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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (>=28 Days to <=5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

    Summary
    EudraCT number
    		 2020-002023-11
    Trial protocol
    		 BG   DE   SE   CZ   HU   BE   PL   Outside EU/EEA   EE   LV   SK   IT  
    Global end of trial date
    18 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    53718678RSV3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04583280
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development LLC
    Sponsor organisation address
    920 Route 202, South Raritan New Jersey, 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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001838-PIP01-15
    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
    01 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Main objective of the trial was to evaluate the superiority of rilematovir compared to placebo treatment with respect to the clinical outcome on the respiratory syncytial virus (RSV) Recovery Scale (RRS).
    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 Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 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
    Argentina: 7
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Ukraine: 9
    Worldwide total number of subjects
    28
    EEA total number of subjects
    7
    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)
    20
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 28 subjects with acute respiratory tract infection due to RSV were randomised and treated (8 subjects in Placebo arm and 20 subjects in rilematovir arm). Of these, 27 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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects aged greater than or equal to (>=) 28 days to less than (<) 3 months, >=3 to <6 months, and >=6 months to less than or equal to (<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to rilematovir BID from Days 1 to 7.

    Arm title
    		 Rilematovir
    Arm description
    		 Subjects aged >=28 days to <3 months, >=3 to <6 months, and >=6 months to <=5 years received rilematovir 2.5 milligram per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rilematovir 2.5 mg/kg
    Investigational medicinal product code
    JNJ-53718678
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged >=28 days to <3 months received rilematovir 2.5 mg/kg orally as 20 mg/mL suspension BID from Days 1 to 7.

    Investigational medicinal product name
    Rilematovir 4.5 mg/kg
    Investigational medicinal product code
    JNJ-53718678
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged >=6 months to <=5 years received rilematovir 4.5 mg/kg orally as 20 mg/mL suspension BID from Days 1 to 7.

    Investigational medicinal product name
    Rilematovir 3 mg/kg
    Investigational medicinal product code
    JNJ-53718678
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged >=3 to <6 months received rilematovir 3 mg/kg orally as 20 mg/mL suspension BID from Days 1 to 7.

    Number of subjects in period 1
    		Placebo Rilematovir
    Started
    8
    20
    Completed
    8
    19
    Not completed
    0
    1
         Consent withdrawn parent/caregiver
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged greater than or equal to (>=) 28 days to less than (<) 3 months, >=3 to <6 months, and >=6 months to less than or equal to (<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).

    Reporting group title
    Rilematovir
    Reporting group description
    		 Subjects aged >=28 days to <3 months, >=3 to <6 months, and >=6 months to <=5 years received rilematovir 2.5 milligram per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).

    Reporting group values
    		 Placebo Rilematovir Total
    Number of subjects
    		 8 20 28
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 2 6 8
        Infants and toddlers(28 days-23 months)
    		 6 14 20
    Title for AgeContinuous
    Units: months
        arithmetic mean (standard deviation)
    		 15.3 ± 19.4 16.2 ± 13.67 -
    Title for Gender
    Units: subjects
        Female
    		 6 12 18
        Male
    		 2 8 10

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged greater than or equal to (>=) 28 days to less than (<) 3 months, >=3 to <6 months, and >=6 months to less than or equal to (<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses).

    Reporting group title
    Rilematovir
    Reporting group description
    		 Subjects aged >=28 days to <3 months, >=3 to <6 months, and >=6 months to <=5 years received rilematovir 2.5 milligram per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses).

    Primary: Percentage of Subjects by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category

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    End point title
    		 Percentage of Subjects by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category [1]
    End point description
    RRS was an ordinal scale to assess a subject's clinical status. The RRS provided 7 mutually exclusive categories ordered from best to worst where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental O2 or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicated worst condition. With or without signs/symptoms was defined as the key RSV signs/symptoms resolved (absent or mild) or not resolved assessed by parent/caregiver. Intent-to-Treat-infected (ITT-i) analysis set was analysed. Due to the early termination of study, last day of RRS treatment (Day 8) was considered instead of the original planned day defined as when 50% subjects would have been discharged.
    End point type
    Primary
    End point timeframe
    Baseline to Day 8
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Percentage of subjects
    number (not applicable)
        Home without symptoms
    25.0
    31.6
        Home with symptoms
    50.0
    26.3
        Ward without supplemental oxygen/feeding/hydration
    25.0
    36.8
        Ward with supplemental or feeding/hydration
    0
    5.3
        ICU without mechanical ventilation
    0
    0
        Requiring mechanical ventilation
    0
    0
        Death
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms Questionnaire at Day 8

