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    Clinical Trial Results:
    A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19

    Summary
    EudraCT number
    		 2020-003278-37
    Trial protocol
    		 DK   GB   SE   PL   GR   IT  
    Global end of trial date
    14 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2023
    First version publication date
    06 Dec 2023
    Other versions
    Summary report(s)
    		 Efficacy & Safety of Ensovibep (MP0420)
    Efficacy & safety of sotrovimab, BRII-196/BRII-198
    Tixa-cilga for COVID-19
    Neutralizing MAb LY-CoV555
    Results from final ACTIV-3 trial (Pfizer protease inhibitor)

    Trial information

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    Trial identification
    Sponsor protocol code
    INSIGHT-014-ACTIV-3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04501978
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regents of the University of Minnesota
    Sponsor organisation address
    Office of the Vice President for Research, 420 Johnston Hall, 101 Pleasant St. SE, Minneapolis, United States, MN 55455
    Public contact
    Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, +45 3545 5757, jens.lundgren@regionh.dk
    Scientific contact
    Jens Lundgren, CHIP - Rigshospitalet, University of Copenhagen, +45 3545 5757, jens.lundgren@regionh.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
    14 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this protocol is to determine whether investigational agents, initially focusing on those that are aimed at enhancing the host immune response to SARS-CoV-2 infection are safe and superior to control (e.g., placebo) when given with SOC for the primary endpoint of time to sustained recovery evaluated up to 90 days after randomization. SOC may be modified (updated based on data from this or other trials) during the course of evaluating different investigational agents with this master protocol. Over the entire course of ACTIV-3/TICO, 6 different agents were evaluated. Detailed results are presented here for the first agent; results for the remaining 5 agents are provided in attachments to this record.
    Protection of trial subjects
    To the extent possible, blood for study purposes was taken from the same stick as that for clinical care. Participants were monitored closely during study product infusion and for several hours afterward, with regular vital signs measurement and recording of adverse events.
    Background therapy
    		 Remdesivir was provided to all study participants as standard of care (SOC) unless contraindicated for an individual patient; administered by IV infusion.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 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
    Denmark: 38
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    United States: 275
    Worldwide total number of subjects
    314
    EEA total number of subjects
    38
    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)
    181
    From 65 to 84 years
    122
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from participating hospitals between 05 August 2020 and 26 October 2020.

    Pre-assignment
    Screening details
    		 Hospitalized adults with COVID-19.

    Period 1
    Period 1 title
    1st ACTIV-3 trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Assessor, Subject
    Blinding implementation details
    Randomizer was given a treatment ID, which was sent to the pharmacy. The ID was decoded in the pharmacy. A saline placebo infusion was used. The infusion bag was covered with a colored sleeve to mask the slight different in color between the active product and placebo

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY3819253 plus SOC
    Arm description
    		 LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as standard of care (SOC) unless contraindicated for an individual patient; administered by IV infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3819253
    Investigational medicinal product code
    Other name
    LY-CoV555, bamlanivimab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    LY3819253 was administered as a single dose of 7000 mg (200 mL)

    Arm title
    		 Placebo plus SOC
    Arm description
    		 Normal saline was administered as a single dose of 200 mL by IV infusion. Remdesivir is provided to all study participants unless contraindicated for an individual patient; administered by IV infusion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Normal saline was administered as a single dose of 200 mL.

    Number of subjects in period 1
    		LY3819253 plus SOC Placebo plus SOC
    Started
    163
    151
    Completed
    163
    151

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY3819253 plus SOC
    Reporting group description
    		 LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as standard of care (SOC) unless contraindicated for an individual patient; administered by IV infusion

    Reporting group title
    Placebo plus SOC
    Reporting group description
    		 Normal saline was administered as a single dose of 200 mL by IV infusion. Remdesivir is provided to all study participants unless contraindicated for an individual patient; administered by IV infusion.

    Reporting group values
    		 LY3819253 plus SOC Placebo plus SOC Total
    Number of subjects
    		 163 151 314
    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
    age in years
    Units: years
        arithmetic mean (standard deviation)
    		 60.4 ± 14.2 58.9 ± 16.3 -
    Gender categorical
    Gender at birth
    Units: Subjects
        Female
    		 66 71 137
        Male
    		 97 80 177
    Race/ethnicity
    Participants were asked to identify their race/ethnicity in a single question. Participants could choose multiple answers.
    Units: Subjects
        American Indian/Alaska Native
    		 3 0 3
        Asian
    		 6 7 13
        Native Hawaiian/Pacific Islander
    		 1 1 2
        Black/African American
    		 32 34 66
        White
    		 90 88 178
        More than one race
    		 1 1 2
        Other
    		 4 4 8
        Only ethnicity (Hispanic/Latino vs. not)reported
    		 26 16 42

    End points

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    End points reporting groups
    Reporting group title
    LY3819253 plus SOC
    Reporting group description
    		 LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as standard of care (SOC) unless contraindicated for an individual patient; administered by IV infusion

    Reporting group title
    Placebo plus SOC
    Reporting group description
    		 Normal saline was administered as a single dose of 200 mL by IV infusion. Remdesivir is provided to all study participants unless contraindicated for an individual patient; administered by IV infusion.

