secondary
    End point timeframe
    first dose of study drug was the maximum subset symptom score occurring after the initiation of study drug
    End point values
    		 400 mg 600 mg Placebo
    Number of subjects analysed
    13
    12
    13
    Units: hours
        arithmetic mean (standard deviation)
    83.20 ± 80.449
    73.46 ± 47.733
    126.22 ± 79.416
    Statistical analysis title
    		 Statistical Analysis - 400 vs Placebo
    Comparison groups
    400 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.08
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.15
         upper limit
    		 117.75
    Statistical analysis title
    		 Statistical Analysis - 600 vs Placebo
    Comparison groups
    600 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.237
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.05
         upper limit
    		 121.82
    Statistical analysis title
    		 Statistical Analysis - Combined
    Comparison groups
    400 mg v 600 mg v Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.64
         upper limit
    		 108.24

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time of signed informed consent through Study Day 28 or the last study follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    400 mg
    Reporting group description
    		 -

    Reporting group title
    600 mg
    Reporting group description
    		 -

    Reporting group title
    Combined
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 400 mg 600 mg Combined Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Troponin I increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 400 mg 600 mg Combined Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    12 / 20 (60.00%)
    24 / 40 (60.00%)
    12 / 20 (60.00%)
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    0
    3
    Application site discolouration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    3 / 20 (15.00%)
    7 / 20 (35.00%)
    10 / 40 (25.00%)
    3 / 20 (15.00%)
         occurrences all number
    3
    7
    10
    3
    Oropharyngeal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    3 / 20 (15.00%)
         occurrences all number
    1
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Troponin T increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 40 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    1
    2
    3
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    2 / 40 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Dysgeusia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Sinus headache
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
    4 / 40 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    3
    1
    4
    3
    Abdominal discomfort
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
    4 / 40 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    1
    4
    0
    Food poisoning
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Lip ulceration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oral mucosal erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    5 / 20 (25.00%)
    6 / 20 (30.00%)
    11 / 40 (27.50%)
    0 / 20 (0.00%)
         occurrences all number
    5
    6
    11
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    1
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    4 / 40 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    3
    4
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2016
    The amendment incorporated the data available to date from BTA585-001 and BTA585-002. Following the availability of this new data, the starting dose for Cohort 1 was determined and the dose for Cohort 2 identified. Urinalysis testing was removed at certain time points to reduce the risk of unblinding due to BTA585-related chromaturia
    12 May 2016
    Removed NPS Tolerance Test at the Screening visit; clarified the eligibility review process; clarified subject numbering; clarified pre-dose ECG time window; updated new Sponsor name (Aviragen Therapeutics Inc.); added additional cardiac enzymes at the Study Day 28 and follow-up visit to ensure adequate safety assessments took place
    17 Jun 2016
    The amendment included a notice of additional safety measures to be conducted in the study and to request agreement to lift the temporary halt of enrollment into Cohort 1. These safety measures included adding laboratory assessments (hematology, biochemistry, cardiac enzymes, coagulation parameters, and thyroid function) to additional visits and adding additional study stopping criteria based on Troponin I. The risk section was updated in regard to an SAE of increased Troponin I that occurred in Cohort 1. There were also administrative changes associated with the name change from Biota to Aviragen.
    25 Nov 2016
    The amendment notified the change in Principal Investigator from Dr. Samuel Israel to Dr. Andrea Guerra. Additional clarification was added to Study Stopping Criteria based on the MHRA substantial amendment approval letter, dated June 26, 2016.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Jun 2016
    Based on safety concerns, specifically from an SAE that occurred in a subject receiving BTA585 400 mg, the study was placed on temporary halt voluntarily by Aviragen with the agreement of the MHRA on June 6, 2016.
    08 Jul 2016

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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