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    End point title
    		 Percentage of Subjects Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms Questionnaire at Day 8
    End point description
    Clinically resolved was defined as subject required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ClinRO signs/symptoms questionnaire. Clinically resolved Key RSV signs/symptoms were assessed based on clinician's observations as resolved if subject had no retractions, tachypnea, tachycardia, breathing problems (nasal flaring, head bobbing, grunting); cough (resolved if little or no coughing or occasional strong cough or sometimes productive) and wheezing (resolved if no wheezing or terminal expiratory wheezing or only with stethoscope). ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Percentage of subjects
        number (not applicable)
    37.5
    31.6
    No statistical analyses for this end point

    Secondary: Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) Questionnaire After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours

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    End point title
    		 Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) Questionnaire After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours
    End point description
    Time from first dose of study intervention to first resolution of Key RSV signs/symptoms was evaluated based on ObsRO assessment after free of supplementation (O2/feeding/hydration) for at least 24 hours. Clinically resolved was defined as subject required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ObsRO signs/symptoms questionnaire. Resolution of key Signs/Symptoms assessment was based on observations of child’s parent/caregiver as resolved if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, little coughing without problems). Kaplan-Meier method was used for estimation. ITT-i analysis set was analysed. 99999 indicated upper limit of 95% confidence interval (CI) in placebo arm could not be estimated due to low number of subjects with events.
    End point type
    Secondary
    End point timeframe
    up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Hours
        median (confidence interval 95%)
    237.0 (114.38 to 99999)
    144.8 (96.09 to 210.93)
    No statistical analyses for this end point

    Secondary: Time From Discharge to Resolution of key RSV Signs/Symptoms Based on ObsRO Sign/Symptoms Questionnaire

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    End point title
    		 Time From Discharge to Resolution of key RSV Signs/Symptoms Based on ObsRO Sign/Symptoms Questionnaire
    End point description
    Time (hours) from discharge from the hospital to resolution of key RSV Signs/Symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) was planned to be reported. ObsRO Signs/Symptoms questionnaire was based on observations by child’s parent/caregiver to assess resolution of key Signs/symptoms of RSV disease as resolved: if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, a little coughing without problems caused by coughing). Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to 21 Days
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - Data for this endpoint was not analysed as the study was terminated early.
    [3] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Time From First Dosing to end of Oxygen Supplementation

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    End point title
    		 Time From First Dosing to end of Oxygen Supplementation
    End point description
    Time from first dosing to end of oxygen supplementation was planned to be analysed. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [4] - Data for this endpoint was not analysed as the study was terminated early.
    [5] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Post-baseline RSV-Related Complications

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    End point title
    		 Number of Subjects with Post-baseline RSV-Related Complications
    End point description
    RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Subjects were counted only once for any given event, regardless of the number of times they actually experienced the event. ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Subjects were counted only once for any given event, regardless of the number of times they actually experienced the event.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Subjects
    1
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE with an onset after the initiation study drug (Day 1) up to end of study (Day 35). Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    20
    Units: Subjects
    5
    11
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Clinical Laboratory Values

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    End point title
    		 Number of Subjects with Abnormalities in Clinical Laboratory Values
    End point description
    Number of subjects with abnormally low (AL) and abnormally high (AH) values of bicarbonate, direct bilirubin, urea nitrogen, basophils, eosinophils, erythrocyte (Ery). mean corpuscular hemoglobin (HGB) concentration (conc), Ery. mean corpuscular hemoglobin, erythrocytes, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes compared to baseline as assessed based on the investigator's discretion were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention. Here, N (number of subjects analysed) signifies subjects evaluated for this endpoint and 'n' (number analysed) signifies number of subjects with available data at each specified category.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    18
    Units: Subjects
        Bicarbonate- Abnormally low (n =8, 17)
    1
    3
        Bicarbonate- Abnormally high (n =8, 17)
    0
    0
        Direct bilirubin- Abnormally low (n =7, 16)
    2
    9
        Direct bilirubin- Abnormally high (n =7, 16)
    0
    0
        Urea nitrogen- Abnormally low (n =8, 17)
    1
    3
        Urea nitrogen- Abnormally high (n =8, 17)
    0
    0
        Basophils- Abnormally low (n =7, 17)
    0
    0
        Basophils- Abnormally high(n =7, 17)
    0
    1
        Eosinophils- Abnormally low (n =7, 17)
    0
    0
        Eosinophils- Abnormally high (n =7, 17)
    5
    12
        Ery. mean corpuscular HGB conc.-AL (n =7, 17)
    1
    3
        Ery. mean corpuscular HGB conc.-AH (n =7, 17)
    0
    0
        Ery. mean corpuscular hemoglobin-AL (n =7, 18)
    0
    3
        Ery. mean corpuscular hemoglobin-AH (n =7, 18)
    0
    0
        Erythrocytes- Abnormally low (n =7, 18)
    0
    0
        Erythrocytes- Abnormally high (n =7, 18)
    0
    2
        Leukocytes- Abnormally low (n =7, 18)
    1
    1
        Leukocytes- Abnormally high (n =7, 18)
    0
    5
        Lymphocytes- Abnormally low (n =7, 17)
    0
    0
        Lymphocytes- Abnormally high (n =7, 17)
    0
    3
        Monocytes- Abnormally low (n =7, 17)
    1
    4
        Monocytes- Abnormally high (n =7, 17)
    0
    0
        Neutrophils- Abnormally low (n =7, 17)
    4
    10
        Neutrophils- Abnormally high(n =7, 17)
    0
    0
        Reticulocytes- Abnormally low (n =7, 18)
    0
    0
        Reticulocytes- Abnormally high (n =7, 18)
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Electrocardiograms (ECG)

