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    Clinical Trial Results:
    The Impact of Camostat Mesilate on COVID-19 Infection: An investigator-initiated randomized, placebo-controlled, phase IIa trial

    Summary
    EudraCT number
    		 2020-001200-42
    Trial protocol
    		 DK  
    Global end of trial date
    22 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2023
    First version publication date
    18 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CamoCO-19-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04321096
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Blv 99, Aarhus N, Denmark,
    Public contact
    Ole Schmeltz Søgaard, Department of Infecitous Diseases, Aarhus University Hospital, 0045 23886636, olesoega@rm.dk
    Scientific contact
    Ole Schmeltz Søgaard, Department of Infecitous Diseases, Aarhus University Hospital, 0045 23886636, olesoega@rm.dk
    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
    22 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objective of the study is to evaluate the efficacy of Camostat Mesilate against COVID-19 infection among adults with COVID-19 infection.
    Protection of trial subjects
    Safety will be monitored by vital signs, clinical laboratory tests, history and physical examinations if needed and the rate and severity of AE. If indicated in the opinion of the investigator, a physical examination will be performed ad hoc. Routine biochemistry (safety) will be performed within +/-12 hours of the first dosing of camostat mesilate. Subsequent dosing will be postponed in case of unacceptable laboratory values in the judgment of the investigator. Laboratory tests may be repeated, as clinically indicated, to obtain acceptable values before participants are withdrawn from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 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
    Sweden: 6
    Country: Number of subjects enrolled
    Denmark: 199
    Worldwide total number of subjects
    205
    EEA total number of subjects
    205
    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)
    116
    From 65 to 84 years
    79
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 The site PI (physician) or delegated study physician/nurse will obtain written informed consent from each subject before any study-specific activity is initiated, using a consent form prospectively approved by The Ethics Committee.

    Pre-assignment
    Screening details
    		 Less than 48 hours since time of hospital admission OR if hospital-acquired COVID-19 is suspected, less than 48 hrs since onset of symptoms

    Period 1
    Period 1 title
    Dosing/follow-up (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
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    x3 daily for 5 days

    Arm title
    		 Camostat
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Camostat mesilate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg x3 daily for 5 days

    Number of subjects in period 1
    		Placebo Camostat
    Started
    68
    137
    Completed
    68
    137

    Baseline characteristics

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

    Reporting group title
    Camostat
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Camostat Total
    Number of subjects
    		 68 137 205
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 61 (55 to 74) 62 (51 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 27 55 82
        Male
    		 41 82 123
    Viral load
    Units: copies/ml
        arithmetic mean (standard deviation)
    		 4.9 ± 1.7 4.6 ± 1.8 -

    End points

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

    Reporting group title
    Camostat
    Reporting group description
    		 -

    Primary: Clinical improvement

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    End point title
    		 Clinical improvement
    End point description
    End point type
    Primary
    End point timeframe
    30 daus
    End point values
    		 Placebo Camostat
    Number of subjects analysed
    68
    137
    Units: days
        median (inter-quartile range (Q1-Q3))
    5 (2 to 10)
    5 (3 to 7)
    Statistical analysis title
    		 Kaplan-Meier
    Comparison groups
    Placebo v Camostat
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3107
    Method
    		 Logrank
    Confidence interval

    Secondary: During of oxygen supplementation

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    End point title
    		 During of oxygen supplementation
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Placebo Camostat
    Number of subjects analysed
    68
    137
    Units: days
        median (inter-quartile range (Q1-Q3))
    4 (2 to 8)
    4 (2 to 7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Camostat
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Camostat
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 68 (11.76%)
    27 / 137 (19.71%)
         number of deaths (all causes)
    4
    8
         number of deaths resulting from adverse events
    4
    8
    Investigations
    Death
         subjects affected / exposed
    4 / 68 (5.88%)
    8 / 137 (5.84%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 8
    Blood and lymphatic system disorders
    Thromboembolic event
         subjects affected / exposed
    0 / 68 (0.00%)
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    0 / 68 (0.00%)
    6 / 137 (4.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Camostat
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 68 (4.41%)
    3 / 137 (2.19%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 137 (1.46%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 68 (2.94%)
    1 / 137 (0.73%)
         occurrences all number
    2
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/3390385
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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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