    Primary: Ordinal Outcome on Day 5

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    End point title
    		 Ordinal Outcome on Day 5
    End point description
    Ordinal outcome with 7 mutually exclusive categories
    End point type
    Primary
    End point timeframe
    Through trial Day 5 (where Day 0 is randomization)
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: Participants
        Death
    1
    0
        Inv. vent, ECMO, circ support, new renal repl tx
    8
    5
        Non-invasive vent or high-flow O2
    25
    22
        Supplemental O2 >=4L/min or 4L/min above BL
    17
    11
        Supplemental O2 <4L/min or <4L/min above BL
    29
    31
        Limiting symptoms d/t COVID-19, no new O2
    50
    48
        No limiting symptoms d/t COVID-19
    31
    33
    Statistical analysis title
    		 Pulmonary ordinal outcome on Day 5
    Statistical analysis description
    The analysis estimates the summary odds ratio of a better outcome with active treatment than with placebo, using a proportional odds model that included the treatment group indicator
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.29

    Primary: Time to achieve sustained recovery

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    End point title
    		 Time to achieve sustained recovery
    End point description
    Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90
    End point type
    Primary
    End point timeframe
    Through Day 90
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: participants
        Achieved sustained recovery
    144
    136
    Statistical analysis title
    		 Time to sustained recovery
    Statistical analysis description
    This provides the recovery rate ratio comparing time to sustained recovery between treatment groups
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.47

    Secondary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Through Day 90 (where Day 0 is randomization)
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: participants
        Dead at Day 90
    13
    11
    Statistical analysis title
    		 Time to death
    Statistical analysis description
    Death through Day 90, hazard ratio estimated from Cox model with stratification by site pharmacy
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.84
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 2.43

    Secondary: Safety outcome through Day 5

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    End point title
    		 Safety outcome through Day 5
    End point description
    Death, SAE, Grade 3 or 4 event, organ failure, or serious infection through Day 5
    End point type
    Secondary
    End point timeframe
    Through Day 5 (where Day 0 is randomization)
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: participants
        Experienced safety outcome
    45
    28
    Statistical analysis title
    		 Day 5 composite safety outcome
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 3.29

    Secondary: Safety outcome through Day 28

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    End point title
    		 Safety outcome through Day 28
    End point description
    Death, SAE, Grade 3 or 4 event, organ failure, or serious infection through Day 28
    End point type
    Secondary
    End point timeframe
    Through Day 28 (where Day 0 is randomization)
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: participants
        Experienced safety event by Day 28
    52
    42
    Statistical analysis title
    		 Day 28 composite safety outcome
    Statistical analysis description
    Hazard ratio estimated from Cox model with stratification by site pharmacy
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.82

    Secondary: Safety outcome through Day 90

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    End point title
    		 Safety outcome through Day 90
    End point description
    Death, SAE, organ failure, or serious infections through Day 90
    End point type
    Secondary
    End point timeframe
    Through Day 90 (where Day 0 is randomization)
    End point values
    		 LY3819253 plus SOC Placebo plus SOC
    Number of subjects analysed
    163
    151
    Units: participants
        Experienced safety outcome by Day 90
    45
    41
    Statistical analysis title
    		 Day 90 composite safety outcome
    Statistical analysis description
    hazard ratio estimated from Cox model with stratification by site pharmacy
    Comparison groups
    LY3819253 plus SOC v Placebo plus SOC
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through Day 90
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    LY3819253 plus SOC
    Reporting group description
    		 LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as standard of care (SOC) unless contraindicated for an individual patient; administered by IV infusion

    Reporting group title
    Placebo plus SOC
    Reporting group description
    		 Normal saline was administered as a single dose of 200 mL by IV infusion. Remdesivir is provided to all study participants unless contraindicated for an individual patient; administered by IV infusion.

    Serious adverse events
    		 LY3819253 plus SOC Placebo plus SOC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 163 (7.98%)
    12 / 151 (7.95%)
         number of deaths (all causes)
    13
    11
         number of deaths resulting from adverse events
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         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
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 151 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cholecystitis infective
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraspinal abscess
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    		 LY3819253 plus SOC Placebo plus SOC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 163 (25.15%)
    27 / 151 (17.88%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    6 / 163 (3.68%)
    3 / 151 (1.99%)
         occurrences all number
    7
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    9 / 163 (5.52%)
    5 / 151 (3.31%)
         occurrences all number
    10
    5
    Hypothermia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 151 (0.66%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 163 (1.23%)
    2 / 151 (1.32%)
         occurrences all number
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 163 (0.00%)
    3 / 151 (1.99%)
         occurrences all number
    0
    3
    Dyspnoea
         subjects affected / exposed
    15 / 163 (9.20%)
    10 / 151 (6.62%)
         occurrences all number
    17
    10
    Epistaxis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 151 (1.32%)
         occurrences all number
    1
    2
    Pneumothorax
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    3
    0
    Respiratory distress
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 151 (0.00%)
         occurrences all number
    2
    0
    Respiratory failure
         subjects affected / exposed
    4 / 163 (2.45%)
    3 / 151 (1.99%)
         occurrences all number
    4
    3
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 151 (0.00%)
         occurrences all number
    2
    0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 151 (0.66%)
         occurrences all number
    2
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Anxiety
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Encephalopathy
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 151 (1.32%)
         occurrences all number
    1
    2
    Mental status changes
         subjects affected / exposed
    7 / 163 (4.29%)
    1 / 151 (0.66%)
         occurrences all number
    7
    1
    Panic attack
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Seizure
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Febrile neutropenia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 151 (1.32%)
         occurrences all number
    0
    2
    Pancreatitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 163 (3.07%)
    1 / 151 (0.66%)
         occurrences all number
    7
    1
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 151 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Candida infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Paraspinal abscess
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 151 (0.66%)
         occurrences all number
    1
    1
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Pseudomonas infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 151 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 151 (1.99%)
         occurrences all number
    4
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 151 (0.66%)
         occurrences all number
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 151 (0.66%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 151 (0.00%)
         occurrences all number
    1
    0

    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? Yes
    Date
    Interruption
    Restart date
    26 Oct 2020
    The DSMB halted enrollment for futility.
    -

    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/33356051
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    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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