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    End point title
    		 Number of Subjects with Abnormalities in Electrocardiograms (ECG)
    End point description
    Number of subjects with abnormally low and abnormally high values of ECG Abnormalities (PR Interval and RR Interval) as assessed based on the investigator's discretion were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    20
    Units: Subjects
        PR Interval- Abnormally low
    0
    0
        PR Interval- Abnormally high
    0
    1
        RR Interval- Abnormally low
    1
    7
        RR Interval- Abnormally high
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Vital Signs

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    End point title
    		 Number of Subjects with Abnormalities in Vital Signs
    End point description
    Number of subjects with abnormally low and abnormally high vital signs as assessed based on the investigator's discretion were reported. Abnormal vital signs included systolic blood pressure (SBP) (millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (mmHg), pulse rate (Beats per minute), respiratory rate (Breaths per minute), temperature (Celsius) and oxygen saturation (%). Safety analysis set included all subjects who received at least 1 dose of study intervention. Here, 'n' (number analysed) signifies number of subjects with available data at specified categories.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    20
    Units: Subjects
        SBP- Abnormally low (n=8,20)
    0
    0
        SBP- Abnormally high (n=8,20)
    0
    4
        DBP- Abnormally low (n=8,20)
    0
    0
        DBP- Abnormally high (n=8,20)
    1
    3
        Pulse Rate- Abnormally low (n=8,20)
    0
    0
        Pulse Rate- Abnormally high (n=8,20)
    1
    2
        Respiratory Rate- Abnormally low (n=8,20)
    0
    0
        Respiratory Rate- Abnormally high (n=8,20)
    0
    3
        Temperature - Abnormally low (n=8,20)
    0
    0
        Temperature - Abnormally high (n=8,20)
    1
    0
        Oxygen Saturation- Abnormally low (n=8,19)
    0
    1
        Oxygen Saturation- Abnormally high (n=8,19)
    0
    0
    No statistical analyses for this end point

    Secondary: Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire

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    End point title
    		 Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire
    End point description
    Time to resolution of signs/symptoms of RSV disease symptoms was planned to be reported. Resolution of signs/symptoms assessment was based on observations of child’s parent/caregiver as per ObsRO signs/symptoms questionnaire as resolved if general illness behavior appeared well, less active, less interested in playing/toys, tired more easily; sleep disturbance(as usual, little more restless, disturbed); crying: resolved if subject cried(as usual/cried more than usual but calmed if held/soothed);feeding problems: as usual/little less than usual; no dehydration(dark yellow urine/less urine/soft spot on top of head sunk in/sunken eyes/dry skin or lips);retractions (belly sucked in when breathing in/ribs more visible than usual when breathing in/skin at base of throat sucked in when breathing in),no tachypnea/tachycardia; no nasal signs; no breathing problems. Data for this endpoint was not analysed as study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - Data for this endpoint was not analysed as the study was terminated early.
    [7] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: ObsRO Signs/Symptoms Questionnaire Scores

