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    Clinical Trial Results:
    Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safetyof two doses of WJ-MSC in patients with acute respiratory distress syndrome secondary to infection by COVID-19

    Summary
    EudraCT number
    		 2020-001505-22
    Trial protocol
    		 ES  
    Global end of trial date
    20 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2023
    First version publication date
    12 Jul 2023
    Other versions
    Summary report(s)
    		 COVIDMES Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    BST-COVID-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Banc de Sang i Teixits
    Sponsor organisation address
    Passeig Taulat, 116, Barcelona, Spain, 08005
    Public contact
    Banc de Sang i Teixits, Banc de Sang i Teixits, 34 935573500 (6707), rucoll@bst.cat
    Scientific contact
    Banc de Sang i Teixits, Banc de Sang i Teixits, 34 935573500 (6707), rucoll@bst.cat
    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
    20 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    All-cause mortality at day 28
    Protection of trial subjects
    Depending on the patient's condition, obtaining consent was follows: - In conscious hospitalized patients, oral consent was obtained in the presence of a family witness (via telephone) or, if unavailable, an impartial witness (unrelated to the research team). -In unconscious hospitalized patients, informed consent was obtained via telephone from a family member. The following document should be completed and signed in both circumstances: "CONFIRMATION OF ORAL INFORMED CONSENT FOR COVID-19 EMERGENCY". This document served as proof that oral consent had been obtained. It was acceptable for the Principal Investigator or a research team member to explain the study remotely (via telephone, or video conference) in the presence of an impartial witness. Additionally, it had to be documented in the patient's medical record that temporary oral consent had been obtained. When circumstances permit, patients had to sign the written consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    17
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients admitted to the Intensive Care Unit and affected with SARS-CoV-2 (positive PCR)

    Pre-assignment
    Screening details
    		 SARS-CoV-2 (positive PCR)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 WJ-MSC
    Arm description
    		 Patients assigned to Wharton-Jelly mesenchymal stromal cells on D1 and D3
    Arm type
    		 Experimental

    Investigational medicinal product name
    WJ-MSC
    Investigational medicinal product code
    Other name
    XCEl-UMC-BETA
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1E6cells/Kg administered endovenously

    Arm title
    		 Placebo
    Arm description
    		 Patients assigned to placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo for endovenous administration

    Number of subjects in period 1
    		WJ-MSC Placebo
    Started
    14
    11
    Completed
    14
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    WJ-MSC
    Reporting group description
    		 Patients assigned to Wharton-Jelly mesenchymal stromal cells on D1 and D3

    Reporting group title
    Placebo
    Reporting group description
    		 Patients assigned to placebo

    Reporting group values
    		 WJ-MSC Placebo Total
    Number of subjects
    		 14 11 25
    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)
    		 14 11 25
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.93 ( 8.54 ) 57.55 ( 11.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 3 8
        Male
    		 9 8 17
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized population that has received at least one treatment dose and has the primary endpoint in the baseline evaluation and an evaluation after treatment. This set will be used in efficacy analysis for intention-to-treat (ITT) analysis.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    25
    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)
    25
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    WJ-MSC
    Reporting group description
    		 Patients assigned to Wharton-Jelly mesenchymal stromal cells on D1 and D3

    Reporting group title
    Placebo
    Reporting group description
    		 Patients assigned to placebo

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Randomized population that has received at least one treatment dose and has the primary endpoint in the baseline evaluation and an evaluation after treatment. This set will be used in efficacy analysis for intention-to-treat (ITT) analysis.

    Primary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Primary
    End point timeframe
    28days
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    14
    11
    Units: n
    0
    2
    Statistical analysis title
    		 Mortality at day 28
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1833
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Need of mechanical ventilation

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    End point title
    		 Need of mechanical ventilation
    End point description
    Patients requiring invasive mechanical ventilation from the start of treatment to day +28, by treatment group
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    14
    11
    Units: n
    10
    5
    Statistical analysis title
    		 Mechanical ventilation
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2406
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Duration of mechanical ventilation

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    End point title
    		 Duration of mechanical ventilation
    End point description
    Average number of days on mechanical ventilation, per treatment group
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    14
    11
    Units: days
    10
    5
    Statistical analysis title
    		 Days on mechanical ventilation
    Statistical analysis description
    Average number of days on mechanical ventilation
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0842
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Days free of mechanical ventilation

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    End point title
    		 Days free of mechanical ventilation
    End point description
    Days after treatment in which the patient remained alive and free of invasive mechanical ventilation, until day +28, by treatment group
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    14
    11
    Units: days
    10
    5
    Statistical analysis title
    		 Days free of mechanical ventilation
    Statistical analysis description
    Days after treatment in which the patient remained alive and free of invasive mechanical ventilation, until day +28, by treatment group
    Comparison groups
    Placebo v WJ-MSC
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Evaluation of the SOFA index

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    End point title
    		 Evaluation of the SOFA index
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    7
    7
    Units: units
        arithmetic mean (standard deviation)
    -1.57 ( 3.05 )
    -2.57 ( 1.51 )
    Statistical analysis title
    		 SOFA index
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8893
    Method
    		 ANOVA
    Confidence interval

