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    Clinical Trial Results:
    A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-related Disease Progression

    Summary
    EudraCT number
    2020-005980-30
    Trial protocol
    SE   DE   ES   IT   PL   HU   BG  
    Global end of trial date
    14 Apr 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Apr 2023
    First version publication date
    14 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    53718678RSV2008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04978337
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    14 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Oct 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: 1
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    5
    EEA total number of subjects
    3
    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)
    4
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    5 randomised subjects received study treatment and were included in the analysis. Out of 5, 4 subjects completed 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
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subject received oral dose of placebo matching to rilematovir twice daily for 7 days.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to rilematovir twice daily for 7 days.

    Arm title
    Rilematovir 250 mg bid
    Arm description
    Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Rilematovir
    Investigational medicinal product code
    Other name
    JNJ-53718678
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received rilematovir 250 mg twice daily for 7 days.

    Number of subjects in period 1
    Placebo Rilematovir 250 mg bid
    Started
    1
    4
    Completed
    1
    3
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subject received oral dose of placebo matching to rilematovir twice daily for 7 days.

    Reporting group title
    Rilematovir 250 mg bid
    Reporting group description
    Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.

    Reporting group values
    Placebo Rilematovir 250 mg bid Total
    Number of subjects
    1 4 5
    Age categorical
    Units: Subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    1 3 4
        From 65-84 years
    0 1 1
        85 years and over
    0 0 0
    Age continuous
    Here,'99999' indicated that standard deviation could not be calculated as only one subject was available for analysis.
    Units: years
        arithmetic mean (standard deviation)
    55 ( 99999 ) 51.8 ( 2.9 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    1 2 3
        Male
    0 2 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subject received oral dose of placebo matching to rilematovir twice daily for 7 days.

    Reporting group title
    Rilematovir 250 mg bid
    Reporting group description
    Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline [1]
    End point description
    RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by RiiQ symptom scale score at baseline was reported. RiiQ symptom scale was a 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. Intent-to-Treat infected (ITT-i) analysis set included subjects who were randomised and treated (at least 1 dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (positive test by central laboratory analysis) were excluded. Here, 'n' (number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    1.25
        Subject 2 (n=0, 1)
    99999
    1.25
        Subject 3 (n=0, 1)
    99999
    1.25
        Subject 4 (n=0, 1)
    99999
    2.25
        Subject 5 (n=1, 0)
    2.25
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 [2]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 3 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher scores indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 3
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    1
    Units: Scored on a scale
    number (not applicable)
        Subject 3 (n=0, 1)
    99999
    0.75
        Subject 5 (n=1, 0)
    1.75
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 [3]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 8 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher scores indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 8
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    1.25
        Subject 2 (n=0, 1)
    99999
    1.25
        Subject 3 (n=0, 1)
    99999
    0.75
        Subject 5 (n=1, 0)
    0.5
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 [4]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 14 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 14
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    1.25
        Subject 2 (n=0, 1)
    99999
    1
        Subject 3 (n=0, 1)
    99999
    0
        Subject 5 (n=1, 0)
    0
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 [5]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 21 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 21
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    0
        Subject 2 (n=0, 1)
    99999
    1
        Subject 3 (n=0, 1)
    99999
    0
        Subject 5 (n=1, 0)
    0
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 [6]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 28 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 28
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    0.5
        Subject 2 (n=0, 1)
    99999
    0.75
        Subject 3 (n=0, 1)
    99999
    0
        Subject 5 (n=1, 0)
    0
    99999
    No statistical analyses for this end point

    Primary: Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35

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    End point title
    Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 [7]
    End point description
    RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 35 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Primary
    End point timeframe
    Day 35
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics was planned for this primary endpoint.
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: Scores on a scale
    number (not applicable)
        Subject 1 (n=0, 1)
    99999
    0
        Subject 2 (n=0, 1)
    99999
    0
        Subject 3 (n=0, 1)
    99999
    0
        Subject 5 (n=1, 0)
    0
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Post-Baseline RSV-related Complications

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    End point title
    Percentage of Subjects with Post-Baseline RSV-related Complications
    End point description
    RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases [such as chronic obstructive pulmonary disease {COPD} and asthma]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure [CHF] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this endpoint. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation

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    End point title
    Percentage of Subjects with New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
    End point description
    New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
    number (not applicable)
        New antibiotic use
    0
    25.0
        Systematic/inhaled corticosteroids,bronchodilators
    0
    25.0
        Home oxygen supplementation
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection 

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    End point title
    Percentage of Subjects with Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection 
    End point description
    Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
    number (not applicable)
        Unscheduled outpatient clinic visits
    0
    25.0
        Emergency room visits
    0
    0
        Hospitalization for respiratory infection
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance

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    End point title
    Percentage of Subjects Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
    End point description
    Percentage of subjects meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
        number (not applicable)
    0
    25.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse events (AEs) is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent. Safety analysis set included all subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Abnormal Clinical Laboratory Findings

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    End point title
    Percentage of Subjects with Treatment-emergent Abnormal Clinical Laboratory Findings
    End point description
    Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined by division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild (transient or mild discomfort;no medical intervention/therapy required); Grade 2: moderate (mild-moderate limitation in activity-some assistance may be needed;no or minimal medical intervention/therapy required); Grade 3: severe(severe marked limitation in activity, some assistance usually required;medical intervention/therapy required, hospitalizations possible); Grade 4: life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization care probable). A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
    number (not applicable)
        Decrease in hemoglobin (Grade 2) (n=1,4)
    0
    25
        Increase in glucose (Grade 2)(n=1,4)
    0
    25
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Abnormalities in Electrocardiograms (ECGs)

