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    Clinical Trial Results:
    A randomized, placebo controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19

    Summary
    EudraCT number
    2020-002345-42
    Trial protocol
    ES   FR  
    Global end of trial date
    29 Jun 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    998
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04576728
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Biotest AG
    Sponsor organisation address
    Landsteinerstr. 5, Dreieich, Germany, 63303
    Public contact
    Dr. med. Andrea Wartenberg-Demand, Biotest AG, +49 61038010, andrea.wartenberg-demand@biotest.com
    Scientific contact
    Dr. med. Andrea Wartenberg-Demand, Biotest AG, +49 61038010, andrea.wartenberg-demand@biotest.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
    25 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared with placebo treatment in adult hospitalized subjects with severe Coronavirus Disease 2019 (COVID-19). Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin were evaluated in all subjects.
    Protection of trial subjects
    To mitigate previously identified and potential (class) risks certain exclusion criteria were implemented. Furthermore these risks were monitored through (1) defined adverse events of special interest (AESI), (2) general AE reporting and (3) through regular assessment of local clinical laboratory parameters. A Data Safety Monitoring Board (DSMB) was convened to review cumulative safety and efficacy data, and to monitor demographics and balance between treatment groups.
    Background therapy
    Standard of care
    Evidence for comparator
    Placebo
    Actual start date of recruitment
    06 Oct 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
    Russian Federation: 86
    Country: Number of subjects enrolled
    Brazil: 40
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    France: 32
    Worldwide total number of subjects
    166
    EEA total number of subjects
    40
    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)
    111
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The first subject’s first visit (date of first enrollment) was on 06-OCT-2020 and the last subject’s last visit (date of last completed) was on 29-JUN-2021

    Pre-assignment
    Screening details
    Laboratory-confirmed SARS-CoV-2 infection, diagnosis of community-acquired severe COVID-19 within 10 days after hospital-admission, age ≥18 years, subject must receive SoC treatment for COVID-19.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The matching placebo had similar appearance to trimodulin which enabled maintaining the treatment blinding. To ensure blinding, vials were covered with transparent colored foils in accordance with studyspecific guidance for coating of vials with green foil.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Trimodulin
    Arm description
    Trimodulin (BT588; normal polyvalent immunoglobulin M [IgM], immunoglobulin A [IgA] and immunoglobulin G [IgG] from human plasma) was administered via intravenous infusion (IV) at a dose volume of 3.65 mL/kg body weight (BW)/day (corresponding to a dose of 182.6 mg trimodulin/kg BW/day). The approximate concentration of IgM in trimodulin was 18-28%, IgA was 15-27% and IgG was 48-66%.
    Arm type
    Experimental

    Investigational medicinal product name
    Trimodulin
    Investigational medicinal product code
    BT588
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trimodulin volume administered was 3.65 mL/kg body weight (BW)/day, corresponding to 182.6 mg trimodulin/kg BW/day. Each subject received the trimodulin once daily on 5 consecutive days (day 1 through day 5). On day 1 of infusion, the initial infusion rate was set to 0.1 mL/min. The rate was to be raised in steps of 0.1 mL every 10 minutes until the target infusion rate of a maximum 0.5 mL/min was reached, if it was well tolerated by the subject. For subsequent infusions (day 2 through day 5) the infusion was started with the maximum tolerated infusion rate determined on day 1 for that subject, usually the target rate of 0.5 mL/min (30 mL/hour).

    Arm title
    Placebo
    Arm description
    Subjects were treated with placebo containing 1% human albumin solution. The dose to be administered was 3.65 mL/kg body weight (BW)/day, corresponding to a dose of 36.5 mg albumin/kg BW/day, administered as intravenous infusion on 5 consecutive days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The placebo volume administered was 3.65 mL/kg body weight (BW)/day. Each subject received placebo once daily on 5 consecutive days (day 1 through day 5). On day 1 of infusion, the initial infusion rate was set to 0.1 mL/min. The rate was to be raised in steps of 0.1 mL every 10 minutes until the target infusion rate of a maximum 0.5 mL/min was reached, if it was well tolerated by the subject. For subsequent infusions (day 2 through day 5) the infusion was started with the maximum tolerated infusion rate determined on day 1 for that subject, usually the target rate of 0.5 mL/min (30 mL/hour).

    Number of subjects in period 1
    Trimodulin Placebo
    Started
    84
    82
    Completed
    64
    63
    Not completed
    20
    19
         Adverse event, serious fatal
    18
    15
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trimodulin
    Reporting group description
    Trimodulin (BT588; normal polyvalent immunoglobulin M [IgM], immunoglobulin A [IgA] and immunoglobulin G [IgG] from human plasma) was administered via intravenous infusion (IV) at a dose volume of 3.65 mL/kg body weight (BW)/day (corresponding to a dose of 182.6 mg trimodulin/kg BW/day). The approximate concentration of IgM in trimodulin was 18-28%, IgA was 15-27% and IgG was 48-66%.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were treated with placebo containing 1% human albumin solution. The dose to be administered was 3.65 mL/kg body weight (BW)/day, corresponding to a dose of 36.5 mg albumin/kg BW/day, administered as intravenous infusion on 5 consecutive days.

