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    Clinical Trial Results:
    A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

    Summary
    EudraCT number
    2015-002287-16
    Trial protocol
    BE   GB   AT   NL  
    Global end of trial date
    27 Sep 2017

    Results information
    Results version number
    v3(current)
    This version publication date
    18 May 2019
    First version publication date
    04 Oct 2018
    Other versions
    v1 , v2
    Version creation reason
    • Correction of full data set
    Adding text to “Limitations and Caveats” section

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-218-1797
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02534350
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    27 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Dec 2015
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    United States: 38
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Canada: 1
    Worldwide total number of subjects
    61
    EEA total number of subjects
    19
    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)
    41
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at sites in Europe, North America and Australia.The first participant was screened on 31 December 2015 and the last study visit occurred on 27 September 2017.

    Pre-assignment
    Screening details
    111 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Presatovir
    Arm description
    Administered orally or via nasogastric (NG) tube once daily for 14 days
    Arm type
    Experimental

    Investigational medicinal product name
    Presatovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Nasogastric use , Oral use
    Dosage and administration details
    200 mg (4 x 50 mg) on Day1/Baseline followed by 100 mg (2 x 50 mg) on Days 2 through 14

    Arm title
    Placebo
    Arm description
    Tablets administered orally or via NG tube once daily for 14 days
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Nasogastric use , Oral use
    Dosage and administration details
    Administered orally or via NG tube once daily for 14 days

    Number of subjects in period 1 [1]
    Presatovir Placebo
    Started
    40
    20
    Completed
    37
    20
    Not completed
    3
    0
         Withdrew Consent
    2
    -
         Protocol deviation
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was randomized but not treated was not included.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Presatovir
    Reporting group description
    Administered orally or via nasogastric (NG) tube once daily for 14 days

    Reporting group title
    Placebo
    Reporting group description
    Tablets administered orally or via NG tube once daily for 14 days

    Reporting group values
    Presatovir Placebo Total
    Number of subjects
    40 20 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.4 ± 12.54 55.1 ± 14.23 -
    Gender categorical
    Units: Subjects
        Female
    19 10 29
        Male
    21 10 31
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2 1 3
        Not Hispanic or Latino
    36 19 55
        Unknown or Not Reported
    2 0 2
    Race
    Units: Subjects
        Asian
    0 1 1
        Black or African American
    0 2 2
        Native Hawaiian or Pacific Islander
    1 0 1
        White
    36 16 52
        Other
    1 1 2
        Not Permitted
    2 0 2
    Nasal Viral Load
    Measure Analysis Population Description: Participants in the Safety Analysis Set with available data were analyzed (Presatovir: N = 37; Placebo: N = 20).
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    5.88 ± 2.088 6.59 ± 2.092 -
    inFLUenza Patient- Reported Outcome (FLU-PRO) Score
    Participants in the Safety Analysis Set with available data were analyzed (Presatovir: N = 37; Placebo: N = 18). Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale.
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.05 ± 0.607 2.11 ± 0.684 -
    The Forced Expiratory Volume in One Second (FEV1) % Predicted
    Measure Analysis Population Description: Participants in the Safety Analysis Set with available data were analyzed (Presatovir: N = 40; Placebo: N = 19).
    Units: percent FEV1
        arithmetic mean (standard deviation)
    63.64 ± 24.787 61.95 ± 18.625 -

    End points

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    End points reporting groups
    Reporting group title
    Presatovir
    Reporting group description
    Administered orally or via nasogastric (NG) tube once daily for 14 days

    Reporting group title
    Placebo
    Reporting group description
    Tablets administered orally or via NG tube once daily for 14 days

    Primary: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

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    End point title
    Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set
    End point description
    Participants in the Full Analysis Set (participants who received at least 1 full dose of study drug and had an RSV viral load ≥ lower limit of quantification (LLOQ) of the real-time quantitative polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab) with available data were analyzed .
    End point type
    Primary
    End point timeframe
    Up to 7 days
    End point values
    Presatovir Placebo
    Number of subjects analysed
    35
    19
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -0.73 ± 0.938
    -0.90 ± 0.815
    Statistical analysis title
    Presatovir vs. Placebo
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.72
    Method
    ANCOVA
    Parameter type
    Treatment Difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    0.63