    Secondary: Assessment of the APACHE II score

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    End point title
    		 Assessment of the APACHE II score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    7
    7
    Units: score
        arithmetic mean (standard deviation)
    -2.29 ( 5.41 )
    -5.29 ( 4.50 )
    Statistical analysis title
    		 APACHE II score
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3552
    Method
    		 ANOVA
    Confidence interval

    Secondary: Immune response (leukocyte count)

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    End point title
    		 Immune response (leukocyte count)
    End point description
    Variation in the leukocyte count after the start of treatment with respect to the baseline value, by treatment group
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    13
    9
    Units: x109/L
        arithmetic mean (standard deviation)
    -2.11 ( 5.24 )
    -2.48 ( 2.49 )
    Statistical analysis title
    		 Immune response (leukocyte)
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5908
    Method
    		 ANOVA
    Confidence interval

    Secondary: Immune response (neutrophil count)

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    End point title
    		 Immune response (neutrophil count)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    13
    9
    Units: x109/L
        arithmetic mean (standard deviation)
    -3.18 ( 4.69 )
    -3.99 ( 2.86 )
    Statistical analysis title
    		 Immune response (neutrophil count)
    Statistical analysis description
    Variation in the neutrophil count on day 28 post-initiation of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6127
    Method
    		 ANOVA
    Confidence interval

    Secondary: Immune response (percentage of neutrophils)

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    End point title
    		 Immune response (percentage of neutrophils)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    13
    9
    Units: %
        arithmetic mean (standard deviation)
    -20.75 ( 10.55 )
    -22.41 ( 12.98 )
    Statistical analysis title
    		 Immune response (percentage of neutrophils)
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4035
    Method
    		 ANOVA
    Confidence interval

    Secondary: Marker of disease progression Ferritin

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    End point title
    		 Marker of disease progression Ferritin
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    10
    5
    Units: ng/mL
        arithmetic mean (standard deviation)
    -1531.34 ( 2181.85 )
    -1461.06 ( 750.97 )
    Statistical analysis title
    		 • Markers of disease progression Ferritin
    Statistical analysis description
    Variation in the value of Ferritin on day 28 after the start of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0
    Method
    		 ANOVA
    Confidence interval

    Secondary: Marker of disease progression LDH

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    End point title
    		 Marker of disease progression LDH
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    11
    6
    Units: U/L
        arithmetic mean (standard deviation)
    -198.95 ( 170.00 )
    -242.60 ( 98.02 )
    Statistical analysis title
    		 Marker of disease progression LDH
    Statistical analysis description
    Variation in the LDH value on day 28 after the start of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4875
    Method
    		 ANOVA
    Confidence interval

    Secondary: Marker of disease progression RT-PCR

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    End point title
    		 Marker of disease progression RT-PCR
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    12
    9
    Units: mg/dL
        arithmetic mean (standard deviation)
    -19.58 ( 27.52 )
    -35.15 ( 36.94 )
    Statistical analysis title
    		 Marker of disease progression RT-PCR
    Statistical analysis description
    Variation in the RT-PCR value on day 28 after the start of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.614
    Method
    		 ANOVA
    Confidence interval

    Secondary: Marker of disease progression D-dimer

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    End point title
    		 Marker of disease progression D-dimer
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    10
    7
    Units: ug/L
        arithmetic mean (standard deviation)
    517.10 ( 1697.57 )
    306.29 ( 1248.83 )
    Statistical analysis title
    		 Marker of disease progression D-dimer
    Statistical analysis description
    Variation in the D-dimer value on day 28 after the start of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8554
    Method
    		 ANOVA
    Confidence interval

    Secondary: Marker of disease progression procalcitonin

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    End point title
    		 Marker of disease progression procalcitonin
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 WJ-MSC Placebo
    Number of subjects analysed
    7
    7
    Units: ng/mL
        arithmetic mean (standard deviation)
    -1.99 ( 5.19 )
    -0.37 ( 0.92 )
    Statistical analysis title
    		 Marker of disease progression Procalcitonin
    Statistical analysis description
    Variation in the value of procalcitonin on day 28 after the start of treatment with respect to the baseline value, by treatment group
    Comparison groups
    WJ-MSC v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.494
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signature of the informed consent to the last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    WJ-MSC
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo WJ-MSC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    4 / 14 (28.57%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 14 (21.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute renal failure
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo WJ-MSC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    8 / 14 (57.14%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Hypoxia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pneumomediastinum
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Delirium
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 11 (0.00%)
    4 / 14 (28.57%)
         occurrences all number
    0
    4
    Systolic dysfunction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Intensive care unit acquired weakness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Anaemia macrocytic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin toxicity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    acute renal failure
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pseudomonas bronchitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Enterococcal infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Bacteraemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Medical device site infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Tracheobronchitis bacterial
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gout
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2020
    New centers and prolongation of recruitment period

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Jun 2021
    Due to difficulties to recruit patients, it was decided to close the study
    -

    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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