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    End point title
    		 ObsRO Signs/Symptoms Questionnaire Scores
    End point description
    ObsRO Signs/Symptoms questionnaire was used to monitor specific signs/symptoms of RSV disease based on observations by child’s parent/caregiver. It consisted of 9 items, each item was scored as follows: sleep disturbance =0,1,2,3; crying =0,1,2,3; illness behavior =0,1,2,3; nasal signs =0,1,2; breathing problems [tachypnea, tachycardia, retractions] =0,2,3; breathing sounds =0,3; cough =0,1,2,3; feeding problems =0,1,2,3; and dehydration =0,1,2,3. In each item score of 0 and 1 indicated signs/symptoms resolved and score of 2 and 3 indicated signs/symptoms not resolved. A summary score was derived (mean of the item scores) and rated on a 4-point scale, with scores ranging from 0 to 3, higher score indicated, worse/higher severity of sign/symptom. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [8] - Data for this endpoint was not analysed as the study was terminated early.
    [9] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Change From Baseline in ObsRO Signs/Symptoms Questionnaire Scores Over Time

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    End point title
    		 Change From Baseline in ObsRO Signs/Symptoms Questionnaire Scores Over Time
    End point description
    ObsRO Signs/Symptoms questionnaire was used to monitor specific signs/symptoms of RSV disease based on observations by child’s parent/caregiver. It consisted of 9 items, each item was scored as follows: sleep disturbance =0,1,2,3; crying =0,1,2,3; illness behavior =0,1,2,3; nasal signs =0,1,2; breathing problems [tachypnea, tachycardia, retractions] =0,2,3; breathing sounds =0,3; cough =0,1,2,3; feeding problems =0,1,2,3; and dehydration =0,1,2,3. In each item score of 0 and 1 indicated signs/symptoms resolved and score of 2 and 3 indicated signs/symptoms not resolved. A summary score was derived (mean of the item scores) and rated on a 4-point scale, with scores ranging from 0 to 3, higher score indicated, worse/higher severity of sign/symptom. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [10] - Data for this endpoint was not analysed as the study was terminated early.
    [11] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Time to Improvement in RSV disease Based on ObsRO General Health Questions (GHQ)

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    End point title
    		 Time to Improvement in RSV disease Based on ObsRO General Health Questions (GHQ)
    End point description
    ObsRO GHQ was a 5-item questionnaire to evaluate parent/caregiver's general impression of child’s RSV disease severity, change in RSV disease, and overall health status. Subject had to choose one answer from multiple options for each question i.e. how would you rate child’s RSV now: recovered, very mild, mild, moderate, severe, very severe); would you say child’s RSV had improved is about same or is worse than when child entered study: very much improved, much improved, a little improved, about the same, a little worse, much worse, very much worse); overall, how is the child’s health now: excellent, very good, good, fair, poor, very poor; has the child’s health returned to normal how the child was before RSV: Yes, No); which of these did you use to decide your answers: what I saw myself, what I saw and what another caregiver told me, what another caregiver told me. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [12] - Data for this endpoint was not analysed as the study was terminated early.
    [13] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Time to Resolution of Signs/Symptoms of RSV Disease as Assessed by ClinRO Signs/Symptoms Questionnaire

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    End point title
    		 Time to Resolution of Signs/Symptoms of RSV Disease as Assessed by ClinRO Signs/Symptoms Questionnaire
    End point description
    Time to resolution from first dose of study drug until first time of resolution of all RSV Symptoms was planned to be reported. Clinically resolved RSV signs/symptoms were assessed based on clinician's observations by ClinRO signs/symptoms questionnaire as activity level (resolved if subject was alert and active or irritable), sleep disturbance (resolved if subject was normal or occasional restlessness/disturbed), feeding problems (resolved if subject took >75% of normal amount of feeds via usual route), resolved if subject had no dehydration, retractions, tachypnea and tachycardia, nasal secretions (resolved if subjects had none or minimal/moderate nasal secretions), had no breathing problems, cough (resolved if little or no coughing/occasional strong cough/sometimes productive) and wheezing (resolved if no wheezing/terminal expiratory wheezing/only with stethoscope). Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [14] - Data for this endpoint was not analysed as the study was terminated early.
    [15] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: ClinRO Signs/Symptoms Questionnaire Scores

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    End point title
    		 ClinRO Signs/Symptoms Questionnaire Scores
    End point description
    ClinRO Signs/Symptoms questionnaire was based on observations by clinician and it consisted of 12 items, each item was scored as follows: activity level =0,1,2,3; sleep disturbance =0,1,2,3; retractions =2,3; tachypnea =2; breathing problems =0,2,3; tachycardia =0,2; feeding problems =0,2,3; cough =0,1,3; nasal secretions =0,1,2; wheezing =0,1,2,3; and dehydration =0,3. In each item score of 0 and 1 indicated signs/symptoms were resolved and score of 2 and 3 indicated signs/symptoms were not resolved. A summary score was derived =mean of the item scores) and rated on a 4-point scale, with scores ranging from 0 to 3, higher score indicated, worse/higher severity of sign/symptom. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [16] - Data for this endpoint was not analysed as the study was terminated early.
    [17] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Change From Baseline in ClinRO Signs/Symptoms Questionnaire Scores

