Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

    Summary
    EudraCT number
    		 2021-001194-24
    Trial protocol
    		 BG  
    Global end of trial date
    06 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2023
    First version publication date
    21 Jun 2023
    Other versions
    Summary report(s)
    		 V3011902 Synopsis

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V3011902
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04842747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Veru Inc.
    Sponsor organisation address
    2916 North Miami Ave, Miami, United States, 33127
    Public contact
    Veru Clinical Trials Rodriguez, Veru Inc., 001 800-606-9382, veruclinicaltrials@verupharma.com
    Scientific contact
    Veru Clinical Trials Barnette, Veru Inc., 001 800-606-9382, veruclinicaltrials@verupharma.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
    21 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of VERU-111 in the treatment of SARS-CoV-2 infection by assessing its effect on the proportion of subjects that die on study (up to Day 60).
    Protection of trial subjects
    Each subject was consented prior to participating in the trial according to ICH GCP guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 May 2021
    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
    Bulgaria: 48
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Brazil: 78
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Mexico: 3
    Country: Number of subjects enrolled
    United States: 71
    Worldwide total number of subjects
    204
    EEA total number of subjects
    48
    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)
    106
    From 65 to 84 years
    96
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 244 patients were recruited at 37 sites across 6 countries in accordance with ICH/GCP guidelines.

    Pre-assignment
    Screening details
    		 All patients were screened within three days of Day 1 / randomization. Total of 244 patients were screened. 40 patients screen failed.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All study team members with the exception of an unblinded statistician and the IDMC committee members were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 9mg of VERU-111 Oral daily
    Arm description
    		 Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VERU-111
    Investigational medicinal product code
    Other name
    Sabizabulin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects in the VERU-111 treatment groups will receive oral daily VERU-111 9 mg for 21 days or until released from hospital, whichever comes first.

    Arm title
    		 Placebo Capsule once daily
    Arm description
    		 Subjects in the Placebo treatment group received standard of care, plus a placebo capsule for 21 days or until released from hospital.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects in the Placebo treatment group received one placebo capsule for 21 days or until released from hospital, whichever came first.

    Number of subjects in period 1
    		9mg of VERU-111 Oral daily Placebo Capsule once daily
    Started
    134
    70
    Completed
    125
    66
    Not completed
    9
    4
         Consent withdrawn by subject
    6
    2
         Physician decision
    1
    -
         PT refused all care decision made to withdraw PT
    1
    -
         Lost to follow-up
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    9mg of VERU-111 Oral daily
    Reporting group description
    		 Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.

    Reporting group title
    Placebo Capsule once daily
    Reporting group description
    		 Subjects in the Placebo treatment group received standard of care, plus a placebo capsule for 21 days or until released from hospital.

    Reporting group values
    		 9mg of VERU-111 Oral daily Placebo Capsule once daily Total
    Number of subjects
    		 134 70 204
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.3 ( 14.14 ) 62.7 ( 13.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 26 70
        Male
    		 90 44 134
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Set: All randomized patients who received at least 1 dose of study drug (sabizabulin or placebo).

    Subject analysis set title
    ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients

    Subject analysis sets values
    		 Safety Set ITT Set
    Number of subjects
    199
    204
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.6 ( 14.08 )
    61.8 ( 14.04 )
    Gender categorical
    Units: Subjects
        Female
    67
    70
        Male
    132
    134

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    9mg of VERU-111 Oral daily
    Reporting group description
    		 Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.

    Reporting group title
    Placebo Capsule once daily
    Reporting group description
    		 Subjects in the Placebo treatment group received standard of care, plus a placebo capsule for 21 days or until released from hospital.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Set: All randomized patients who received at least 1 dose of study drug (sabizabulin or placebo).

    Subject analysis set title
    ITT Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients

    Primary: Efficacy of sabizabulin in the treatment of SARS-CoV-2 infection by assessing its effect on the proportion of patients who died on study.

