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    Clinical Trial Results:
    Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function

    Summary
    EudraCT number
    		 2020-001870-32
    Trial protocol
    		 DE   HU   DK   NL   ES  
    Global end of trial date
    24 Dec 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Jul 2022
    First version publication date
    01 Dec 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CDFV890D12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04382053
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    24 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 May 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
    Argentina: 3
    Country: Number of subjects enrolled
    Brazil: 13
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    India: 12
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Peru: 6
    Country: Number of subjects enrolled
    Russian Federation: 54
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Spain: 10
    Worldwide total number of subjects
    143
    EEA total number of subjects
    42
    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)
    89
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 30 sites in 12 countries.

    Pre-assignment
    Screening details
    		 Participants underwent a Screening period of up to 24 hours comprised of a Screening and a Baseline assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DFV890 + SoC
    Arm description
    		 DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DFV890
    Investigational medicinal product code
    DFV890
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.

    Arm title
    		 Standard of Care (SoC)
    Arm description
    		 SoC was used as an active comparator arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Solution for infusion, Tablet
    Routes of administration
    Intravenous use, Oral use, Inhalation use
    Dosage and administration details
    SoC was used as an active comparator arm. SoC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents

    Number of subjects in period 1
    		DFV890 + SoC Standard of Care (SoC)
    Started
    71
    72
    Safety analysis set
    70
    72
    PD analysis set
    62
    68
    Completed
    62
    59
    Not completed
    9
    13
         Adverse event, serious fatal
    6
    8
         Consent withdrawn by subject
    2
    1
         Protocol Deviation
    1
    2
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DFV890 + SoC
    Reporting group description
    		 DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.

    Reporting group title
    Standard of Care (SoC)
    Reporting group description
    		 SoC was used as an active comparator arm.

    Reporting group values
    		 DFV890 + SoC Standard of Care (SoC) Total
    Number of subjects
    		 71 72 143
    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)
    		 43 46 89
        From 65-84 years
    		 28 26 54
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.0 ( 13.31 ) 61.5 ( 10.38 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 22 24 46
        Male
    		 49 48 97
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 6 5 11
        Asian
    		 7 7 14
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 3 6
        White
    		 55 57 112
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    DFV890 + SoC
    Reporting group description
    		 DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.

    Reporting group title
    Standard of Care (SoC)
    Reporting group description
    		 SoC was used as an active comparator arm.

    Primary: APACHE II severity of disease score on Day 15 or on the day of discharge (whichever is earlier)

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    End point title
    		 APACHE II severity of disease score on Day 15 or on the day of discharge (whichever is earlier)
    End point description
    The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points. APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment.
    End point type
    Primary
    End point timeframe
    up to Day 15
    End point values
    		 DFV890 + SoC Standard of Care (SoC)
    Number of subjects analysed
    70
    72
    Units: Score on a scale
        least squares mean (standard error)
    8.7 ( 1.06 )
    8.6 ( 1.05 )
    Statistical analysis title
    		 Superiority analysis
    Comparison groups
    DFV890 + SoC v Standard of Care (SoC)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.467
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.297

    Secondary: Serum C-reactive protein (CRP) levels

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    End point title
    		 Serum C-reactive protein (CRP) levels
    End point description
    C-reactive protein (CRP) is a blood test marker for inflammation in the body. It was analyzed on a log-scale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate.
    End point type
    Secondary
    End point timeframe
    Days 2, 4, 6, 8, 10, 12, 14 and 15
    End point values
    		 DFV890 + SoC Standard of Care (SoC)
    Number of subjects analysed
    62
    68
    Units: Milligram / Liter
    geometric mean (standard error)
        Day 2 n= 60, 66
    31.4 ( 1.14 )
    46.6 ( 1.13 )
        Day 4 n= 57, 61
    22.2 ( 1.19 )
    26.5 ( 1.18 )
        Day 6 n= 52, 60
    11.5 ( 1.2 )
    15.1 ( 1.19 )
        Day 8 n= 50, 55
    7.7 ( 1.25 )
    10.9 ( 1.24 )
        Day 10 n= 41, 40
    7.0 ( 1.27 )
    8.0 ( 1.27 )
        Day 12 n= 38, 28
    7.5 ( 1.30 )
    7.1 ( 1.31 )
        Day 14 n= 34, 26
    8.1 ( 1.31 )
    6.3 ( 1.31 )
        Day 15 / end of study n= 49, 51
    6.9 ( 1.27 )
    8.2 ( 1.26 )
    Statistical analysis title
    		 Superiority Analysis
    Comparison groups
    DFV890 + SoC v Standard of Care (SoC)
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.237
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Clinical status over time