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    End point title
    		 Change From Baseline in ClinRO Signs/Symptoms Questionnaire Scores
    End point description
    ClinRO Signs/Symptoms questionnaire was based on observations by clinician and it consisted of 12 items, each item was scored as follows: activity level =0,1,2,3; sleep disturbance =0,1,2,3; retractions =2,3; tachypnea =2; breathing problems =0,2,3; tachycardia =0,2; feeding problems =0,2,3; cough =0,1,3; nasal secretions =0,1,2; wheezing =0,1,2,3; and dehydration =0,3. In each item score of 0 and 1 indicated signs/symptoms were resolved and score of 2 and 3 indicated signs/symptoms were not resolved. A summary score was derived =mean of the item scores) and rated on a 4-point scale, with scores ranging from 0 to 3, higher score indicated, worse/higher severity of sign/symptom. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [18] - Data for this endpoint was not analysed as the study was terminated early.
    [19] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Change From Baseline in ClinRO GHQ Over Time

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    End point title
    		 Change From Baseline in ClinRO GHQ Over Time
    End point description
    ClinRO GHQ was a 3 items questionnaire to evaluate the clinician’s general impression of the child’s RSV severity, change in RSV disease, and overall health status. Subject had to choose one answer from multiple options for each question i.e. do you have any concerns relating to the subject’s overall condition (no concerns [condition is stable or improving], some concerns [may become unstable/requires close observation], extremely concerned [unstable, requires immediate medical review]; overall, how would you rate the subject’s current health status (excellent, good, fair, poor); with respect to the child’s RSV infection, how would you describe the child’s health now compared to the baseline assessment (very much worse, much worse, a little worse, unchanged a little improved, much very improved, much improved. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [20] - Data for this endpoint was not analysed as the study was terminated early.
    [21] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Time to Hospital Discharge From Start of Dosing

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    End point title
    		 Time to Hospital Discharge From Start of Dosing
    End point description
    Time (in hours) from first dose of study intervention to first hospital discharge was planned to be analysed. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [22] - Data for this endpoint was not analysed as the study was terminated early.
    [23] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Time to Readiness for Hospital Discharge

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    End point title
    		 Time to Readiness for Hospital Discharge
    End point description
    Hospital discharge readiness referred to a subject having improved respiratory effort (example: improved retractions, stable respiratory rate), improved O2 saturation to greater than or equal to (>=) 92 percent (%) without need for supplemental oxygen, fever control, adequate hydration/feeding without supplementation, stable and/or baseline mental status. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [24] - Data for this endpoint was not analysed as the study was terminated early.
    [25] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Required Intensive Care Unit (ICU) Stay After First Dose of Rilematovir

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    End point title
    		 Percentage of Subjects Required Intensive Care Unit (ICU) Stay After First Dose of Rilematovir
    End point description
    Percentage of subjects required ICU stay were analysed and reported. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects with no ICU stay before first dose of rilematovir.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    6
    17
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Requiring ICU Stay

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    End point title
    		 Duration of Requiring ICU Stay
    End point description
    Duration (in hours) of requiring ICU stay was defined as total number of hours a subject experienced an ICU stay from first dose of rilematovir until study termination, calculated as the sum of all separate records of ICU stay. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects who required ICU stay before first dose of rilematovir and continued after first dose plus subjects who required ICU stay after first dose of drug without prior ICU stay.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    2
    2
    Units: hours
        arithmetic mean (standard deviation)
    66.46 ± 24.145
    40.83 ± 22.822
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring Re-hospitalization for Respiratory/other Reasons

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    End point title
    		 Percentage of Subjects Requiring Re-hospitalization for Respiratory/other Reasons
    End point description
    Percentage of subjects requiring re-hospitalization (subjects re-hospitalized [ward or ICU] after been discharged from hospital) for respiratory/other reasons were reported. ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring Oxygen Supplementation After First Dose of Rilematovir

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    End point title
    		 Percentage of Subjects Requiring Oxygen Supplementation After First Dose of Rilematovir
    End point description
    Percentage of subjects requiring any type of oxygen supplementation (invasive mechanical ventilation, non-invasive mechanical ventilation and non-invasive non-mechanical ventilation) were reported. ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects with no use of oxygen supplementation before first dose of rilematovir.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    6
    13
    Units: Percentage of subjects
        number (not applicable)
    16.7
    30.8
    No statistical analyses for this end point

    Secondary: Duration of Oxygen Supplementation

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    End point title
    		 Duration of Oxygen Supplementation
    End point description
    Duration (in hours) of oxygen supplementation was defined as total number of hours a subject used supplemental oxygen from first dose of rilematovir until study termination, calculated as the sum of all separate records of supplementation. ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects required oxygen supplementation before first dose of rilematovir and continued after first dose plus subjects who required oxygen supplementation after first dose of rilematovir without prior oxygen supplementation.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    3
    10
    Units: Hours
        arithmetic mean (standard deviation)
    39.91 ± 26.146
    66.59 ± 51.956
    No statistical analyses for this end point

    Secondary: Time to end of Supplemental Feeding/hydration

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    End point title
    		 Time to end of Supplemental Feeding/hydration
    End point description
    Time (in hours) to end of supplemental feeding/hydration was planned to be reported. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: Hours
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [26] - Data for this endpoint was not analysed as the study was terminated early.
    [27] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir

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    End point title
    		 Percentage of Subjects Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir
    End point description
    Percentage of subjects requiring any type of hydration and/or feeding by intravenous (IV) administration or nasogastric tube or percutaneous endoscopic gastrostomy were reported. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects with no use of feeding/hydration supplementation before 1st dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    3
    15
    Units: Percentage of subjects
        number (not applicable)
    33.3
    0
    No statistical analyses for this end point

    Secondary: Duration of Supplemental Feeding/hydration

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    End point title
    		 Duration of Supplemental Feeding/hydration
    End point description
    Duration (in hours) of supplemental feeding/hydration was defined as total number of hours a subject was administered feeding/hydration supplementation from first dose of rilematovir until study termination, calculated as the sum all separate records of supplementation use per subject. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects required supplemental feeding/hydration before first dose of rilematovir and continued after first dose plus subjects required supplemental feeding/hydration after first dose of rilematovir without prior supplemental feeding/hydration.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    6
    4
    Units: Hours
        arithmetic mean (standard deviation)
    43.13 ± 41.526
    31.96 ± 21.311
    No statistical analyses for this end point

    Secondary: Time to end of Supplemental Oxygen and/or Feeding/hydration

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    End point title
    		 Time to end of Supplemental Oxygen and/or Feeding/hydration
    End point description
    Time to end of supplemental oxygen and/or feeding/hydration was planned to be analysed. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: Hours
        arithmetic mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [28] - Data for this endpoint was not analysed as the study was terminated early.
    [29] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Medical Encounters and Treatments

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    End point title
    		 Number of Subjects with Medical Encounters and Treatments
    End point description
    Medical resource utilization was assessed by number of medical care encounters. Medical encounters referred as physician or emergency room visits, tests and procedures, and medications, surgeries and other selected procedures, inpatient and outpatient. ITT-i analysis set included all randomised subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Subjects
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Antibiotic Treatment Episodes

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    End point title
    		 Number of Subjects with Antibiotic Treatment Episodes
    End point description
    Number of subjects with antibiotic treatment episodes were planned to be reported. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: Subjects
    Notes
    [30] - Data for this endpoint was not analysed as the study was terminated early.
    [31] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Systemic or Inhaled Corticosteroids and Bronchodilators use

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    End point title
    		 Number of Subjects with Systemic or Inhaled Corticosteroids and Bronchodilators use
    End point description
    Number of subjects with systemic or inhaled corticosteroids and bronchodilators use were planned to be reported. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [32]
    0 [33]
    Units: Subjects
    Notes
    [32] - Data for this endpoint was not analysed as the study was terminated early.
    [33] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 8

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    End point title
    		 Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 8
    End point description
    Area under the RSV viral load-time curve was planned to be analysed. RSV viral load was planned to be measured by quantitative reverse transcription (qRT)- polymerase chain reaction (PCR) in the mid-turbinate (MT) nasal swab specimens. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 8
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [34]
    0 [35]
    Units: nanogram*hour per millilitre
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [34] - Data for this endpoint was not analysed as the study was terminated early.
    [35] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21

