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    Clinical Trial Results:
    Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in patients suffering from Acute Respiratory Distress Syndrome (ARDS): a double-blind, randomized, placebo-controlled, multicenter Phase 2a/b clinical trial

    Summary
    EudraCT number
    		 2019-001078-27
    Trial protocol
    		 DE   CZ   AT   IT   GR   NL   BE   DK   IE   FI   HU   SK  
    Global end of trial date
    18 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2024
    First version publication date
    19 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1097761/19999
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04417036
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ​Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, ​Leverkusen, Germany, D-51368
    Public contact
    ​Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, ​Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.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
    18 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate safety and efficacy of inhaled PEG-ADM in ARDS
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2020
    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
    Czechia: 10
    Country: Number of subjects enrolled
    Austria: 16
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    90
    EEA total number of subjects
    86
    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)
    54
    From 65 to 84 years
    35
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study Part A was conducted at multiple sites in 7 countries between 07 JUL 2020 (first subject first visit) and 28 DEC 2022 (last subject last visit).

    Pre-assignment
    Screening details
    		 In total, 98 subjects were screened, of those 90 were randomized and treated. Of 8 subjects who failed screening, 6 were due to screen failures, 1 was withdrawal by subject/guardian, 1 was due to other reasons.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A - BAY1097761 Active Dose 1
    Arm description
    		 Subject received BAY1097761 dose 1 by inhalation for up to 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pegylated adrenomedullin
    Investigational medicinal product code
    BAY1097761
    Other name
    PEG-ADM
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    dose 1, inhalation

    Arm title
    		 Part A - BAY1097761 Active Dose 2
    Arm description
    		 Subject received BAY1097761 dose 2 by inhalation for up to 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pegylated adrenomedullin
    Investigational medicinal product code
    BAY1097761
    Other name
    PEG-ADM
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    dose 2, inhalation

    Arm title
    		 Part A - Placebo
    Arm description
    		 Subject received matching placebo for up to 14 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    placebo, inhalation

    Number of subjects in period 1
    		Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Started
    29
    30
    31
    Completed
    17
    18
    21
    Not completed
    12
    12
    10
         Adverse event, serious fatal
    11
    7
    7
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    1
         Other reasons
    -
    1
    1
         Lost to follow-up
    -
    2
    -
         Protocol deviation
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A - BAY1097761 Active Dose 1
    Reporting group description
    		 Subject received BAY1097761 dose 1 by inhalation for up to 14 days.

    Reporting group title
    Part A - BAY1097761 Active Dose 2
    Reporting group description
    		 Subject received BAY1097761 dose 2 by inhalation for up to 14 days.

    Reporting group title
    Part A - Placebo
    Reporting group description
    		 Subject received matching placebo for up to 14 days.

    Reporting group values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo Total
    Number of subjects
    		 29 30 31 90
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.90 ( 16.82 ) 60.10 ( 17.80 ) 61.97 ( 11.26 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 8 7 11 26
        Male
    		 21 23 20 64

    End points

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    End points reporting groups
    Reporting group title
    Part A - BAY1097761 Active Dose 1
    Reporting group description
    		 Subject received BAY1097761 dose 1 by inhalation for up to 14 days.

    Reporting group title
    Part A - BAY1097761 Active Dose 2
    Reporting group description
    		 Subject received BAY1097761 dose 2 by inhalation for up to 14 days.

    Reporting group title
    Part A - Placebo
    Reporting group description
    		 Subject received matching placebo for up to 14 days.

    Subject analysis set title
    Full analysis set (FAS-A)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects randomized to Part A who received at least one inhalation and could provide baseline as well as post-randomization data for at least one CUI component. Subjects were analyzed as randomized.

    Subject analysis set title
    Safety analysis set (SAF-A)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomized to Part A who received at least one inhalation. Subjects were analyzed according to the intervention they actually received.

