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    Clinical Trial Results:
    ASpirin as a Treatment for ARDS (STAR) trial: a randomised, double-blind, allocation concealed, placebo-controlled phase 2 trial.

    Summary
    EudraCT number
    2014-002564-32
    Trial protocol
    GB  
    Global end of trial date
    04 Jan 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Feb 2020
    First version publication date
    04 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14043DMcA-AS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02326350
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Belfast Health and Social Care Trust
    Sponsor organisation address
    Grosvenor road, Belfast, United Kingdom, BT179RN
    Public contact
    Danny McAuley, Queen's University Belfast, 0044 02890 976385, d.f.mcauley@qub.ac.uk
    Scientific contact
    Danny McAuley, Queen's University Belfast, 0044 02890 976385, d.f.mcauley@qub.ac.uk
    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
    10 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of this study was to test the hypothesis that aspirin was both safe and effective in the treatment of patients with acute respiratory distress syndrome (ARDS) The trial objective was to undertaken a randomised double blind placebo controlled clinical trial to study whether aspirin improves important surrogate markers of clinical outcome and is safe in adult patients with ARDS.
    Protection of trial subjects
    Patients were closely monitored for AEs. A Clinical Trials Monitor monitored study site compliance with study and sponsor SOPs and provided feedback to the Trial Management Group on any actual or potential problems in relation to safeguarding patients safety and wellbeing. The study protocol was published http://www.criticalcarehorizons.com/2018-star-protocol/.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Feb 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
    United Kingdom: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    38
    From 65 to 84 years
    9
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    The study was open to recruitment between Feb 9, 2015, and Nov 23, 2018. A total of 593 patients were screened and 49 were randomised to the study from 5 study sites in Northern Ireland.

    Pre-assignment
    Screening details
    Patients receiving invasive mechanical ventilation, ARDS as defined by the Berlin definition, Onset within 1 week of identified insult, Within the same 24 hour time period: Hypoxic respiratory failure, Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology, No evidence of heart failure or

    Pre-assignment period milestones
    Number of subjects started
    49
    Number of subjects completed
    49

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Identical placebo and central randomisation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Aspirin
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    75mg

    Arm title
    Placebo
    Arm description
    -
    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
    75gm

    Number of subjects in period 1
    Aspirin Placebo
    Started
    24
    25
    Completed
    24
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aspirin
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    Aspirin Placebo Total
    Number of subjects
    24 25 49
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    19 19 38
        From 65-84 years
    5 4 9
        85 years and over
    0 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.4 ± 12.0 56.4 ± 17.7 -
    Gender categorical
    Units: Subjects
        Female
    10 15 25
        Male
    14 10 24
    Vasopressor Requirement
    Units: Subjects
        Yes
    13 16 29
        No
    11 9 20
    Mode of Ventilation
    Units: Subjects
        Controlled ventilation
    7 13 20
        PS
    7 5 12
        Other
    10 7 17
    Aetiology of ARDs- Smoke/Toxin inhalation
    Units: Subjects
        Yes
    1 2 3
        No
    23 23 46
    Aetiology of ARDS - Gastric Content Aspiration
    Units: Subjects
        Yes
    6 6 12
        No
    18 19 37
    Aetiology of ARDS- Near Drowning
    Units: Subjects
        Yes
    0 0 0
        No
    24 25 49
    Aetiology of ARDS- Thoracic trauma
    Units: Subjects
        Yes
    2 2 4
        No
    22 23 45
    Aetiology of ARDS-Sepsis
    Units: Subjects
        Yes
    5 10 15
        No
    19 15 34
    Aetiology of ARDs- Cardiopulmonary bypass
    Units: Subjects
        Yes
    0 0 0
        No
    24 25 49
    Aetiology of ARDS-Pancreatitis
    Units: Subjects
        Yes
    1 0 1
        No
    23 25 48
    Aetiology of ARDS- Non-thoracic trauma
    Units: Subjects
        Yes
    0 1 1
        No
    24 24 48
    Aetiology of ARDS- Other
    Units: Subjects
        Yes
    1 3 4
        No
    23 22 45
    Aetiology of ARDS- Pneumonia
    Units: Subjects
        Yes
    14 13 27
        No
    10 12 22
    Height
    Units: cm
        arithmetic mean (standard deviation)
    169.2 ± 13.3 166.7 ± 11.8 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    78.1 ± 23.9 76.8 ± 24.0 -
    Worst PF Ratio (pre-randomisation)
    Units: kPa
        arithmetic mean (standard deviation)
    13.6 ± 6.4 13.1 ± 6.1 -
    PF Ratio
    This data was collected at baseline
    Units: kPa
        arithmetic mean (standard deviation)
    26.3 ± 7.7 23.8 ± 6.7 -
    Plateau Pressure
    Aspirin, n=12 Placebo, n=15
    Units: cm H2O
        arithmetic mean (standard deviation)
    23.5 ± 6 24.1 ± 4.9 -
    Lowest Platelets
    Units: 10^9 per litre
        arithmetic mean (standard deviation)
    229.5 ± 105.8 168.4 ± 86.5 -
    Tidal Volume per Predicted Body Weight (All patients)
    Units: ml per kg
        arithmetic mean (standard deviation)
    7.2 ± 2.3 7.6 ± 2.4 -
    Tidal Volume per Predicted Body Weight (Controlled ventilation)
    Aspirin, n=7 Placebo, n=13
    Units: ml per kg
        arithmetic mean (standard deviation)
    7.2 ± 2.3 6.7 ± 2.1 -
    SAPS
    Aspirin, n=23 Placebo, n=25
    Units: score
        arithmetic mean (standard deviation)
    48.4 ± 16.8 50.8 ± 15.5 -
    APACHE II
    Units: score
        arithmetic mean (standard deviation)
    24.4 ± 7.3 22.0 ± 7.7 -
    SOFA
    Aspirin, n=23 Placebo, n=24
    Units: score
        arithmetic mean (standard deviation)
    9.4 ± 3.3 10.3 ± 4.0 -
    Oxygenation Index
    Units: cmH2O/kPa
        arithmetic mean (standard deviation)
    59.3 ± 30.3 66.3 ± 21.0 -
    Lowest Mean Arterial Pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    64.3 ± 7.2 65.0 ± 5.3 -

    End points

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    End points reporting groups
    Reporting group title
    Aspirin
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Oxygenation Index - Day 7

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    End point title
    Oxygenation Index - Day 7
    End point description
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    17
    17
    Units: mmHg
        arithmetic mean (standard deviation)
    54.4 ± 26.8
    42.4 ± 25.0
    Statistical analysis title
    Primary outcome: Oxygenation Index (Day 7)
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.19
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.1
         upper limit
    30.1

    Primary: Oxygenation index - Day 7 (Imputed)

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    End point title
    Oxygenation index - Day 7 (Imputed)
    End point description
    End point type
    Primary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: mmHg
        arithmetic mean (standard deviation)
    45.7 ± 27.0
    46.8 ± 33.8
    Statistical analysis title
    Oxygenation Index - Day 7 (Imputed)
    Comparison groups
    Placebo v Aspirin
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.7
         upper limit
    16.6

    Secondary: Oxygenation Index - Day 4

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    End point title
    Oxygenation Index - Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    Aspirin Placebo
    Number of subjects analysed
    22
    23
    Units: mmHg
        arithmetic mean (standard deviation)
    61.4 ± 36.9
    54.5 ± 28.8
    Statistical analysis title
    Oxygenation Index - Day 4
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.49
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    6.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13
         upper limit
    26.8

    Secondary: Oxygenation index - Day 14

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    End point title
    Oxygenation index - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Aspirin Placebo
    Number of subjects analysed
    7
    10
    Units: mmHg
        arithmetic mean (standard deviation)
    52.3 ± 36.6
    37.4 ± 24.1
    Statistical analysis title
    Oxygenation Index - Day 14
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.33
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    14.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.4
         upper limit
    46.1

    Secondary: Respiratory Compliance - Day 4

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    End point title
    Respiratory Compliance - Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    Aspirin Placebo
    Number of subjects analysed
    9
    9
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    31.5 ± 24.3
    24.6 ± 11.8
    Statistical analysis title
    Respiratory Compliance - Day 4
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.46
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    6.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.2
         upper limit
    25.9

    Secondary: Respiratory Compliance - Day 7

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    End point title
    Respiratory Compliance - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    4
    4
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    65.5 ± 81.2
    37.1 ± 25.4
    Statistical analysis title
    Respiratory Compliance - Day 7
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.53
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    28.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -75.7
         upper limit
    132.4

    Secondary: Respiratory Compliance - Day 14

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    End point title
    Respiratory Compliance - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Aspirin Placebo
    Number of subjects analysed
    1
    1
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    36.5 ± 0
    14.2 ± 0
    No statistical analyses for this end point

    Secondary: Delta SOFA - Day 4

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    End point title
    Delta SOFA - Day 4
    End point description
    Change from Day 0 to Day 4
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    Aspirin Placebo
    Number of subjects analysed
    22
    21
    Units: score
        arithmetic mean (standard deviation)
    -1.3 ± 2.9
    -1.9 ± 2.9
    Statistical analysis title
    Delta SOFA - Day 4
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.85
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    2.3