    Primary: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

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    End point title
    Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 7 days
    End point values
    Presatovir Placebo
    Number of subjects analysed
    16
    11
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -0.83 ± 1.013
    -0.83 ± 0.757
    Statistical analysis title
    Presatovir vs. Placebo
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.76
    Method
    ANCOVA
    Parameter type
    Treatment Difference
    Point estimate
    -0.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.94
         upper limit
    0.69

    Secondary: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7

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    End point title
    Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7
    End point description
    The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 7 days
    End point values
    Presatovir Placebo
    Number of subjects analysed
    33
    17
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.27 ± 0.313
    -0.31 ± 0.298
    Statistical analysis title
    Presatovir vs. Placebo
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.86
    Method
    ANCOVA
    Parameter type
    Treatment Difference
    Point estimate
    0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.15

    Secondary: Percent Change From Study Baseline in FEV1% Predicted Value

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    End point title
    Percent Change From Study Baseline in FEV1% Predicted Value
    End point description
    FEV1 is defined as forced expiratory volume in the first second. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Day 28
    End point values
    Presatovir Placebo
    Number of subjects analysed
    30
    17
    Units: percent change
        arithmetic mean (standard deviation)
    22.69 ± 27.437
    26.36 ± 23.312
    Statistical analysis title
    Presatovir vs. Placebo
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6
    Method
    ANCOVA
    Parameter type
    Treatment Difference
    Point estimate
    -3.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.58
         upper limit
    9.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 28
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Tablets administered orally or via NG tube once daily for 14 days

    Reporting group title
    Presatovir
    Reporting group description
    Administered orally or via nasogastric (NG) tube once daily for 14 days

    Serious adverse events
    Placebo Presatovir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 40 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Presatovir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 20 (85.00%)
    24 / 40 (60.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 40 (10.00%)
         occurrences all number
    3
    4
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 40 (10.00%)
         occurrences all number
    0
    4
    Productive cough
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Agitation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Forced expiratory volume decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Blood bicarbonate decreased
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Forced expiratory flow decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 20 (25.00%)
    4 / 40 (10.00%)
         occurrences all number
    6
    4
    Headache
         subjects affected / exposed
    4 / 20 (20.00%)
    5 / 40 (12.50%)
         occurrences all number
    4
    5
    Tremor
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Leukopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    4
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 20 (15.00%)
    5 / 40 (12.50%)
         occurrences all number
    4
    5
    Diarrhoea
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 40 (7.50%)
         occurrences all number
    4
    4
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Glossodynia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Pneumatosis intestinalis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Chronic kidney disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Flank pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Candida infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nasal herpes
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Decreased appetite
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Increased appetite
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    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 Dec 2015
    • Added electrocardiograms (ECGs), troponin testing, and collection of standard of care clinical data for central review • Additional spirometry measurements collected via handheld devices Study Endpoint and statistical analysis revisions • Inclusion criteria updated to allow subjects ≥ 18 to enroll and to allow PCR positive subjects to be enrolled using an upper or lower respiratory tract sample • Exclusion criteria updated to state that viral co-infection and systemic infection may be allowed if discussed with the medical monitor and deemed acceptable; additional restrictions added as related to sulfa drug response • iADL, ADL, and SF-12 assessments for the Optional Registry will begin at Day 1/Baseline • Edits throughout for clarity and administrative changes were made
    12 Sep 2016
    • Renumbering as appropriate due to the addition of new sections • Addition of a window for Day 1/Baseline spirometry and the addition of information and clarification on historical spirometry data that should be collected • Updates to pregnancy testing and requirements • Updates to the Study Design schema to include the spirometry window and PK lab draws • Removal of the requirement for safety labs to be collected during the optional registry • Clarification that only procedure-related AEs need to be collected during the optional Extended Viral Monitoring and Optional Registry portions of the study • Clarification that the Day 21 local RSV PCR testing, as required for the optional extended viral monitoring, does not need to be redone if completed for clinical purposes prior to Day 21 with a negative result •Addition of new Phase 1 data •Consolidation of the Prior and Concomitant Medication section

    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.
    An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.
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