    Reporting group values
    Trimodulin Placebo Total
    Number of subjects
    84 82 166
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    55 56 111
        From 65-84 years
    29 26 55
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    34 32 66
        Male
    50 50 100
    Subject analysis sets

    Subject analysis set title
    Deterioration/mortality rate:
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all subjects of the safety analysis set (SAF), who had at least one post-dose assessment. Subjects were analyzed as randomized. Assessment of primary efficacy was based on a composite of two parameters assessed by the 9-category ordinal scale: the clinical deterioration rate (score of 6 or 7, assessed between day 6 and day 29) plus the 28-day all-cause mortality rate (score of 8, assessed between day 1 and day 29).

    Subject analysis sets values
    Deterioration/mortality rate:
    Number of subjects
    166
    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)
    111
        From 65-84 years
    55
        85 years and over
    0
    Age continuous
    Units:
        
    60 ( )
    Gender categorical
    Units: Subjects
        Female
    66
        Male
    100

    End points

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    End points reporting groups
    Reporting group title
    Trimodulin
    Reporting group description
    Trimodulin (BT588; normal polyvalent immunoglobulin M [IgM], immunoglobulin A [IgA] and immunoglobulin G [IgG] from human plasma) was administered via intravenous infusion (IV) at a dose volume of 3.65 mL/kg body weight (BW)/day (corresponding to a dose of 182.6 mg trimodulin/kg BW/day). The approximate concentration of IgM in trimodulin was 18-28%, IgA was 15-27% and IgG was 48-66%.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were treated with placebo containing 1% human albumin solution. The dose to be administered was 3.65 mL/kg body weight (BW)/day, corresponding to a dose of 36.5 mg albumin/kg BW/day, administered as intravenous infusion on 5 consecutive days.

    Subject analysis set title
    Deterioration/mortality rate:
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all subjects of the safety analysis set (SAF), who had at least one post-dose assessment. Subjects were analyzed as randomized. Assessment of primary efficacy was based on a composite of two parameters assessed by the 9-category ordinal scale: the clinical deterioration rate (score of 6 or 7, assessed between day 6 and day 29) plus the 28-day all-cause mortality rate (score of 8, assessed between day 1 and day 29).

    Primary: Composite: Clinical Deterioation/Mortality

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    End point title
    Composite: Clinical Deterioation/Mortality
    End point description
    Composite endpoint of clinical deterioration rate plus 28-day all-cause mortality rate
    End point type
    Primary
    End point timeframe
    Clinical deterioration rate (score=6 to 7) between day 6 and day 29 28-day all-cause mortality rate (score=8) between day 1 and day 29
    End point values
    Trimodulin Placebo Deterioration/mortality rate:
    Number of subjects analysed
    84
    82
    166
    Units: Number/Percentage of Subjects
        Number of Subjects Analysed
    28
    28
    56
        Percentage of Subjects Analysed
    33
    34
    33
    Statistical analysis title
    Primary Analysis
    Comparison groups
    Trimodulin v Placebo
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.912
    Method
    Chi-squared
    Parameter type
    Difference in Proportion
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.56
         upper limit
    15.74

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of informed consent until the end-of-follow-up visit on day 29 [+3].
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Safety Analysis Set (SAF)
    Reporting group description
    All subjects, who have been randomized and received at least one dose of IMP. Subjects were analyzed according to the treatment received.

    Serious adverse events
    Safety Analysis Set (SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 166 (38.55%)
         number of deaths (all causes)
    33
         number of deaths resulting from adverse events
    33
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    8 / 166 (4.82%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 6
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    15 / 166 (9.04%)
         occurrences causally related to treatment / all
    0 / 15
         deaths causally related to treatment / all
    0 / 7
    Acute respiratory failure
         subjects affected / exposed
    4 / 166 (2.41%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    7 / 166 (4.22%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    19 / 166 (11.45%)
         occurrences causally related to treatment / all
    0 / 21
         deaths causally related to treatment / all
    0 / 4
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Transfusion-related acute lung injury
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weaning failure
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    6 / 166 (3.61%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    Cardiovascular insufficiency
         subjects affected / exposed
    6 / 166 (3.61%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    Myocardial infarction
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular failure
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Quadriparesis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acinetobacter sepsis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia acinetobacter
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 166 (1.81%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    4 / 166 (2.41%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Safety Analysis Set (SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    134 / 166 (80.72%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    16 / 166 (9.64%)
         occurrences all number
    16
    Aspartate aminotransferase increased
         subjects affected / exposed
    13 / 166 (7.83%)
         occurrences all number
    15
    Electrocardiogram QT prolonged
         subjects affected / exposed
    37 / 166 (22.29%)
         occurrences all number
    38
    Fibrin D dimer increased
         subjects affected / exposed
    22 / 166 (13.25%)
         occurrences all number
    22
    Lymphocyte count decreased
         subjects affected / exposed
    17 / 166 (10.24%)
         occurrences all number
    19
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 166 (5.42%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    25 / 166 (15.06%)
         occurrences all number
    27
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    10 / 166 (6.02%)
         occurrences all number
    10

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2020
    The original protocol (Version 1.0) dated 06-JUL-2020 was amended once. An amended protocol (Version 2.0, dated 10-NOV-2020) was instituted after the first subject was enrolled.

    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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