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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-Concept, Phase IIa Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Patients With Moderate to Severe COVID-19

    Summary
    EudraCT number
    		 2021-000344-21
    Trial protocol
    		 FR   HU   ES   BG   IT   RO  
    Global end of trial date
    05 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2023
    First version publication date
    10 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MP1032-CT05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04932941
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MetrioPharm AG
    Sponsor organisation address
    Europaallee 41, Zurich, Switzerland, 8004
    Public contact
    Clinical Trials Group, MetrioPharm Deutschland GmbH, +49 30 338439502, info@metriopharm.com
    Scientific contact
    Clinical Trials Group, MetrioPharm Deutschland GmbH, +49 30 338439502, info@metriopharm.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
    05 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19).
    Protection of trial subjects
    This study was conducted in accordance with the accepted version of the Declaration of Helsinki and/or all relevant federal regulations as set forth in Parts 50, 56, 312, Subpart D, of Title 21 of the US Code of Federal Regulations; EU 536/2014, Annex 1, D, 17 (a); in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use good clinical practice (GCP) guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted. An independent data monitoring committee (IDMC) was established which reviewed unblinded data on a regular basis and gave recommendations on the study continuation. In addition, criteria that might have warranted the discontinuation of an individual subject from study or even the termination of the whole study were in place.
    Background therapy
    		 All subjects received standard of care.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2021
    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
    Romania: 39
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Bulgaria: 57
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Hungary: 24
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    132
    EEA total number of subjects
    132
    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)
    70
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 20 sites in 6 countries from 19 October 2021 to 05 September 2022. Subjects were randomized in the 2:1 ratio to treatment groups using an Interactive Web Response System (IWRS).

    Pre-assignment
    Screening details
    		 A total of 134 subjects were screened, of which 132 subjects were randomized to either the MP1032 plus standard of care (SoC) or the placebo plus SoC group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MP1032 300 mg + SoC
    Arm description
    		 Subjects received MP1032, 300 milligrams (mg) hard gelatin capsules orally, twice daily (BID) with hospital selected SoC procedure for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MP1032
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received MP1032 300 mg hard gelatin capsules orally.

    Arm title
    		 Placebo + SoC
    Arm description
    		 Subjects received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
    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
    Subjects received placebo, matched to MP1032 hard gelatin capsules orally.

    Number of subjects in period 1
    		MP1032 300 mg + SoC Placebo + SoC
    Started
    87
    45
    Completed
    73
    38
    Not completed
    14
    7
         Consent withdrawn by subject
    7
    4
         Unspecified
    4
    2
         Lost to follow-up
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MP1032 300 mg + SoC
    Reporting group description
    		 Subjects received MP1032, 300 milligrams (mg) hard gelatin capsules orally, twice daily (BID) with hospital selected SoC procedure for 28 days.

    Reporting group title
    Placebo + SoC
    Reporting group description
    		 Subjects received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.

    Reporting group values
    		 MP1032 300 mg + SoC Placebo + SoC Total
    Number of subjects
    		 87 45 132
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.6 ( 13.83 ) 62.3 ( 14.15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 19 55
        Male
    		 51 26 77
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 1 6
        Not Hispanic or Latino
    		 79 44 123
        Unknown or Not Reported
    		 3 0 3
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 87 45 132

    End points

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    End points reporting groups
    Reporting group title
    MP1032 300 mg + SoC
    Reporting group description
    		 Subjects received MP1032, 300 milligrams (mg) hard gelatin capsules orally, twice daily (BID) with hospital selected SoC procedure for 28 days.

    Reporting group title
    Placebo + SoC
    Reporting group description
    		 Subjects received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.

    Primary: Percentage of Subjects With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14

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    End point title
    		 Percentage of Subjects With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14
    End point description
    Disease progression was defined as the percentage of subjects who were not alive or who had respiratory failure (RF). RF was defined as subjects who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care; 6) Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Total score range was 1 to 8 where, higher score=improvement in clinical status. Intention-to-Treat (ITT) Population. “Number of subjects analysed” signifies who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    At Day 14
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    43
    Units: Percentage of subjects
        number (confidence interval 95%)
    9.8 (4.307 to 18.321)
    11.6 (3.885 to 25.083)
    Statistical analysis title
    		 MP1032 300 mg + SoC Versus Placebo + SoC
    Comparison groups
    MP1032 300 mg + SoC v Placebo + SoC
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.962
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Common risk difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.634
         upper limit
    		 11.081

    Secondary: Percentage of Subjects With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28

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    End point title
    		 Percentage of Subjects With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28
    End point description
    Disease progression was defined as the percentage of subjects who were not alive or who had RF. RF was defined as subjects who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care; 6) Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Total score range was 1 to 8 where, higher score indicates improvement in clinical status. ITT Population. Here “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    79
    41
    Units: Percentage of subjects
        number (confidence interval 95%)
    2.5 (0.308 to 8.848)
    2.4 (0.062 to 12.855)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Disease Resolution at Day 28

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    End point title
    		 Percentage of Subjects With Disease Resolution at Day 28
    End point description
    Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. Intention-to-Treat (ITT) Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    79
    41
    Units: Percentage of subjects
        number (confidence interval 95%)
    97.5 (91.152 to 99.692)
    97.6 (87.145 to 99.938)
    No statistical analyses for this end point

    Secondary: All-cause Mortality Rate up to Day 28

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    End point title
    		 All-cause Mortality Rate up to Day 28
    End point description
    All-cause Mortality Rate was the percentage of subjects in each treatment group who died at Day 28. The ITT Set corresponded with the randomized set and included all randomized subjects, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    42
    Units: Percentage of participants
        number (confidence interval 95%)
    2.4 (0.297 to 8.534)
    2.4 (0.060 to 12.566)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28

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    End point title
    		 Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28
    End point description
    The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale was defined as follows: 1=Death, 2=Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO), 3=Hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4=Hospitalized, requiring supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons), 7=Not hospitalized, limitation on activities, and/or requiring home oxygen, 8=Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score related to COVID-19 at Day 28 were reported. ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    87
    45
    Units: Score on a scale
        least squares mean (standard error)
    3.542 ( 0.130 )
    3.612 ( 0.174 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Disease Resolution at Day 14

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    End point title
    		 Percentage of Subjects With Disease Resolution at Day 14
    End point description
    Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. ITT Population.
    End point type
    Secondary
    End point timeframe
    At Day 14
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    43
    Units: Percentage of subjects
        number (confidence interval 95%)
    84.1 (74.417 to 91.280)
    72.1 (56.331 to 84.671)
    No statistical analyses for this end point

    Secondary: All-cause Mortality Rate up to Day 14 and Day 60

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    End point title
    		 All-cause Mortality Rate up to Day 14 and Day 60
    End point description
    The percentage of subjects who died by Day 14 and Day 60 were reported. The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and, "n" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Up to Day 14 and Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    83
    43
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 14 (n=83,43)
    1.2 (0.030 to 6.531)
    2.3 (0.059 to 12.289)
        Day 60 (n=80,41)
    3.8 (0.780 to 10.570)
    4.9 (0.596 to 16.533)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14

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    End point title
    		 Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14
    End point description
    The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care; 6) Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Here, higher score indicates improvement in clinical status. The change from baseline in NIAID clinical status score by Visit Days were reported. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    43
    Units: Score on a scale
        least squares mean (standard error)
    2.987 ( 0.174 )
    2.543 ( 0.242 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28

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    End point title
    		 Percentage of Subjects Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28
    End point description
    Percentage of subjects who required invasive mechanical ventilation/ECMO or who died by Day 14 and Day 28 were reported. The ITT Set corresponded with the randomized set and included all randomized subjects, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "number of subjects analyzed” signifies subjects who were evaluable for this endpoint and "n" signifies to number of subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    At Day 14 and Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    43
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 14 (n=82,43)
    1.2 (0.031 to 6.608)
    2.3 (0.059 to 12.289)
        Day 28 (n=79,41)
    2.5 (0.308 to 8.848)
    2.4 (0.062 to 12.855)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit

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    End point title
    		 Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit
    End point description
    The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and "n" signifies number of subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    86
    44
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 2 (n=86,44)
    0.1 ( 0.42 )
    0.0 ( 0.21 )
        Day 3 (n=85,44)
    0.2 ( 0.73 )
    0.1 ( 0.46 )
        Day 4 (n=85,44)
    0.2 ( 0.83 )
    0.2 ( 0.53 )
        Day 5 (n=84,44)
    0.4 ( 0.88 )
    0.3 ( 0.70 )
        Day 6 (n=81,44)
    0.6 ( 1.01 )
    0.4 ( 0.76 )
        Day 7 (n=83,43)
    1.2 ( 1.44 )
    1.0 ( 1.34 )
        Day 8 (n=76,43)
    1.6 ( 1.60 )
    1.6 ( 1.75 )
        Day 9 (n=75,39)
    2.0 ( 1.70 )
    1.7 ( 1.77 )
        Day 10 (n=74,38)
    2.2 ( 1.69 )
    1.7 ( 1.83 )
        Day 11 (n=73,38)
    2.3 ( 1.65 )
    1.9 ( 1.82 )
        Day 12 (n=70,37)
    2.5 ( 1.66 )
    1.9 ( 1.82 )
        Day 13 (n=68,34)
    2.7 ( 1.64 )
    2.2 ( 1.71 )
        Day 14 (n=82,43)
    3.0 ( 1.47 )
    2.6 ( 1.72 )
        Day 28 (n=78,40)
    3.7 ( 0.89 )
    3.7 ( 0.51 )
        Day 60 (n=74,38)
    3.7 ( 1.01 )
    3.8 ( 0.49 )
    No statistical analyses for this end point

    Secondary: Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale

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    End point title
    		 Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale
    End point description
    The NIAID scale is an assessment of clinical status on a given study day and is defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care; 6) Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Subjects who did not improve at least 1 category on the NIAID scale or died before Day 28 were censored at Day 28. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    81
    40
    Units: Days
        median (confidence interval 95%)
    7 (7.000 to 8.000)
    7 (6.000 to 8.000)
    No statistical analyses for this end point

    Secondary: Odds Ratio for Subjects With Clinical Status Improvement From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28

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    End point title
    		 Odds Ratio for Subjects With Clinical Status Improvement From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28
    End point description
    The NIAID scale is an assessment of clinical status on a given study day and is defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care; 6) Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Higher score = improvement in clinical status. The odds ratio at Day 14 and Day 28 was analyzed using a logistic regression with consideration of the 2 stratification factors. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and and “n” signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14 and Day 28
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    82
    43
    Units: Odds Ratio
    number (not applicable)
        Day 14 (n=82,43)
    1.476
    1.0
        Day 28 (n=78,40)
    0.000
    1.0
    No statistical analyses for this end point

    Secondary: Time to Discharge by Day 28 and Day 60

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    End point title
    		 Time to Discharge by Day 28 and Day 60
    End point description
    Time to discharge i.e., the total duration of subject hospitalization from baseline to discharge at Day 28 and Day 60 was reported. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and "n" signifies number of subjects evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 28 and Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    83
    42
    Units: Days
    median (confidence interval 95%)
        Day 28 (n=82,41)
    9 (8.000 to 10.000)
    10 (8.000 to 13.000)
        Day 60 (n=83,42)
    9 (8.000 to 10.000)
    10 (8.000 to 13.000)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60

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    End point title
    		 Percentage of Subjects Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60
    End point description
    Percentage of subjects who are alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported. ITT Population. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and "n" signifies number of subjects evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    At Day 14, Day 28 and Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    76
    39
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 14 (n=76,39)
    67.1 (55.374 to 77.457)
    66.7 (49.783 to 80.912)
        Day 28 (n=69,38)
    91.3 (82.028 to 96.742)
    92.1 (78.623 to 98.341)
        Day 60 (n=67,31)
    95.5 (87.467 to 99.067)
    93.5 (78.578 to 99.209)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
    End point description
    An Adverse Event (AE) was any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. TEAE was defined as any adverse event which starts or worsens at any time after initiation of study drug until the end of the follow-up period at Day 60. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Number of participants with TEAEs and Serious TEAEs were reported. The Safety Set included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    86
    45
    Units: Subjects
        Subjects with TEAEs
    46
    26
        Subjects with Serious TEAEs
    5
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Change in Vital Sign

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    End point title
    		 Number of Subjects With Clinically Significant Change in Vital Sign
    End point description
    Vital sign parameters included of systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature. Any clinically significant change in vital signs were judged by the investigator. Number of subjects with clinically significant change in vital sign values were reported. The Safety Set included all randomized subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    86
    45
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Physical Examinations