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    End point title
    Percentage of Subjects with Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
    End point description
    Various ECG variables assessed were heart rate: abnormally low (less than or equal to [<=] 45 beats per minute [bpm]), abnormally high (greater than or equal to [>=] 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec); QTc: borderline prolonged: >450 msec and <=480 msec, prolonged: >480 msec and <=500 msec, pathologicaly prolonged: >500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment-emergent Abnormal Vital Signs Findings

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    End point title
    Percentage of Subjects with Treatment-emergent Abnormal Vital Signs Findings
    End point description
    Abnormal vital parameters included pulse rate: abnormally low:<=45 bpm, abnormally high:>=120 bpm; Systolic Blood Pressure: abnormally low:<=90 millimeter of mercury (mmHg), Grade 1(mild):>140 mmHg to <160 mmHg, Grade 2(moderate): >=160 mmHg to <180 mmHg, Grade 3(severe):>=180 mmHg; Diastolic BP: abnormally low:<=50 mmHg, Grade 1:>90 mmHg to <100 mmHg, Grade 2:>=100 mmHg to <110 mmHg, Grade 3:>=110 mmHg; Respiratory rate: Grade 1(mild):17-20 breaths/minute, Grade 2(moderate):21-25 breaths/minute, Grade 3(severe):>25 breaths/minute, Grade 4(potentially life threatening):intubation; Oxygen saturation: abnormally low:<95%; Temperature: abnormally high:>38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    4
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: RSV Viral Load Over Time

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    End point title
    RSV Viral Load Over Time
    End point description
    RSV viral load (Subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in nasal swab specimens collected at clinic visits and at home. Only those timepoints and RSV subtype (RSV A or RSV B) for which individual subjects had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis) were excluded. Here, 'N'(number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n'(number analyzed) represents number of subjects evaluable at specified timepoints. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 3, 5, 8, 15, 21
    End point values
    Placebo Rilematovir 250 mg bid
    Number of subjects analysed
    1
    3
    Units: log10 copies per millilitre (mL)
    number (not applicable)
        Subject 1: Baseline: RSV B (n= 0, 1)
    99999
    6.87
        Subject 1: Day 3: RSV B (n= 0, 1)
    99999
    5.84
        Subject 1: Day 8: RSV B (n= 0, 1)
    99999
    0
        Subject 1: Day 15: RSV B (n= 0, 1)
    99999
    0
        Subject 1: Day 21: RSV B (n= 0, 1)
    99999
    0
        Subject 2: Baseline RSV B (n= 0, 1)
    99999
    6.17
        Subject 2: Day 3: RSV B (n= 0, 1)
    99999
    6.71
        Subject 2: Day 5: RSV B (n= 0, 1)
    99999
    0
        Subject 2: Day 8: RSV B (n= 0, 1)
    99999
    0
        Subject 2: Day 15: RSV B (n= 0, 1)
    99999
    0
        Subject 2: Day 21: RSV B (n= 0, 1)
    99999
    0
        Subject 3: Baseline: RSV A (n= 0, 1)
    99999
    6.5
        Subject 3: Day 3: RSV A (n= 0, 1)
    99999
    6.4
        Subject 3: Day 5: RSV A (n= 0, 1)
    99999
    3.37
        Subject 3: Day 8: RSV A (n= 0, 1)
    99999
    2.9
        Subject 3: Day 15: RSV A (n= 0, 1)
    99999
    0
        Subject 3: Day 21: RSV A (n= 0, 1)
    99999
    0
        Subject 5: Baseline: RSV A (n=1, 0)
    7.57
    99999
        Subject 5: Day 3: RSV A (n=1, 0)
    4.94
    99999
        Subject 5: Day 5: RSV A (n=1, 0)
    0
    99999
        Subject 5: Day 8: RSV A (n=1, 0)
    0
    99999
        Subject 5: Day 15: RSV A (n=1, 0)
    0
    99999
        Subject 5: Day 21: RSV A (n=1, 0)
    0
    99999
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Rilematovir 

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    End point title
    Plasma Concentration of Rilematovir  [8]
    End point description
    Plasma concentration of rilematovir was reported. This endpoint was planned to be analyzed for specified arm only. In this endpoint, only those timepoints for which individual subjects had data were reported. Pharmacokinetic (PK) analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Here, 'N' (number of subject analysed) signifies number of subjects with available data for this endpoint .
    End point type
    Secondary
    End point timeframe
    Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up Day 8
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analyzed for specified arm only.
    End point values
    Rilematovir 250 mg bid
    Number of subjects analysed
    3
    Units: Nanograms per millilitre (ng/mL)
    number (not applicable)
        Subject 1: Day 3 (Pre-dose)
    658
        Subject 1: Day 3 (1 hour post dose)
    682
        Subject 1: Follow-up-Day 8
    9.63
        Subject 2: Day 3 (pre-dose)
    15.9
        Subject 2: Day 3 (1 hour post dose)
    465
        Subject 2: Follow-up-Day 8
    494
        Subject 3: Day 1 (1 hour post dose)
    257
        Subject 3: Day 3 (pre-dose)
    2400
        Subject 3: Day 3 (1 hour post dose)
    2960
        Subject 3: Follow-up-Day 8
    3130
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 35
    Adverse event reporting additional description
    Safety analysis set included all subjects who took at least 1 dose of study intervention.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Rilematovir 250 mg
    Reporting group description
    Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received oral dose of placebo matching to rilematovir twice daily for 7 days.

    Serious adverse events
    Rilematovir 250 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Rilematovir 250 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Data could not be reported as only 5 subjects enrolled in this study who did not experience any non-serious adverse events.

    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.
    As the study was terminated early, a low number of subjects were enrolled, hence some efficacy analyses were not performed per change in the planned analysis. Thereby, data were analysed for safety and selected efficacy parameters only.
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