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    Clinical Trial Results:
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

    Summary
    EudraCT number
    2017-001862-56
    Trial protocol
    GB   DE   BE   FI   SK   ES   IE   PT   FR   IT  
    Global end of trial date
    23 Mar 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    31 Oct 2019
    First version publication date
    26 Apr 2019
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CR108367
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03333317
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen- Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen- Cilag International NV, 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-001758-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    23 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study was to determine in hospitalized infants and children who were infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).
    Protection of trial subjects
    The 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. Safety evaluations were based upon the type, incidence, and severity of treatment-emergent adverse events (TEAEs) and adverse events (AEs) of special interest reported throughout the study, and on changes in vital sign measurements, clinical laboratory test results, physical examinations and 12-lead electrocardiograms (ECGs).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Nov 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    0
    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)
    6
    Children (2-11 years)
    1
    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
    On 17 October 2018, the study was stopped prematurely by the sponsor as a precautionary measure, to allow further evaluation and assessment of the new nonclinical pharmacokinetics (PK) and safety findings and determine their relevance to human studies.

    Pre-assignment
    Screening details
    Total 8 subjects that met all the eligibility criteria and had signed an ICF were enrolled, of which 7 subjects were randomized to receive lumicitabine or placebo. One eligible subject was not randomized and treated due to a lack of availability of study drug at the clinical site.

    Period 1
    Period 1 title
    Treatment and Follow-up (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 received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received oral administration of matching placebo.

    Arm title
    Lumicitabine 40/20 mg/kg LD/MD
    Arm description
    Subjects received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.
    Arm type
    Experimental

    Investigational medicinal product name
    Lumicitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine-20 mg/kg twice a day.

    Arm title
    Lumicitabine 60/40 mg/kg LD/MD
    Arm description
    Subjects received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
    Arm type
    Experimental

    Investigational medicinal product name
    Lumicitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine-40mg/kg twice a day.

    Number of subjects in period 1
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Started
    3
    1
    3
    Completed
    3
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).

    Reporting group title
    Lumicitabine 40/20 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.

    Reporting group title
    Lumicitabine 60/40 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.

    Reporting group values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD Total
    Number of subjects
    3 1 3 7
    Title for AgeCategorical
    Units: subjects
        In utero
    0 0 0 0
        Preterm newborn - gestational age < 37 wk
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    2 1 3 6
        Children (2-11 years)
    1 0 0 1
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    0 0 0 0
        From 65 to 84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Title for AgeContinuous
    Here '99999' indicates that the data was not estimated due to only single subject was analyzed.
    Units: months
        arithmetic mean (standard deviation)
    16.0 ± 13.08 17.0 ± 99999 6.3 ± 2.52 -
    Title for Gender
    Units: subjects
        Female
    0 0 1 1
        Male
    3 1 2 6

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).

    Reporting group title
    Lumicitabine 40/20 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.

    Reporting group title
    Lumicitabine 60/40 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.

    Primary: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load

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    End point title
    Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load [1]
    End point description
    AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
    End point type
    Primary
    End point timeframe
    Day 1 to 7: Predose, 0.25 and 2 hours postdose
    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 formal statistical hypothesis testing was planned for this study due to the descriptive nature of this study.
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Copies*Day/milliliters
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [2] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [3] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [4] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Emergent Adverse Event (AE)

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    End point title
    Number of Subjects with Emergent Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Safety analysis set was defined as all subjects who received at least 1 dose of study drug, analyzed as treated.
    End point type
    Secondary
    End point timeframe
    Approximately up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
        number (not applicable)
    3
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Physical Examinations Abnormalities

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    End point title
    Number of Subjects with Clinically Significant Physical Examinations Abnormalities
    End point description
    Number of subjects with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all subjects treated (AST) set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    2
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Emergent Clinical Relevant Vital Signs Abnormalities

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    End point title
    Number of Subjects with Emergent Clinical Relevant Vital Signs Abnormalities
    End point description
    The number of subjects with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation was reported. Safety analysis set was defined as all subjects who received at least 1 dose of study drug, analyzed as treated.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    number (not applicable)
        Systolic Blood Pressure (Abnormally high)
    2
    1
    1
        Diastolic Blood Pressure (Abnormally high)
    1
    1
    0
        Pulse Rate (Abnormally high)
    1
    1
    1
        Respiratory Rate (Abnormally high)
    1
    0
    0
        Temperature (High)
    1
    0
    1
        Oxygen Saturation (Abnormally low)
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Electrocardiogram (ECG) Abnormalities

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    End point title
    Number of Subjects with Electrocardiogram (ECG) Abnormalities
    End point description
    The number of subjects with ECG (PR, QT, QRS, QTc intervals, and heart rate) abnormalities reported. Safety analysis set was defined as all subjects who received at least 1 dose of study drug, analyzed as treated.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    number (not applicable)
        QT Duration
    1
    0
    0
        QTcB: Bazett's Correction Formula
    0
    0
    0
        QTcF: Fridericia's Correction Formula
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)

