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    Clinical Trial Results:
    A Pragmatic Proof of Concept Study to Evaluate the Effect of Benralizumab on Mannitol Challenge in Severe Eosinophilic Asthma

    Summary
    EudraCT number
    		 2019-003763-22
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1.027.19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Dundee - NHS Tayside
    Sponsor organisation address
    Residency block, level 3, Ninewells Hospital, George Pirie Way, Dundee, United Kingdom, DD1 9SY
    Public contact
    Anna Forber, General enquiries Scottish Centre for Respiratory Research 01382 383 902 scrr@dundee.ac.uk, 01382 383902, scrr@dundee.ac.uk
    Scientific contact
    Anna Forber, General enquiries Scottish Centre for Respiratory Research 01382 383 902 scrr@dundee.ac.uk, 01382 383902, scrr@dundee.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
    01 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of benralizumab on airway hyper-responsiveness (AHR), after 3 months of treatment, measured by mannitol challenge as the provocative dose causing a 10% fall in forced expratory volume in 1 second (FEV1) (PD10 Mannitol), from post-run-in baseline in severe eosinophilic asthma.
    Protection of trial subjects
    The provocative dose of mannitol required to drop a subject's FEV1 by 10% (PD10) was chosen as this was a cohort of severe asthma patients and therefore we opted for a safer cut point than other studies that have traditionally used PD15. We monitored patients 1 on 1 for the entirety of the mannitol challenges to minimise distress.
    Background therapy
    		 Subjects were maintained on their usual inhaler and oral therapy for asthma control to ensure safety. This meant that benralizumab was used as an additional medication on top of their usual standard of care.
    Evidence for comparator
    		 There was no comparison in this trial as large Phase III trials have shown good efficacy for benralizumab in the treatment of severe eosinophilic asthma. Our study was a single arm open label trial as we felt it was unethical to give patients placebo when there is established evidence that benralizumab improves clinical outcomes.
    Actual start date of recruitment
    16 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    0
    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)
    13
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 21 severe eosinophilic asthma patients were recruited between 16/12/20 and 15/12/21 from Dundee, Scotland, UK.

    Pre-assignment
    Screening details
    		 Key inclusion criteria included patients aged 18 - 75 with severe GINA defined asthma taking a medium to high dose of ICS/LABA. Patients also had to have uncontrolled asthma (ACQ≥1.5), mannitol PD10 ≤635mg at visit 1 and eosinophilic asthma. There was a 4 week run-in period between screen and visit 1. In total 34 patients were screened.

    Period 1
    Period 1 title
    overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 -
    Arm type
    		 Single arm open label

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30mg every 4 weeks for 3 doses

    Number of subjects in period 1
    		Baseline
    Started
    21
    Completed
    21
    Period 2
    Period 2 title
    none
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 none
    Arm description
    		 -
    Arm type
    		 none

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		none
    Started
    1
    Completed
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Our study was a single arm open label study. However the system does not allow submission of the form unless there are two arms so we have created one with zero values to facilitate form submission.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 21 21
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53 ± 16 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 12 12
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30 ± 5.5 -
    Inhaled corticosteroid beclomethasone diproprionate equivalent dose
    Units: mcg
        arithmetic mean (standard deviation)
    		 1895 ± 273 -
    Peripheral blood eosinophils
    Units: cells/microlitre
        arithmetic mean (standard deviation)
    		 439 ± 316 -
    Asthma control questionnaire (6 point)
    Units: points
        arithmetic mean (standard deviation)
    		 2.6 ± 0.9 -
    mini Asthma Quality of Life Questionnaire
    Units: points
        arithmetic mean (standard deviation)
    		 3.6 ± 1.3 -
    Forced expiratory volume in 1 second
    Units: litre(s)
        arithmetic mean (standard deviation)
    		 2.37 ± 1.00 -
    Forced expiratory flow rate between 25 and 75% of forced vital capacity
    Units: L/s
        arithmetic mean (standard deviation)
    		 1.48 ± 0.90 -
    Fractional exhaled nitric oxide
    Units: ppb
        arithmetic mean (standard deviation)
    		 51 ± 42 -
    Forced vital capacity
    Units: litre(s)
        arithmetic mean (standard deviation)
    		 3.62 ± 1.42 -
    FEV1/FVC ratio
    Units: unit(s)
        arithmetic mean (standard deviation)
    		 65.5 ± 9.4 -
    R5-R20
    Units: kPa/L/s
        arithmetic mean (standard deviation)
    		 0.14 ± 0.12 -
    X5
    Units: kPa/L/s
        arithmetic mean (standard deviation)
    		 -0.28 ± 0.22 -
    AX
    Units: kPa/L
        arithmetic mean (standard deviation)
    		 2.77 ± 2.83 -
    Mannitol PD10
    Units: mg
        log mean (standard deviation)
    		 1.8278 ± 0.66186 -
    R5
    Units: kPa/L/s
        arithmetic mean (standard deviation)
    		 0.53 ± 0.18 -
    R20
    Units: kPa/L/s
        arithmetic mean (standard deviation)
    		 0.39 ± 0.10 -
    Fres
    Units: Hz
        arithmetic mean (standard deviation)
    		 22.32 ± 6.57 -
    Eosinophil derived neurotoxin
    Units: ng/ml
        arithmetic mean (standard deviation)
    		 65.6 ± 26.6 -
    Diary card peak flow
    Units: litre(s)
        arithmetic mean (standard deviation)
    		 357 ± 130 -
    Diary card symptoms
    Units: units
        arithmetic mean (standard deviation)
    		 1.7 ± 0.6 -
    Diary card reliever use
    Units: number of puffs used
        arithmetic mean (standard deviation)
    		 3.4 ± 3.1 -