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    End point title
    		 Number of Subjects With Clinically Significant Abnormalities in Physical Examinations
    End point description
    Physical examination included examination of Body System (BS) which included respiratory, cardiovascular, dermatological, neurological, and gastrointestinal system. Any clinically significant abnormalities in physical examination were judged by the investigator. Number of subjects with clinically significant abnormalities in physical examinations findings were reported. The Safety Set included all randomized subjects who received at least 1 dose of study drug. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint and “n” signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    86
    45
    Units: Subjects
        BS: Abdomen-Baseline(n=86,45)
    0
    1
        BS: Abdomen-Day 8(n=6,3)
    0
    1
        BS: Cardiovascular-Baseline(n=86,45)
    4
    2
        BS: Cardiovascular-Day 8(n=5,4)
    0
    1
        BS: Cardiovascular-Day 14(n=6,2)
    2
    0
        BS: Head,Eyes,Ears,Nose,Throat-Baseline(n=86,45)
    8
    7
        BS: Head,Eyes,Ears,Nose,Throat-Day 8(n=21,9)
    0
    2
        BS: Head,Eyes,Ears,Nose,Throat-Day 14(n=10,7)
    0
    2
        BS: Neurologic-Baseline(n=85,45)
    0
    1
        BS: Neurologic-Day 14(n=3,1)
    0
    1
        BS: Other-Baseline(n=16,8)
    14
    8
        BS: Other-Day 8(n=8,7)
    1
    2
        BS: Other-Day 14(n=7,4)
    0
    1
        BS: Respiratory-Baseline(n=86,45)
    38
    22
        BS: Respiratory-Day 8(n=45,22)
    4
    2
        BS: Respiratory-Day 14(n=28,11)
    0
    1
        BS: Dermatologic-Baseline(n=85,45)
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Results

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    End point title
    		 Number of Subjects With Clinically Significant Abnormalities in Clinical Laboratory Results
    End point description
    Clinical laboratory tests included biochemistry, hematology and urinalysis. Any clinically significant abnormalities in clinical laboratory results were judged by the investigator. Number of subjects with clinically significant abnormalities in laboratory results were reported. The Safety Set included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 60
    End point values
    		 MP1032 300 mg + SoC Placebo + SoC
    Number of subjects analysed
    86
    45
    Units: Subjects
    23
    22
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of MP1032

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of MP1032 [1]
    End point description
    Cmax of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. The Pharmacokinetic (PK) Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "n" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    4
    Units: nanogram per milliliter (ng/ml)
    geometric mean (geometric coefficient of variation)
        Day 1 (n=4)
    284.15 ( 170.38 )
        Day 7 (n=3)
    279.29 ( 37.85 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032

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    End point title
    		 Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 [2]
    End point description
    AUC0-t of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "n" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    4
    Units: hour per nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Day 1 (n=4)
    350.40 ( 42.87 )
        Day 7 (n=3)
    251.24 ( 28.72 )
    No statistical analyses for this end point

    Secondary: Apparent Elimination Rate Constant (Kel) of MP1032

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    End point title
    		 Apparent Elimination Rate Constant (Kel) of MP1032 [3]
    End point description
    Kel was calculated using negative of the estimated slope of the linear regression of the ln-transformed plasma concentration versus time profile in the terminal elimination phase. Kel of MP1032 in plasma were reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    4
    Units: per hour
        arithmetic mean (standard deviation)
    0.7162 ( 0.8851 )
    No statistical analyses for this end point

    Secondary: Apparent Body Clearance (CL/F) of MP1032

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    End point title
    		 Apparent Body Clearance (CL/F) of MP1032 [4]
    End point description
    Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    3
    Units: liter per hour
        geometric mean (geometric coefficient of variation)
    625.05 ( 26.09 )
    No statistical analyses for this end point

    Secondary: Apparent Volume of Distribution (Vz/F) of MP1032

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    End point title
    		 Apparent Volume of Distribution (Vz/F) of MP1032 [5]
    End point description
    Vz/F was estimated as Dose/(Kel x AUC0-inf). Vz/F of MP1032 in plasma was reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, “number of subjects analysed” signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    3
    Units: Liter
        geometric mean (geometric coefficient of variation)
    1494.56 ( 130.81 )
    No statistical analyses for this end point

    Secondary: Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032

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    End point title
    		 Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 [6]
    End point description
    Ctrough of MP1032 in plasma was reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "n" signifies subjects who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-dose concentration (Day 2, Day 7, and Day 8)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    4
    Units: ng/ml
    arithmetic mean (standard deviation)
        Day 2 (n=4)
    9.74 ( 11.27 )
        Day 7 (n=4)
    60.79 ( 121.59 )
        Day 8 (n=3)
    66.67 ( 115.48 )
    No statistical analyses for this end point

