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    Clinical Trial Results:
    A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

    Summary
    EudraCT number
    		 2020-003632-25
    Trial protocol
    		 DE   FR   CZ   PL   IT   ES   IE  
    Global end of trial date
    21 Nov 2023

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jun 2024
    First version publication date
    06 Jun 2024
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    206713
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04719832
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002836-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus placebo in participants with severe uncontrolled asthma with an eosinophilic phenotype on top of existing asthma therapy
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Mar 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
    Czechia: 34
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Ireland: 3
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    United States: 49
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    China: 59
    Country: Number of subjects enrolled
    Russian Federation: 21
    Worldwide total number of subjects
    382
    EEA total number of subjects
    232
    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)
    8
    Adults (18-64 years)
    276
    From 65 to 84 years
    98
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of 395 participants randomized, 382 participants received at least one dose of study intervention and included in the full analysis set population. Eleven participants were excluded due to concerns about data integrity and GCP violations; and 2 participants were randomized in error but did not receive any study drug.

    Pre-assignment
    Screening details
    		 In this study, out of 622 participants enrolled, 395 participants were randomized the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received subcutaneous (SC) injection of matching placebo once every 26 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching Placebo once every 26 weeks

    Arm title
    		 GSK3511294
    Arm description
    		 Participants received a SC injection of GSK3511294 100 milligrams (mg) once every 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3511294
    Investigational medicinal product code
    Other name
    Depemokimab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 milligram (mg) once every 26 weeks

    Number of subjects in period 1
    		Placebo GSK3511294
    Started
    132
    250
    Completed
    122
    237
    Not completed
    10
    13
         Consent withdrawn by subject
    5
    5
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    -
         Pregnancy
    1
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) injection of matching placebo once every 26 weeks.

    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a SC injection of GSK3511294 100 milligrams (mg) once every 26 weeks.

    Reporting group values
    		 Placebo GSK3511294 Total
    Number of subjects
    		 132 250 382
    Age categorical
    Units: Participants
        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)
    		 5 3 8
        Adults (18-64 years)
    		 91 185 276
        From 65-84 years
    		 36 62 98
        85 years and over
    		 0 0 0
    Sex: Female, Male
    Units: Participants
        Female
    		 79 144 223
        Male
    		 53 106 159
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    		 20 38 58
        BLACK OR AFRICAN AMERICAN
    		 3 5 8
        WHITE
    		 109 207 316
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 53.6 ( 14.91 ) 54.1 ( 13.82 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) injection of matching placebo once every 26 weeks.

    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a SC injection of GSK3511294 100 milligrams (mg) once every 26 weeks.

    Primary: Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks

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    End point title
    		 Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
    End point description
    Clinically significant exacerbations of asthma were defined by worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visit. Exacerbations occurring from the start of randomized study treatment up to the Week 52 visit, including exacerbations reported after early discontinuation from study treatment by participants who remained in the study, were included in the analysis. Annualized rate of exacerbations was analyzed using a generalized linear model assuming a negative binomial distribution. The analysis was performed on the Full Analysis Set which comprised of all randomized participants who received at least one dose of study intervention excluding participants from one study site due to concerns about data integrity and GCP violation.
    End point type
    Primary
    End point timeframe
    From first dose of study treatment up to Week 52
    End point values
    		 Placebo GSK3511294
    Number of subjects analysed
    132
    249
    Units: Exacerbation per participant per year
        number (confidence interval 95%)
    1.11 (0.86 to 1.43)
    0.46 (0.37 to 0.58)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.
    Comparison groups
    Placebo v GSK3511294
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Negative binomial distribution
    Parameter type
    		 Rate Ratio
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.59
    Notes
    [1] - Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline ICS dose (medium, high), geographical region, baseline percent predicted FEV1, and offset of log (total time in the study in years)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected were collected from the start of the study intervention till follow up week 56 .
    Adverse event reporting additional description
    All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all participants who received at least 1 dose of study treatment excluding participants from one study site due to concerns about data integrity and GCP violation. AEs were reported treatment-wise.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    GSK3511294
    Reporting group description
    		 Participants received a 100 mg dose of GSK3511294 subcutaneously once every 26 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo subcutaneously once every 26 weeks

    Serious adverse events
    		 GSK3511294 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 250 (6.00%)
    22 / 132 (16.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Mass
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Genital prolapse
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         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
    Pneumothorax
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    3 / 250 (1.20%)
    5 / 132 (3.79%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice cholestatic
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 250 (0.40%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 250 (0.40%)
    3 / 132 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 250 (0.00%)
    2 / 132 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (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
    Hypoglycaemia
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 132 (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: 3%
    Non-serious adverse events
    		 GSK3511294 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    145 / 250 (58.00%)
    78 / 132 (59.09%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 250 (3.60%)
    7 / 132 (5.30%)
         occurrences all number
    10
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 250 (4.80%)
    10 / 132 (7.58%)
         occurrences all number
    17
    13
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 250 (0.80%)
    4 / 132 (3.03%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 250 (3.60%)
    6 / 132 (4.55%)
         occurrences all number
    23
    7
    Rhinitis allergic
         subjects affected / exposed
    11 / 250 (4.40%)
    4 / 132 (3.03%)
         occurrences all number
    15
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 250 (2.40%)
    7 / 132 (5.30%)
         occurrences all number
    6
    11
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    9 / 250 (3.60%)
    4 / 132 (3.03%)
         occurrences all number
    9
    4
    Influenza
         subjects affected / exposed
    19 / 250 (7.60%)
    2 / 132 (1.52%)
         occurrences all number
    21
    2
    Nasopharyngitis
         subjects affected / exposed
    29 / 250 (11.60%)
    25 / 132 (18.94%)
         occurrences all number
    37
    32
    Pharyngitis
         subjects affected / exposed
    8 / 250 (3.20%)
    2 / 132 (1.52%)
         occurrences all number
    8
    2
    Respiratory tract infection
         subjects affected / exposed
    8 / 250 (3.20%)
    6 / 132 (4.55%)
         occurrences all number
    9
    11
    Rhinitis
         subjects affected / exposed
    15 / 250 (6.00%)
    10 / 132 (7.58%)
         occurrences all number
    17
    16
    Sinusitis
         subjects affected / exposed
    11 / 250 (4.40%)
    6 / 132 (4.55%)
         occurrences all number
    14
    6
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 250 (10.00%)
    14 / 132 (10.61%)
         occurrences all number
    39
    22
    Lower respiratory tract infection
         subjects affected / exposed
    10 / 250 (4.00%)
    5 / 132 (3.79%)
         occurrences all number
    10
    7
    COVID-19
         subjects affected / exposed
    51 / 250 (20.40%)
    27 / 132 (20.45%)
         occurrences all number
    51
    30
    Bronchitis
         subjects affected / exposed
    12 / 250 (4.80%)
    5 / 132 (3.79%)
         occurrences all number
    18
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2021
    Amendment 1
    08 Apr 2022
    Amendment 2

    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.
    Data has not been disclosed for secondary endpoints for this study. We will disclose data for all pre-specified secondary endpoints by 21-Nov-2024.
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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
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