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -
    Reporting group title
    none
    Reporting group description
    		 -

    Primary: Mannitol PD10

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    End point title
    		 Mannitol PD10
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: milligram(s)
        geometric mean (confidence interval 95%)
    67 (34 to 135)
    0 (0 to 0)
    Statistical analysis title
    		 Geometric mean fold difference at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.01 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Single arm open label
    [2] - Bonferroni corrected

    Secondary: Mannitol RDR

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    End point title
    		 Mannitol RDR
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: geometric mean fold difference
        geometric mean (confidence interval 95%)
    0.2 (0.1 to 0.5)
    0 (0 to 0)
    Statistical analysis title
    		 Geometric mean fold difference in RDR at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.01 [4]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Single arm open label
    [4] - Bonferroni corrected

    Secondary: FEV1

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    End point title
    		 FEV1
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: litre(s)
        arithmetic mean (confidence interval 95%)
    0.12 (-0.15 to 0.39)
    0 (0 to 0)
    Statistical analysis title
    		 Change in FEV1 at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 > 0.05 [6]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - Single arm open label
    [6] - Bonferroni corrected

    Secondary: FEF25-75

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    End point title
    		 FEF25-75
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: litres/second
        arithmetic mean (confidence interval 95%)
    0.05 (-0.27 to 0.37)
    0 (0 to 0)
    Statistical analysis title
    		 Change in FEF25-75 at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 > 0.05 [8]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - Single arm open label
    [8] - Bonferroni corrected

    Secondary: FVC

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    End point title
    		 FVC
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: litres
        arithmetic mean (confidence interval 95%)
    0.16 (-0.05 to 0.37)
    0 (0 to 0)
    Statistical analysis title
    		 Change in FVC at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 > 0.05 [10]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [9] - Single arm open label
    [10] - Bonferroni corrected

    Secondary: FEV1/FVC

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    End point title
    		 FEV1/FVC
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: ratio
        arithmetic mean (confidence interval 95%)
    1.0 (-1.9 to 3.9)
    0 (0 to 0)
    Statistical analysis title
    		 Change in FEV1/FVC at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 > 0.05 [12]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [11] - Single arm open label
    [12] - Bonferroni corrected

    Secondary: R5-R20

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    End point title
    		 R5-R20
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: kPa/L/s
        arithmetic mean (confidence interval 95%)
    0.00 (-0.04 to 0.04)
    0 (0 to 0)
    Statistical analysis title
    		 Change in R5-R20 at 12 weeks
    Comparison groups
    none v Baseline
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 > 0.05 [14]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [13] - Single arm open label
    [14] - Bonferroni corrected

    Secondary: X5

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    End point title
    		 X5
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: kPa/L/s
        arithmetic mean (confidence interval 95%)
    0.04 (-0.04 to 0.12)
    0 (0 to 0)
    Statistical analysis title
    		 Change in X5 at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 > 0.05 [16]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [15] - Single arm open label
    [16] - Bonferroni corrected