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    End point title
    Number of Subjects with Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
    End point description
    The number of subjects with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on the DMID toxicity grading scale. Safety analysis set was defined as all subjects who received at least 1 dose of study drug, analyzed as treated.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    number (not applicable)
        Alanine transaminase (ALT): Grade 0
    3
    0
    3
        ALT: Grade 1
    0
    1
    0
        Aspartate Aminotransferase (AST): Grade 0
    3
    1
    3
        Bilirubin: Grade 0
    3
    1
    3
        Creatinine: Grade 0
    3
    1
    2
        Creatinine: Grade 2
    0
    0
    1
        Hypoglycemia: Grade 0
    3
    1
    3
        Hyperglycemia: Grade 0
    3
    1
    3
        Hypokalemia: Grade 0
    3
    1
    3
        Hyperkalemia: Grade 0
    1
    1
    1
        Hyperkalemia: Grade 1
    2
    0
    2
        Hyponatremia: Grade 0
    3
    1
    3
        Hypernatremia: Grade 0
    3
    1
    3
        Hemoglobin: Grade 0
    2
    1
    2
        Hemoglobin: Grade 1
    1
    0
    0
        Hemoglobin: Grade 2
    0
    0
    1
        Absolute neutrophil count: Grade 0
    2
    1
    0
        Absolute neutrophil count: Grade 1
    1
    0
    1
        Absolute neutrophil count: Grade 3
    0
    0
    1
        Absolute neutrophil count: Grade 4
    0
    0
    1
        Platelets: Grade 0
    3
    1
    2
        Platelets: Grade 3
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine) [5]
    End point description
    The Cmax is the maximum observed plasma concentration. Intent to Treat (ITT) set was defined as all randomized subjects who receive at least 1 dose of study. Here, "99999" indicates that the data was not estimable as only one subject was analyzed in the specified arm.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5
    Notes
    [5] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    1
    3
    Units: nano-gram/milliliter (ng/ml)
    arithmetic mean (standard deviation)
        Day 1
    6184 ± 99999
    7003 ± 3806
        Day 5
    3261 ± 99999
    5112 ± 1665
    No statistical analyses for this end point

    Secondary: Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)

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    End point title
    Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine) [6]
    End point description
    AUC is the area under the plasma concentration-time curve. ITT set was defined as all randomized subjects who receive at least 1 dose of study. Here, "99999" indicates that the data was not estimable as only one subject was analyzed in the specified arm.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5
    Notes
    [6] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    1
    3
    Units: nanogram hour per milliliters (ng*h/ml)
    arithmetic mean (standard deviation)
        Day 1
    12700 ± 99999
    17800 ± 713.9
        Day 5
    11840 ± 99999
    20500 ± 655.7
    No statistical analyses for this end point

    Secondary: Trough Observed Analyte Concentration (C[trough]) of JNJ-63549109 (Metabolite of Lumicitabine)

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    End point title
    Trough Observed Analyte Concentration (C[trough]) of JNJ-63549109 (Metabolite of Lumicitabine) [7]
    End point description
    C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine). ITT set was defined as all randomized subjects who receive at least 1 dose of study Here, "99999" indicates that the data was not estimable as only one subject was analyzed in the specified arm.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 5
    Notes
    [7] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    1
    3
    Units: ng/ml
    arithmetic mean (standard deviation)
        Day 1
    91.16 ± 99999
    187.8 ± 52.97
        Day 5
    189.8 ± 99999
    358.3 ± 37.42
    No statistical analyses for this end point

    Secondary: Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 hours Postdose (C12h)

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    End point title
    Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 hours Postdose (C12h) [8]
    End point description
    C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.
    End point type
    Secondary
    End point timeframe
    12 hours postdose
    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: Endpoint was planned to be analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: ng/ml
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [9] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [10] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Length of Hospital Stay

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    End point title
    Length of Hospital Stay
    End point description
    Length of hospital stay is defined as the time from hospitalization to actual hospital discharge. Randomized or Treated (RT) set was defined as subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the all subjects treated (AST) set. Here ‘99999’ indicates that the subject was not analyzed for the respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Hours
    number (not applicable)
        Subject 1
    143.5
    99999
    99999
        Subject 2
    167.8
    99999
    99999
        Subject 3
    179.4
    99999
    99999
        Subject 4
    99999
    167.8
    99999
        Subject 5
    99999
    99999
    120
        Subject 6
    99999
    99999
    239.5
        Subject 7
    99999
    99999
    149.3
    No statistical analyses for this end point

    Secondary: Number of Subjects Admitted to the Intensive Care Unit (ICU)

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    End point title
    Number of Subjects Admitted to the Intensive Care Unit (ICU)
    End point description
    Number of subjects who were admitted to the ICU was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of ICU Stay