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    End point title
    		 Clinical status over time
    End point description
    Clinical status was measured with World Health Organization (WHO) 9-point ordinal scale. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
    End point type
    Secondary
    End point timeframe
    Baseline, days 2, 4, 6, 8, 10, 12, 14, 15, 17, 19, 21, 23, 25, 27 and 29
    End point values
    		 DFV890 + SoC Standard of Care (SoC)
    Number of subjects analysed
    70
    72
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.3 ( 0.49 )
    4.3 ( 0.44 )
        Day 2
    4.3 ( 0.58 )
    4.3 ( 0.80 )
        Day 4
    4.3 ( 0.83 )
    4.3 ( 0.95 )
        Day 6
    3.9 ( 1.11 )
    4.2 ( 1.13 )
        Day 8
    3.8 ( 1.31 )
    3.8 ( 1.50 )
        Day 10
    3.6 ( 1.48 )
    3.6 ( 1.88 )
        Day 12
    3.4 ( 1.66 )
    3.3 ( 1.98 )
        Day 14
    3.3 ( 1.75 )
    3.1 ( 2.03 )
        Day 15
    2.8 ( 2.02 )
    2.6 ( 2.24 )
        Day 17
    2.7 ( 2.01 )
    2.5 ( 2.22 )
        Day 19
    2.6 ( 2.01 )
    2.5 ( 2.27 )
        Day 21
    2.6 ( 2.01 )
    2.5 ( 2.33 )
        Day 23
    2.6 ( 2.03 )
    2.4 ( 2.31 )
        Day 25
    2.6 ( 2.07 )
    2.4 ( 2.31 )
        Dy 27
    2.6 ( 2.10 )
    2.4 ( 2.31 )
        Day 29
    1.9 ( 2.34 )
    1.9 ( 2.57 )
    No statistical analyses for this end point

    Secondary: Number of participants not requiring mechanical ventilation for survival

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    End point title
    		 Number of participants not requiring mechanical ventilation for survival
    End point description
    Number of participants not requiring mechanical ventilation for survival until Day 15 and Day 29: defined by WHO 9-point ordinal scale score of < 6 points at all time points assessments. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
    End point type
    Secondary
    End point timeframe
    Until Day 15 (Assessment on Days 2, 4, 6, 8, 10, 12, 14 and 15) and until Day 29 (Assessments on Days 17, 19, 21, 23, 25, 27 and 29)
    End point values
    		 DFV890 + SoC Standard of Care (SoC)
    Number of subjects analysed
    70
    72
    Units: Participants
        Until Day 15
    60
    59
        Until Day 29
    60
    58
    No statistical analyses for this end point

    Secondary: Number of participants with at least one-point improvement from baseline in clinical status

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    End point title
    		 Number of participants with at least one-point improvement from baseline in clinical status
    End point description
    Number of participants with at least one-point improvement from baseline in clinical status, which was measured with WHO 9-point ordinal scale. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15 and Day 29
    End point values
    		 DFV890 + SoC Standard of Care (SoC)
    Number of subjects analysed
    70
    72
    Units: Participants
        Day 15
    59
    53
        Day 29
    61
    60
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    DFV890 + SoC
    Reporting group description
    		 DFV890 + SoC

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Standard of Care
    Reporting group description
    		 SoC

    Serious adverse events
    		 DFV890 + SoC Total Standard of Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 70 (22.86%)
    27 / 142 (19.01%)
    11 / 72 (15.28%)
         number of deaths (all causes)
    8
    16
    8
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 142 (1.41%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Polyneuropathy
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 142 (1.41%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 142 (1.41%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 70 (5.71%)
    8 / 142 (5.63%)
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    Pulmonary embolism
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 142 (0.70%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 70 (2.86%)
    4 / 142 (2.82%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 142 (0.70%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 70 (1.43%)
    3 / 142 (2.11%)
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 142 (1.41%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DFV890 + SoC Total Standard of Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 70 (17.14%)
    18 / 142 (12.68%)
    6 / 72 (8.33%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 70 (7.14%)
    10 / 142 (7.04%)
    5 / 72 (6.94%)
         occurrences all number
    5
    10
    5
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    4 / 70 (5.71%)
    6 / 142 (4.23%)
    2 / 72 (2.78%)
         occurrences all number
    4
    6
    2
    Diabetes mellitus
         subjects affected / exposed
    4 / 70 (5.71%)
    4 / 142 (2.82%)
    0 / 72 (0.00%)
         occurrences all number
    4
    4
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2020
    The primary purpose of this protocol amendment was to address comments raised by the Health Authorities and Ethics Committees during their review of the original protocol.

    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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