    Secondary: AX

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    End point title
    		 AX
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: kPa/L
        arithmetic mean (confidence interval 95%)
    -0.46 (-1.43 to 0.50)
    0 (0 to 0)
    Statistical analysis title
    		 Change in AX at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 > 0.05 [18]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [17] - Single arm open label
    [18] - Bonferroni corrected

    Secondary: Peripheral blood eosinophils

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    End point title
    		 Peripheral blood eosinophils
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: cells/microlitre
        arithmetic mean (confidence interval 95%)
    -426 (-574 to -277)
    0 (0 to 0)
    Statistical analysis title
    		 Change in PBE at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 < 0.0001 [20]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [19] - Single arm open label
    [20] - Bonferroni corrected

    Secondary: Eosinophil derived neurotoxin

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    End point title
    		 Eosinophil derived neurotoxin
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: ng/ml
        arithmetic mean (confidence interval 95%)
    -50.3 (-62.2 to -38.5)
    0 (0 to 0)
    Statistical analysis title
    		 Change in EDN at 12 weeks
    Comparison groups
    none v Baseline
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 < 0.0001 [22]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [21] - Single arm open label
    [22] - Bonferroni corrected

    Secondary: Fractional exhaled nitric oxide

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    End point title
    		 Fractional exhaled nitric oxide
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: Parts per billion
        arithmetic mean (confidence interval 95%)
    8 (-11 to 28)
    0 (0 to 0)
    Statistical analysis title
    		 Change in FeNO at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 > 0.05 [24]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [23] - Single arm open label
    [24] - Bonferroni corrected

    Secondary: Asthma Control Questionnaire 6

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    End point title
    		 Asthma Control Questionnaire 6
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: units
        arithmetic mean (confidence interval 95%)
    -1.5 (-2.0 to -1.1)
    0 (0 to 0)
    Statistical analysis title
    		 Change in ACQ6 at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 < 0.0001 [26]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [25] - Single arm open label
    [26] - Bonferroni corrected

    Secondary: Mini Asthma Quality of Life Questionnaire

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    End point title
    		 Mini Asthma Quality of Life Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: units
        arithmetic mean (confidence interval 95%)
    1.7 (1.1 to 2.3)
    0 (0 to 0)
    Statistical analysis title
    		 Change in mii-AQLQ at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 < 0.0001 [28]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [27] - Single arm open label
    [28] - Bonferroni corrected

    Secondary: Diary card peak expiratory flow

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    End point title
    		 Diary card peak expiratory flow
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: litres/minute
        arithmetic mean (confidence interval 95%)
    48 (21 to 74)
    0 (0 to 0)
    Statistical analysis title
    		 Change in PEF at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 < 0.01 [30]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [29] - Single arm open label
    [30] - Bonferroni corrected

    Secondary: Diary card symptoms

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    End point title
    		 Diary card symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: units
        arithmetic mean (confidence interval 95%)
    -0.7 (-0.9 to -0.5)
    0 (0 to 0)
    Statistical analysis title
    		 Change in diary card symptoms at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 < 0.0001 [32]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [31] - Single arm open label
    [32] - Bonferroni corrected

    Secondary: Diary card reliever use

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    End point title
    		 Diary card reliever use
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Baseline none
    Number of subjects analysed
    21
    1
    Units: units
        arithmetic mean (confidence interval 95%)
    -2 (-3 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 Change in diary card reliever use at 12 weeks
    Comparison groups
    Baseline v none
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    P-value
    		 < 0.05 [34]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [33] - Single arm open label
    [34] - Bonferroni corrected

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study enrolment to last patient last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    BISA
    Reporting group description
    		 -

    Serious adverse events
    		 BISA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Hospitalisation
    Additional description: Coronavirus disease 2019
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BISA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 21 (85.71%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    20
    General disorders and administration site conditions
    Sinusitis
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    7
    Fatigue
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Mechanical fall
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Gastrointestinal disorders
    Heartburn
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Breathlessness
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    12
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    5
    Exacerbation of asthma
         subjects affected / exposed
    5 / 21 (23.81%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    4 / 21 (19.05%)
         occurrences all number
    5
    Allergic rhinitis
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    4
    Infections and infestations
    Coronavirus disease 2019
         subjects affected / exposed
    7 / 21 (33.33%)
         occurrences all number
    7
    Flu-like illness
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jan 2021
    Government mandated lockdown in response to coronavirus disease 2019 pandemic
    13 Apr 2021

    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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