    Secondary: Delta SOFA - Day 7

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    End point title
    Delta SOFA - Day 7
    End point description
    Change from Day 0 to Day 7
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    20
    21
    Units: score
        arithmetic mean (standard deviation)
    -2.8 ± 3.8
    -4.4 ± 3.0
    Statistical analysis title
    Delta SOFA - Day 7
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.13
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    3.8

    Secondary: Delta SOFA - Day 14

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    End point title
    Delta SOFA - Day 14
    End point description
    Change from Day 0 to Day 14
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Aspirin Placebo
    Number of subjects analysed
    10
    13
    Units: score
        arithmetic mean (standard deviation)
    -2.7 ± 3.6
    -7.3 ± 4.0
    Statistical analysis title
    Delta SOFA - Day 14
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.3
         upper limit
    7.9

    Secondary: PF ratio - Day 4

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    End point title
    PF ratio - Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    23
    Units: kpa
        arithmetic mean (standard deviation)
    26.1 ± 9.2
    25.6 ± 9.0
    Statistical analysis title
    PF ratio - Day 4
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.85
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.9
         upper limit
    5.9

    Secondary: PF ratio - Day 7

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    End point title
    PF ratio - Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    21
    22
    Units: kPa
        arithmetic mean (standard deviation)
    26.8 ± 9.9
    30.6 ± 12.2
    Statistical analysis title
    PF ratio - Day 7
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.27
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.6
         upper limit
    3.1

    Secondary: PF ratio - Day 14

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    End point title
    PF ratio - Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Aspirin Placebo
    Number of subjects analysed
    10
    15
    Units: kPa
        arithmetic mean (standard deviation)
    27.7 ± 9.9
    28.8 ± 8.8
    Statistical analysis title
    PF ratio - Day 14
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.76
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9
         upper limit
    6.6

    Secondary: SUSAR

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    End point title
    SUSAR
    End point description
    Safety and tolerability was assessed by the occurrence of suspected unexpected serious adverse reactions (SUSAR).
    End point type
    Secondary
    End point timeframe
    28 day
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: events
    0
    0
    No statistical analyses for this end point

    Secondary: SOFA - Day 4

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    End point title
    SOFA - Day 4
    End point description
    End point type
    Secondary
    End point timeframe
    Day 4
    End point values
    Aspirin Placebo
    Number of subjects analysed
    23
    24
    Units: score
        arithmetic mean (standard deviation)
    8.0 ± 4.01
    8.1 ± 4.17
    Statistical analysis title
    SOFA - Day 4
    Comparison groups
    Placebo v Aspirin
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.88
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.64
         upper limit
    2.28

    Secondary: SOFA - day7

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    End point title
    SOFA - day7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Aspirin Placebo
    Number of subjects analysed
    21
    22
    Units: score
        arithmetic mean (standard deviation)
    6.5 ± 3.84
    6.2 ± 4.24
    Statistical analysis title
    SOFA - Day 7
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.81
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    2.79

    Secondary: SOFA - day14

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    End point title
    SOFA - day14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Aspirin Placebo
    Number of subjects analysed
    10
    13
    Units: score
        arithmetic mean (standard deviation)
    5.5 ± 4.22
    3.8 ± 2.35
    Statistical analysis title
    SOFA - Day 14
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.22
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.14
         upper limit
    4.61

    Other pre-specified: Ventilator Free Day Score

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    End point title
    Ventilator Free Day Score
    End point description
    End point type
    Other pre-specified
    End point timeframe
    28 day
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: score
        median (inter-quartile range (Q1-Q3))
    16 (0 to 21.5)
    15 (0 to 21)
    Statistical analysis title
    VFD Score
    Comparison groups
    Placebo v Aspirin
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.72
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ventilation - All patients

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    End point title
    Duration of ventilation - All patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Duration of ventilation
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: days
        median (inter-quartile range (Q1-Q3))
    10 (5.5 to 15)
    10 (6 to 19)
    Statistical analysis title
    Duration of Ventilation - All patients
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.43
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ventilation - Achieved unassisted breathing

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    End point title
    Duration of ventilation - Achieved unassisted breathing
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Duration of ventilation
    End point values
    Aspirin Placebo
    Number of subjects analysed
    10
    10
    Units: days
        median (inter-quartile range (Q1-Q3))
    8 (5 to 13)
    9.5 (6 to 21)
    Statistical analysis title
    Duration of ventilation - Achieved UB
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.37
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ventilation - Died