    		 Close Top of page
    End point title
    		 Efficacy of sabizabulin in the treatment of SARS-CoV-2 infection by assessing its effect on the proportion of patients who died on study.
    End point description
    The primary endpoint for the study was the proportion of patients who died on study (up to Day 60). Responders were patients who were alive at Day 60. The number and percentage of deaths were summarized by treatment group. The primary analysis was performed on the ITT Set, regardless of rescue medication use, protocol violations or study drug discontinuation, consistent with the treatment policy strategy.
    End point type
    Primary
    End point timeframe
    Day 60
    End point values
    		 9mg of VERU-111 Oral daily Placebo Capsule once daily ITT Set
    Number of subjects analysed
    134
    70
    204
    Units: 52
        number (confidence interval 95%)
    8.14 (3.23 to 14.75)
    2.79 (1.16 to 5.36)
    2.79 (1.37 to 5.6)
    Statistical analysis title
    		 Efficacy Analyses
    Statistical analysis description
    All statistical tests will be performed using a two-tailed 5% overall significance level, unless otherwise stated. All comparisons between treatments will be reported with 95% confidence intervals for the difference.
    Comparison groups
    9mg of VERU-111 Oral daily v Placebo Capsule once daily
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.0452 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [1] - 2 sided P Value. 1-sided P-value ≤0.0226 in favor of sabizabulin (final analysis).

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    First drug administration thru Day 60.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    70 / 199 (35.18%)
         number of deaths (all causes)
    48
         number of deaths resulting from adverse events
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Endotracheal intubation complication
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Arterial thrombosis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shock
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 2
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary valve incompetence
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Coma
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Polyneuropathy
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure like phenomena
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stroke in evolution
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Procedural failure
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Mydriasis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    8 / 199 (4.02%)
         occurrences causally related to treatment / all
    2 / 8
         deaths causally related to treatment / all
    2 / 5
    Dyspnoea
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    5 / 199 (2.51%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    Laryngeal stenosis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    7 / 199 (3.52%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    6 / 199 (3.02%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiration abnormal
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    27 / 199 (13.57%)
         occurrences causally related to treatment / all
    2 / 28
         deaths causally related to treatment / all
    2 / 9
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    12 / 199 (6.03%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal impairment
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acinetobacter infection
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Burkholderia cepacia complex infection
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    COVID-19
         subjects affected / exposed
    7 / 199 (3.52%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 5
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Endocarditis staphylococcal
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 199 (4.02%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 4
    Pneumonia acinetobacter
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    6 / 199 (3.02%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    7 / 199 (3.52%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    Severe acute respiratory syndrome
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Urinary tract infection fungal
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    136 / 199 (68.34%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    13 / 199 (6.53%)
         occurrences all number
    17
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    11 / 199 (5.53%)
         occurrences all number
    11
    Bradycardia
         subjects affected / exposed
    11 / 199 (5.53%)
         occurrences all number
    12
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    10 / 199 (5.03%)
         occurrences all number
    10
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    15 / 199 (7.54%)
         occurrences all number
    19
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    10 / 199 (5.03%)
         occurrences all number
    10
    Hypoxia
         subjects affected / exposed
    7 / 199 (3.52%)
         occurrences all number
    7
    Pneumothorax
         subjects affected / exposed
    8 / 199 (4.02%)
         occurrences all number
    8
    Respiratory failure
         subjects affected / exposed
    27 / 199 (13.57%)
         occurrences all number
    28
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    8 / 199 (4.02%)
         occurrences all number
    9
    Delirium
         subjects affected / exposed
    9 / 199 (4.52%)
         occurrences all number
    9
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    19 / 199 (9.55%)
         occurrences all number
    19
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    17 / 199 (8.54%)
         occurrences all number
    24
    Septic shock
         subjects affected / exposed
    7 / 199 (3.52%)
         occurrences all number
    7
    Urinary tract infection
         subjects affected / exposed
    9 / 199 (4.52%)
         occurrences all number
    9
    Metabolism and nutrition disorders
    Hyperkalemia
         subjects affected / exposed
    12 / 199 (6.03%)
         occurrences all number
    13
    Hypernatremia
         subjects affected / exposed
    10 / 199 (5.03%)
         occurrences all number
    10
    Hypokalemia
         subjects affected / exposed
    11 / 199 (5.53%)
         occurrences all number
    14

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 10 01:08:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA