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    Clinical Trial Results:
    A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of RV521 Against Respiratory Syncytial Virus infection in the Virus Challenge Model.

    Summary
    EudraCT number
    2017-001282-24
    Trial protocol
    GB  
    Global end of trial date
    31 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Jun 2019
    First version publication date
    19 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    REVC002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03258502
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ReViral Ltd
    Sponsor organisation address
    Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage, Hertfordshire, United Kingdom, SG1 2FX
    Public contact
    Director Clinical Operations, ReViral Ltd, +44 1438 906760,
    Scientific contact
    Chief Operating Officer, ReViral Ltd, +44 1438 906760,
    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
    12 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the antiviral activity of RV521 compared to placebo in healthy adult subjects inoculated with RSV-A Memphis 37b.
    Protection of trial subjects
    This study will be conducted in accordance with the Ethical Principles for Medical Research Involving Human Subjects outlined in the Declaration of Helsinki 19961, the principles of ICH GCP2, current regulatory requirements as detailed in the Medicines for Human Use (Clinical Trial) Regulations (SI 2004/1031)4 and all subsequent amendments, the UK Data Protection Act 19985, any other applicable laws and guidance, and any Sponsor requirements. All ethical and legal requirements will be met before the first subject is enrolled in the study. Safety of the subjects was safeguarded through safety data review and the implementation of study stopping criteria. Safety endpoint measurements included vital signs, 12-lead ECGs, physical examinations, safety laboratory blood tests (biochemistry, haematology, coagulation and cardiac enzymes) and urinalysis. Adverse events were continuously monitored throughout the study from date of consent until the last follow up assessment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    66 subjects were enrolled and 65 subjects have completed the study.

    Pre-assignment
    Screening details
    Subjects were healthy males and/or females, 18 to 45 years of age, who met the eligibility criteria outlined in the Protocol.

    Pre-assignment period milestones
    Number of subjects started
    66
    Number of subjects completed
    66

    Period 1
    Period 1 title
    Overall trial (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
    The study was conducted in a double-blind fashion, whereby subjects and clinical study site staff were blinded to the active or placebo study drug assignment. However, the subjects and clinical study site staff were aware of the dose level that was used in each cohort. As 2 dose levels are used in this study, quarantine staff were to have ensured that each subject remained in their own room without direct contact with any other subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo to match RV521 (The placebo group was split equally across the 2 dose groups such that subjects received placebo at dose level 200 mg in Cohort 1 and at 350 mg in Cohort 2).
    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
    Placebo capsules at dose level 200 mg (Cohort 1) or 350 mg (Cohort 2), 12 hours apart (± 1 hour) for 10 consecutive doses.

    Arm title
    200mg RV521
    Arm description
    200 mg of RV521 (Cohort 1)
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200mg Oral RV521 or placebo, 12 hours apart (± 1 hour) for 10 consecutive doses.

    Arm title
    350mg RV521
    Arm description
    350mg of RV521 (Cohort 2)
    Arm type
    Experimental

    Investigational medicinal product name
    RV521
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    350mg Oral RV521 or placebo, 12 hours apart (± 1 hour) for 10 consecutive doses.

    Number of subjects in period 1
    Placebo 200mg RV521 350mg RV521
    Started
    22
    22
    22
    Completed
    21
    22
    22
    Not completed
    1
    0
    0
         Adverse event, non-fatal
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo to match RV521 (The placebo group was split equally across the 2 dose groups such that subjects received placebo at dose level 200 mg in Cohort 1 and at 350 mg in Cohort 2).

    Reporting group title
    200mg RV521
    Reporting group description
    200 mg of RV521 (Cohort 1)

    Reporting group title
    350mg RV521
    Reporting group description
    350mg of RV521 (Cohort 2)

    Reporting group values
    Placebo 200mg RV521 350mg RV521 Total
    Number of subjects
    22 22 22 66
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    22 22 22 66
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.6 ± 5.29 21.7 ± 3.09 24.5 ± 5.50 -
    Gender categorical
    Units: Subjects
        Female
    7 9 6 22
        Male
    15 13 16 44

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo to match RV521 (The placebo group was split equally across the 2 dose groups such that subjects received placebo at dose level 200 mg in Cohort 1 and at 350 mg in Cohort 2).

    Reporting group title
    200mg RV521
    Reporting group description
    200 mg of RV521 (Cohort 1)

    Reporting group title
    350mg RV521
    Reporting group description
    350mg of RV521 (Cohort 2)

    Primary: Primary efficacy endpoint

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    End point title
    Primary efficacy endpoint
    End point description
    The analysis of viral load AUC (first dose of IMP to Study Day 12) by nasal wash RT-qPCR, for the ITT-I Analysis Set defined as all randomised subjects who received Challenge Virus and at least one dose of IMP, and met the criterion for laboratory confirmed RSV infection, defined as the presence of viral shedding (measured in nasal wash). The ITT-I analysis set was considered the primary analysis population for efficacy endpoints.
    End point type
    Primary
    End point timeframe
    From the last RT-qPCR measurement collected prior to the first dose of IMP until the last RT-qPCR measurement collected up to Study Day 12 (Quarantine discharge).
    End point values
    Placebo 200mg RV521 350mg RV521
    Number of subjects analysed
    19
    18
    16
    Units: log10 PFUe/mL
        log mean (standard error)
    501.39 ± 86.57
    224.35 ± 37.60
    185.26 ± 31.17
    Statistical analysis title
    Descriptive Statistics
    Statistical analysis description
    AUC descriptive statistics (n, (arithmetic) mean, SD, median, Q1, Q3, minimum and maximum), the Satterthwaite t-test p-value, the difference in mean values (comparison of RV521 dose and placebo) and the associated 95% CI were summarised by treatment group.
    Comparison groups
    Placebo v 200mg RV521 v 350mg RV521
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.007 [1]
    Method
    Sensitivity Analysis
    Confidence interval
    Notes
    [1] - RV521 resulted in statistically significant reduction in AUC of RT-qPCR RSV viral load compared with placebo; difference in mean values compared with placebo of 55.25% (p=0.007) and 63.05% (p=0.002) for the 200 mg and 350 mg RV521 doses respectively

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collected from informed consent until final follow up visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Overall Summary of Adverse Events for Placebo Group
    Reporting group description
    -

    Reporting group title
    Overall summary of Adverse Events for RV521 200mg group
    Reporting group description
    -

    Reporting group title
    Overall summary of Adverse Events for RV521 350mg group
    Reporting group description
    -

    Serious adverse events
    Overall Summary of Adverse Events for Placebo Group Overall summary of Adverse Events for RV521 200mg group Overall summary of Adverse Events for RV521 350mg group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Sub-acute myocarditis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Overall Summary of Adverse Events for Placebo Group Overall summary of Adverse Events for RV521 200mg group Overall summary of Adverse Events for RV521 350mg group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 22 (59.09%)
    12 / 22 (54.55%)
    20 / 22 (90.91%)
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Catheter site paraesthesia
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 22 (13.64%)
    4 / 22 (18.18%)
         occurrences all number
    0
    3
    5
    Abdominal pain lower
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
    4 / 22 (18.18%)
    9 / 22 (40.91%)
         occurrences all number
    1
    4
    11
    Food poisoning
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Lip dry
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 22 (9.09%)
    12 / 22 (54.55%)
         occurrences all number
    2
    2
    12
    Vomiting
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2

    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? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    A substantial amendment related to the change of the Principle Investigator took place after the End of Trial (LSLV) on the 28th November 2017.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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