    Secondary: Average Observed Plasma Concentration at Steady State of MP1032

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    End point title
    		 Average Observed Plasma Concentration at Steady State of MP1032 [7]
    End point description
    Average observed plasma concentration at steady state of MP1032 was reported. The PK Analysis Set included all the subjects who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "n" signifies subjects who were evaluable at specified timepoints and '99999' indicates that at 8 hours geomean and CV% data was not estimated due to below limit of quantification (BLOQ).
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic Parameters were planned to be analysed for the test arm (subjects who received active study drug) only.
    End point values
    		 MP1032 300 mg + SoC
    Number of subjects analysed
    4
    Units: ng/ml
    geometric mean (geometric coefficient of variation)
        Day 1: pre-dose (n=4)
    0 ( 0 )
        Day 1: 0.16 hours post-dose (n=4)
    175.7 ( 322.8 )
        Day 1: 0.33 hours post-dose (n=4)
    200.1 ( 84.6 )
        Day 1: 0.5 hours post-dose (n=4)
    140.4 ( 55.3 )
        Day 1: 1 hour post-dose (n=4)
    64.39 ( 34.5 )
        Day 1: 2 hours post-dose (n=4)
    28.55 ( 145.5 )
        Day 1: 8 hours post-dose (n=4)
    15.48 ( 29.7 )
        Day 1: 24 hours post-dose (n=4)
    19.45 ( 7.5 )
        Day 7: pre-dose (n=4)
    243.2 ( 0 )
        Day 7: 0.16 hours post-dose (n=3)
    187.3 ( 53.3 )
        Day 7: 0.33 hours post-dose (n=3)
    281.5 ( 55.4 )
        Day 7: 0.5 hours post-dose (n=3)
    178.8 ( 41.1 )
        Day 7: 1 hour post-dose (n=3)
    94.42 ( 117.8 )
        Day 7: 2 hours post-dose (n=3)
    79.55 ( 155.0 )
        Day 7: 8 hours post-dose (n=3)
    99999 ( 99999 )
        Day 7: 24 hours post-dose (n=3)
    200.0 ( 0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 60
    Adverse event reporting additional description
    Reported adverse events (AEs) are treatment-emergent AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). Serious and Other AEs were collected for safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    MP1032 300 mg + SoC
    Reporting group description
    		 Subjects received MP1032 300 mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.

    Reporting group title
    Placebo + SoC
    Reporting group description
    		 Subjects received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.

    Serious adverse events
    		 MP1032 300 mg + SoC Placebo + SoC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 86 (5.81%)
    3 / 45 (6.67%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MP1032 300 mg + SoC Placebo + SoC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 86 (53.49%)
    26 / 45 (57.78%)
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Respiratory failure
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Emotional disorder
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Investigations
    Activated partial thromboplastin time shortened
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 86 (8.14%)
    6 / 45 (13.33%)
         occurrences all number
    7
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 86 (2.33%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Blood glucose increased
         subjects affected / exposed
    1 / 86 (1.16%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Blood pressure increased
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 86 (4.65%)
    2 / 45 (4.44%)
         occurrences all number
    4
    2
    Intestinal transit time increased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Bradycardia
         subjects affected / exposed
    4 / 86 (4.65%)
    2 / 45 (4.44%)
         occurrences all number
    4
    2
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Blood disorder
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Leukocytosis
         subjects affected / exposed
    3 / 86 (3.49%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Neutrophilia
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Thrombocytosis
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Ulcerative keratitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 45 (0.00%)
         occurrences all number
    5
    0
    Dry mouth
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Hepatitis toxic
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hand dermatitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    HIV infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Hepatic infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Toxic shock syndrome
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 86 (3.49%)
    2 / 45 (4.44%)
         occurrences all number
    3
    2
    Hyperglycaemia
         subjects affected / exposed
    3 / 86 (3.49%)
    4 / 45 (8.89%)
         occurrences all number
    3
    4
    Hyperkalaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    9 / 86 (10.47%)
    4 / 45 (8.89%)
         occurrences all number
    9
    4
    Hypoglycaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 86 (2.33%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1

    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? No

    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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    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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