    Primary: Ventilator-free survival (VFS) in Part B subjects

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    End point title
    		 Ventilator-free survival (VFS) in Part B subjects [1]
    End point description
    Ventilator-free survival (VFS, number of subjects alive and not on invasive mechanical ventilation)
    End point type
    Primary
    End point timeframe
    in Part B at Study Day 28 (planned), while study terminated before Part B
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Study terminated before Part B, hence no results for this endpoint.
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: subjects
    Notes
    [2] - Study terminated before Part B initiation, Part A CUI results reported below.
    [3] - Study terminated before Part B initiation, Part A CUI results reported below.
    [4] - Study terminated before Part B initiation, Part A CUI results reported below.
    No statistical analyses for this end point

    Secondary: Clinical Utility Index (CUI) in Part A subjects

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    End point title
    		 Clinical Utility Index (CUI) in Part A subjects
    End point description
    Clinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1. CUI is derived from: Extravascular lung water index (EVLWi), Oxygenation index (OI), Non-pulmonary Sequential Organ Failure Assessment (npSOFA) score.
    End point type
    Secondary
    End point timeframe
    up to 28 days
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    29 [5]
    30 [6]
    31 [7]
    Units: scores
        median (confidence interval 95%)
    0.410 (0.293 to 0.525)
    0.642 (0.509 to 0.755)
    0.621 (0.488 to 0.731)
    Notes
    [5] - FAS-A
    [6] - FAS-A
    [7] - FAS-A
    Statistical analysis title
    		 Bayesian model for CUI dose 2 vs. placebo
    Statistical analysis description
    Bayesian mixed model for CUI with the overall estimates and active treatment vs. placebo results
    Comparison groups
    Part A - BAY1097761 Active Dose 2 v Part A - Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.155
         upper limit
    		 0.196
    Notes
    [8] - Posterior Probability of Difference Active Treatment - Placebo > 0 was 60.3%
    Statistical analysis title
    		 Bayesian model for CUI dose 1 vs. placebo
    Statistical analysis description
    Bayesian mixed model for CUI with the overall estimates and active treatment vs. placebo results
    Comparison groups
    Part A - BAY1097761 Active Dose 1 v Part A - Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.208
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.374
         upper limit
    		 -0.033
    Notes
    [9] - Posterior Probability of Difference Active Treatment - Placebo > 0 was 1.2%

    Secondary: VFS in Part A subjects

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    End point title
    		 VFS in Part A subjects
    End point description
    Ventilator-free survival (VFS, number of subjects alive and not on invasive mechanical ventilation)
    End point type
    Secondary
    End point timeframe
    At Day 28 and Day 60
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    29 [10]
    30 [11]
    31 [12]
    Units: subjects
        Day 28
    15
    20
    20
        Day 60
    15
    23
    23
    Notes
    [10] - SAF-A
    [11] - SAF-A
    [12] - SAF-A
    Statistical analysis title
    		 Bayesian for VFS at Day 28 dose 2 vs. placebo
    Statistical analysis description
    The estimates and active treatment vs. placebo for the Bayesian analysis for VFS at Study Day 28
    Comparison groups
    Part A - BAY1097761 Active Dose 2 v Part A - Placebo
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.212
         upper limit
    		 0.249
    Notes
    [13] - Posterior Probability of Difference Active Treatment - Placebo > 0 was 56.9%.
    Statistical analysis title
    		 Bayesian for VFS at Day 28 dose 1 vs. placebo
    Statistical analysis description
    The estimates and active treatment vs. placebo for the Bayesian analysis for VFS at Study Day 28
    Comparison groups
    Part A - BAY1097761 Active Dose 1 v Part A - Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.125
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.358
         upper limit
    		 0.112
    Notes
    [14] - Posterior Probability of Difference Active Treatment - Placebo > 0 was 16.0%.

    Secondary: All-cause mortality in Part A and Part B subjects

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    End point title
    		 All-cause mortality in Part A and Part B subjects
    End point description
    All-cause mortality is defined as proportion of deceased study subjects at a corresponding study day.
    End point type
    Secondary
    End point timeframe
    At Day 28, Day 60 and Day 90 (Part A only, study terminated before Part B)
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    29 [15]
    30 [16]
    31 [17]
    Units: subjects
        Day 28
    7
    6
    6
        Day 60
    9
    7
    7
        Day 90
    11
    7
    7
    Notes
    [15] - SAF-A
    [16] - SAF-A
    [17] - SAF-A
    No statistical analyses for this end point

    Secondary: Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B subjects

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    End point title
    		 Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B subjects
    End point description
    Proportion of participants who still require invasive mechanical ventilation support at Study Day 28 / 60
    End point type
    Secondary
    End point timeframe
    At Day 28 and Day 60 (Part A only, study terminated before Part B)
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    29 [18]
    30 [19]
    31 [20]
    Units: subjects
        Day 28
    7
    4
    5
        Day 60
    5
    0
    1
    Notes
    [18] - FAS-A
    [19] - FAS-A
    [20] - FAS-A
    No statistical analyses for this end point

    Secondary: Ventilator-free days (VFDs) in Part A and Part B subjects

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    End point title
    		 Ventilator-free days (VFDs) in Part A and Part B subjects
    End point description
    End point type
    Secondary
    End point timeframe
    Within Day 28 and Day 60 (Part A only, study terminated before Part B)
    End point values
    		 Part A - BAY1097761 Active Dose 1 Part A - BAY1097761 Active Dose 2 Part A - Placebo
    Number of subjects analysed
    29 [21]
    30 [22]
    31 [23]
    Units: days
    arithmetic mean (standard deviation)
        Day 28
    9.17 ( 10.35 )
    10.73 ( 9.37 )
    9.84 ( 9.13 )
        Day 60
    25.72 ( 25.80 )
    35.03 ( 21.10 )
    32.35 ( 22.05 )
    Notes
    [21] - SAF-A
    [22] - SAF-A
    [23] - SAF-A
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    A treatment-emergent AE was defined as an AE observed or reported after the first administration of study drug or if it started before the first administration of study drug and worsens on treatment, and not later than 2 days after end of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Part A - BAY1097761 Active Dose 1
    Reporting group description
    		 Subject received BAY1097761960 dose 1 by inhalation for up to 14 days.

    Reporting group title
    Part A - Placebo
    Reporting group description
    		 Subject received matching placebo for up to 14 days.

    Reporting group title
    Part A - BAY1097761 Active Dose 2
    Reporting group description
    		 Subject received BAY1097761960 dose 2 by inhalation for up to 14 days.

    Serious adverse events
    		 Part A - BAY1097761 Active Dose 1 Part A - Placebo Part A - BAY1097761 Active Dose 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 29 (34.48%)
    13 / 31 (41.94%)
    14 / 30 (46.67%)
         number of deaths (all causes)
    11
    7
    7
         number of deaths resulting from adverse events
    3
    6
    5
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Endotracheal intubation complication
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weaning failure
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuromyopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quadriparesis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Diaphragmatic rupture
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia serratia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A - BAY1097761 Active Dose 1 Part A - Placebo Part A - BAY1097761 Active Dose 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 29 (51.72%)
    17 / 31 (54.84%)
    18 / 30 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    1
    Hypotension
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    3
    Jugular vein thrombosis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    2
    Atrial fibrillation
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 31 (3.23%)
    3 / 30 (10.00%)
         occurrences all number
    4
    2
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 31 (16.13%)
    3 / 30 (10.00%)
         occurrences all number
    1
    5
    3
    Thrombocytopenia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 31 (9.68%)
    0 / 30 (0.00%)
         occurrences all number
    1
    3
    0
    Nausea
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences all number
    2
    2
    1
    Pulmonary embolism
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    0
    3
    Insomnia
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    2
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 31 (0.00%)
    5 / 30 (16.67%)
         occurrences all number
    3
    0
    5
    Infections and infestations
    Herpes simplex reactivation
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 31 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    2
    Septic shock
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Pneumonia
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 31 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    3
    0
    3
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 31 (3.23%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 31 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    3
    0
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2021
    Amendment 1 (v2.0) dated 31 MAR 2021: Version to implement recommendations of the independent Data Monitoring Committee.
    18 May 2022
    Amendment 2 (v3.0) dated 18 MAY 2022: Version to implement changes resulting from pandemic impact on ICUs and strain on the hospital workforce.

    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.
    Study terminated after Part A, before Part B initiation.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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