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    End point title
    Duration of ventilation - Died
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Duration of ventilation
    End point values
    Aspirin Placebo
    Number of subjects analysed
    3
    5
    Units: days
        median (inter-quartile range (Q1-Q3))
    13 (10 to 20)
    15 (9 to 18)
    Statistical analysis title
    Duration of ventilation - Died
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.88
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ICU stay - All patients

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    End point title
    Duration of ICU stay - All patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    ICU stay
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: days
        median (inter-quartile range (Q1-Q3))
    12.5 (8 to 21.5)
    15 (9 to 18)
    Statistical analysis title
    Duration of ICU stay - All patients
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.51
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ICU stay - Alive at discharge

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    End point title
    Duration of ICU stay - Alive at discharge
    End point description
    End point type
    Other pre-specified
    End point timeframe
    ICU stay
    End point values
    Aspirin Placebo
    Number of subjects analysed
    20
    20
    Units: days
        median (inter-quartile range (Q1-Q3))
    12 (7 to 22)
    14 (8 to 31.5)
    Statistical analysis title
    Duration of ICU stay - Alive at discharge
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.33
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of ICU stay - Died

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    End point title
    Duration of ICU stay - Died
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Study period
    End point values
    Aspirin Placebo
    Number of subjects analysed
    4
    5
    Units: days
        median (inter-quartile range (Q1-Q3))
    16.5 (11.5 to 21.5)
    15 (9 to 18)
    Statistical analysis title
    Duration of ICU stay - Died
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    9
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.62
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of hospital stay - All patients

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    End point title
    Duration of hospital stay - All patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Hospital stay
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: days
        median (inter-quartile range (Q1-Q3))
    20.5 (15 to 29)
    26 (15 to 67)
    Statistical analysis title
    Duration of Hospital Stay - All patients
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.51
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of hospital stay - Alive at discharge

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    End point title
    Duration of hospital stay - Alive at discharge
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Hospital stay
    End point values
    Aspirin Placebo
    Number of subjects analysed
    17
    20
    Units: days
        median (inter-quartile range (Q1-Q3))
    22 (18 to 32)
    29 (17 to 84)
    Statistical analysis title
    Duration of Hospital stay - Alive at discharge
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.31
    Method
    Sign test
    Confidence interval

    Other pre-specified: Duration of hospital stay - Died

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    End point title
    Duration of hospital stay - Died
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Hospital stay
    End point values
    Aspirin Placebo
    Number of subjects analysed
    7
    5
    Units: days
        median (inter-quartile range (Q1-Q3))
    17 (10 to 23)
    15 (9 to 18)
    Statistical analysis title
    Duration of hospital stay - Died
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.68
    Method
    Sign test
    Confidence interval

    Other pre-specified: All cause mortality - 28 day

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    End point title
    All cause mortality - 28 day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    28 days
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: subjects
        Alive
    18
    20
        Dead
    6
    5
    Statistical analysis title
    Mortality rate- 28 days
    Comparison groups
    Aspirin v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.74
    Method
    Fisher exact
    Confidence interval

    Other pre-specified: All cause mortality - 90 day

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    End point title
    All cause mortality - 90 day
    End point description
    End point type
    Other pre-specified
    End point timeframe
    90 days
    End point values
    Aspirin Placebo
    Number of subjects analysed
    24
    25
    Units: subjects
        Alive
    17
    20
        Dead
    7
    5
    Statistical analysis title
    Mortality rate - 90 days
    Comparison groups
    Placebo v Aspirin
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.52
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs that occur between trial entry and up to 28 days after completion of the study drug was reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Aspirin
    Reporting group description
    Treatment arm

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Aspirin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    3 / 25 (12.00%)
         number of deaths (all causes)
    7
    5
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CVA infarct
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Aspirin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 24 (37.50%)
    10 / 25 (40.00%)
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Over-sedation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 24 (25.00%)
    7 / 25 (28.00%)
         occurrences all number
    7
    7
    Thrombocytosis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Anaemia- Requiring transfusion
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Eye disorders
    Bilateral sub-conjunctival Haemorrhage
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2016
    The exclusion criteria to allow recruitment of patients with a platelet count less than 100 x109/l was adjusted to less than 50 x109/ l.
    09 Aug 2016
    Extension of study form single site study to multi centre study.
    23 Aug 2017
    The exclusion of those with active or recurrent peptic ulcer disease was limited to active disease within the last 5 years.

    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 DMC decided to stop the study prior to reaching the target population on the basis of slow recruitment. No safety concerns were highlighted by the DMC. An SAE was identified post consent in a patient. Patient was not randomised to the study
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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