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    End point title
    		 RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21
    End point description
    Antiviral activity was determined based on measurements of RSV viral load which was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the mid-turbinate (MT) nasal swab specimens. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, 'n' (number analysed) signifies number of subjects with data evaluable at each specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2, 3, 5, 8, 14 and 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: log10 copies per millilitre
    arithmetic mean (standard deviation)
        Baseline (n =8,18)
    7.031 ± 1.9995
    6.286 ± 1.3671
        Day 2 (n =8,19)
    6.000 ± 1.5678
    5.579 ± 1.5668
        Day 3 (n =8,19)
    5.465 ± 1.7454
    4.981 ± 1.9530
        Day 5 (n =8,19)
    4.066 ± 1.5565
    4.132 ± 1.5199
        Day 8 (n =8,18)
    1.373 ± 2.0865
    2.156 ± 2.1681
        Day 14 (n =7,17)
    1.217 ± 2.1478
    0.709 ± 1.3389
        Day 21 (n =7,17)
    0.414 ± 1.0961
    0.464 ± 1.4547
    No statistical analyses for this end point

    Secondary: Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21

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    End point title
    		 Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21
    End point description
    Antiviral activity was determined based on measurements of RSV viral load which was measured by qRT-PCR, in the MT nasal swab specimens. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects evaluated for this endpoint and 'n' (number analysed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2, 3, 5, 8, 14 and 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    18
    Units: log10 copies per millitre
    arithmetic mean (standard deviation)
        Day 2 (n =8, 18)
    -1.031 ± 0.6091
    -0.825 ± 1.2906
        Day 3 (n =8, 18)
    -1.566 ± 2.2167
    -1.436 ± 1.5185
        Day 5 (n =8, 18)
    -2.965 ± 1.9154
    -2.241 ± 1.3393
        Day 8 (n =8, 17)
    -5.658 ± 1.9872
    -4.126 ± 1.8461
        Day 14 (n =7, 17)
    -5.693 ± 2.2654
    -5.640 ± 2.0261
        Day 21 (n =7, 16)
    -7.207 ± 1.3201
    -5.789 ± 1.9560
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Undetectable RSV Viral Load

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    End point title
    		 Percentage of Subjects with Undetectable RSV Viral Load
    End point description
    Percentage of subjects with undetectable RSV viral load was analysed. ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, 'n' (number analysed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2, 3, 5, 8, 14 and 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    8
    19
    Units: Percentage of subjects
    number (not applicable)
        Baseline (n= 8,18)
    0
    0
        Day 2 (n= 8,19)
    0
    0
        Day 3 (n= 8,19)
    0
    5.3
        Day 5 (n= 8,19)
    0
    0
        Day 8 (n= 8,18)
    62.5
    44.4
        Day 14 (n= 7,17)
    71.4
    76.5
        Day 21 (n= 7,17)
    85.7
    88.2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences

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    End point title
    		 Number of Subjects with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences
    End point description
    Number of subjects with post-baseline changes in the RSV F-gene compared with baseline sequences was planned to be reported. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 21
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    0 [36]
    0 [37]
    Units: Subjects
    Notes
    [36] - Data for this endpoint was not analysed as the study was terminated early.
    [37] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of Rilematovir

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    End point title
    		 Plasma Concentrations of Rilematovir [38]
    End point description
    Plasma concentrations of rilematovir was analysed. Subject wise data were reported for this endpoint. Pharmacokinetics analysis set (PKAS) included subjects who had received at least 1 dose of rilematovir and had at least 1 valid blood sample drawn for Pharmacokinetics analysis. No summary analysis was done as study was terminated early and subject wise data were reported. Here, "n" signifies specific subject with data available at specified timepoint.
    End point type
    Secondary
    End point timeframe
    1 hour Post-dose (Day 1) and pre-dose (Day 2)
    Notes
    [38] - 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: Endpoint was planned to be analysed for specified arms only.
    End point values
    		 Rilematovir
    Number of subjects analysed
    18
    Units: nanogram per millilitre
    number (not applicable)
        Subject 1 Day 1 (n=1)
    1450
        Subject 2 Day 1 (n=1)
    1750
        Subject 3 Day 1 (n=1)
    72.5
        Subject 4 Day 1 (n=1)
    656
        Subject 5 Day 1 (n=1)
    918
        Subject 6 Day 1 (n=1)
    1050
        Subject 7 Day 1 (n=1)
    135
        Subject 8 Day 1 (n=1)
    1730
        Subject 9 Day 1 (n=1)
    602
        Subject 10 Day 1 (n=1)
    1810
        Subject 11 Day 1 (n=1)
    1640
        Subject 12 Day 1 (n=1)
    3760
        Subject 13 Day 1 (n=1)
    561
        Subject 14 Day 1 (n=1)
    127
        Subject 15 Day 1 (n=1)
    787
        Subject 16 Day 1 (n=1)
    2020
        Subject 17 Day 1 (n=1)
    157
        Subject 18 Day 1 (n=1)
    1260
        Subject 1 Day 2 (n=1)
    134
        Subject 2 Day 2 (n=1)
    281
        Subject 3 Day 2 (n=1)
    5.74
        Subject 5 Day 2 (n=1)
    417
        Subject 6 Day 2 (n=1)
    828
        Subject 7 Day 2 (n=1)
    1030
        Subject 8 Day 2 (n=1)
    339
        Subject 9 Day 2 (n=1)
    186
        Subject 10 Day 2 (n=1)
    687
        Subject 11 Day 2 (n=1)
    1750
        Subject 12 Day 2 (n=1)
    4650
        Subject 13 Day 2 (n=1)
    311
        Subject 14 Day 2 (n=1)
    77.3
        Subject 15 Day 2 (n=1)
    749
        Subject 16 Day 2 (n=1)
    457
        Subject 17 Day 2 (n=1)
    493
        Subject 18 Day 2 (n=1)
    2930
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)

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    End point title
    		 Percentage of Subjects With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)
    End point description
    Acceptability and palatability were assessed by clinician electronic clinical outcome assessment (eCOA) questionnaire which consisted of 7 questions, 1- child took medicine easily, 2- disgusted expressions after tasting medicine, 3- cried after tasting medicine, 4- would not open mouth or turned head away to avoid medicine, 5- spit out or coughed out medicine, 6- gagged, 7- vomited (within 2 minutes of swallowing medicine). ITT-i analysis set included all randomized subjects who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis. Here, N (number of subjects analysed) signifies subjects evaluated for this endpoint. Reported only those categories which had data for at least one reporting arm.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Placebo Rilematovir
    Number of subjects analysed
    7
    15
    Units: Percentage of subjects
    number (not applicable)
        Child took medicine easily
    85.7
    86.7
        Disgusted expressions after tasting medicine
    0
    13.3
        Did not open mouth or turned head away
    14.3
    6.7
        Spit out or coughed out medicine
    14.3
    0
        Gagged
    0
    6.7
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Rilematovir

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Rilematovir [39]
    End point description
    Cmax of rilematovir was planned to be analysed. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to Day 35
    Notes
    [39] - 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: Endpoint was planned to be analysed for specified arms only.
    End point values
    		 Rilematovir
    Number of subjects analysed
    0 [40]
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [40] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Secondary: Pre dose Plasma Concentration (Ctrough) of Rilematovir

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    End point title
    		 Pre dose Plasma Concentration (Ctrough) of Rilematovir [41]
    End point description
    Ctrough of rilematovir was planned to be analysed. Data for this endpoint was not analysed as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 1
    Notes
    [41] - 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: Endpoint was planned to be analysed for specified arms only.
    End point values
    		 Rilematovir
    Number of subjects analysed
    0 [42]
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [42] - Data for this endpoint was not analysed as the study was terminated early.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 35
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects aged >=28 days to <3 months, >=3 to <6 months and >=6 months to <=5 years received placebo matching to rilematovir BID from Days 1 to 7 (14 consecutive doses).

    Reporting group title
    Rilematovir
    Reporting group description
    		 Subjects aged >=28 days to <3 months, >=3 to <6 months and >=6 months to <=5 years received 2.5, 3 and 4.5 mg/kg rilematovir respectively as 20 mg/mL suspension BID from Days 1 to 7 (14 consecutive doses).

    Serious adverse events
    		 Placebo Rilematovir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Parainfluenzae Virus Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Rilematovir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
    10 / 20 (50.00%)
    Investigations
    Eosinophil Count Increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Blood Magnesium Decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Oxygen Saturation Decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Ventricular Extrasystoles
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Neutrophilia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Extravasation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Faeces Discoloured
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory Distress
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Eczema Infantile
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Onychomadesis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin Exfoliation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypermagnesaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 May 2021
    Amendment 1 included the following changes: addition of estimand language for the primary endpoint, revised assessments for follow-up of subjects who prematurely discontinued the study intervention/the study, inclusion criterion was updated to clarify correction of gestational age applied only to subjects born preterm, inclusion criterion 5 was updated to ensure enrollment of subjects with at least moderate RSV disease severity who were more likely to benefit from RSV treatment, protocol-defined RRS categories were further specified, additional laboratory assessments were added to further evaluate hepatobiliary effects, values for vital sign abnormalities for age group 3 to less than or equal to (<=) 5 years of age were updated, and PRESORS timing and instructions were clarified and minor changes were incorporated.

    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 collection and analysis was not performed for few secondary endpoints.
    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
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