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    End point title
    Duration of ICU Stay
    End point description
    In the event that a subject required ICU, the duration for how long the subject remained in the ICU was reported.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Hours
        number (not applicable)
    Notes
    [11] - No subject was admitted to ICU hence results could not be determined for this end point.
    [12] - No subject was admitted to ICU hence results could not be determined for this end point.
    [13] - No subject was admitted to ICU hence results could not be determined for this end point.
    No statistical analyses for this end point

    Secondary: Number of Subjects who Required Supplemental Oxygen

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    End point title
    Number of Subjects who Required Supplemental Oxygen
    End point description
    The number of subjects who required supplemental oxygen above pre-RSV infection status was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects who Required Non-invasive Mechanical Ventilation Support

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    End point title
    Number of Subjects who Required Non-invasive Mechanical Ventilation Support
    End point description
    The number of subjects who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects who Required Invasive Mechanical Ventilation Support

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    End point title
    Number of Subjects who Required Invasive Mechanical Ventilation Support
    End point description
    The number of subjects who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Supplemental Oxygen

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    End point title
    Duration of Supplemental Oxygen
    End point description
    Duration of supplemental oxygen above pre-RSV infection status was assessed. Population included Randomized or Treated set who received who received supplemental oxygen.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    1
    1
    0 [14]
    Units: Hours
        number (not applicable)
    59.4
    0.5
    Notes
    [14] - No subject received supplemental oxygen hence results could not be determined for this end point.
    No statistical analyses for this end point

    Secondary: Duration of Non-invasive Mechanical Ventilation Support

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    End point title
    Duration of Non-invasive Mechanical Ventilation Support
    End point description
    Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: Hours
        number (not applicable)
    Notes
    [15] - No subject received non-invasive mechanical ventilation support, result was not drawn for endpoint.
    [16] - No subject received non-invasive mechanical ventilation support, result was not drawn for endpoint.
    [17] - No subject received non-invasive mechanical ventilation support, result was not drawn for endpoint.
    No statistical analyses for this end point

    Secondary: Duration of Invasive Mechanical Ventilation Support

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    End point title
    Duration of Invasive Mechanical Ventilation Support
    End point description
    Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: Hours
        number (not applicable)
    Notes
    [18] - No subject received invasive mechanical ventilation support, result was not determined for endpoint.
    [19] - No subject received invasive mechanical ventilation support, result was not determined for endpoint.
    [20] - No subject received invasive mechanical ventilation support, result was not determined for endpoint.
    No statistical analyses for this end point

    Secondary: Time to no Longer Requiring Supplemental Oxygen

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    End point title
    Time to no Longer Requiring Supplemental Oxygen
    End point description
    Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported. Population included Randomized or Treated set who received who received supplemental oxygen.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    1
    1
    0 [21]
    Units: Hours
        number (not applicable)
    59.4
    0.5
    Notes
    [21] - No subject received supplemental oxygen hence results could not be determined for this end point.
    No statistical analyses for this end point

    Secondary: Time to Clinical Stability

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    End point title
    Time to Clinical Stability
    End point description
    Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. As study was terminated early with fewer subjects than planned, collected data could not be summarized. Hence, individual data for each subject was reported. Here ‘99999’ indicates that the subject was not analyzed for respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Hours
    number (not applicable)
        Subject 1
    63.8
    99999
    99999
        Subject 2
    39.5
    99999
    99999
        Subject 3
    191.2
    99999
    99999
        Subject 4
    99999
    63.3
    99999
        Subject 5
    99999
    99999
    71.3
        Subject 6
    99999
    99999
    646.4
        Subject 7
    99999
    99999
    0
    No statistical analyses for this end point

    Secondary: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Subjects who were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms

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    End point title
    Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Subjects who were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms
    End point description
    Time from initiation of study treatment until SpO2 >=93% on room air among subjects who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    Units: Days
        number (not applicable)
    Notes
    [22] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [23] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [24] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Time for Respiratory Rate to Return to Pre-RSV Infection Status

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    End point title
    Time for Respiratory Rate to Return to Pre-RSV Infection Status
    End point description
    Time for the respiratory rate to return to pre-RSV infection status was measured. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. As the study was terminated early with fewer subjects than planned, collected data were not summarized. Hence, individual data for each subject was reported. Here ‘99999’ indicates that the subject was not analyzed for respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Hours
    number (not applicable)
        Subject 1
    0
    99999
    99999
        Subject 2
    39.5
    99999
    99999
        Subject 3
    46.4
    99999
    99999
        Subject 4
    99999
    0
    99999
        Subject 5
    99999
    99999
    71.3
        Subject 6
    99999
    99999
    646.4
        Subject 7
    99999
    99999
    0
    No statistical analyses for this end point

    Secondary: Time for SpO2 to Return to Pre-RSV Infection Status

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    End point title
    Time for SpO2 to Return to Pre-RSV Infection Status
    End point description
    Time for SpO2 to return to pre-RSV infection status was measured. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. As the study was terminated early with fewer subjects than planned, collected data was not summarized. Hence, individual data for each subject was reported. Here ‘99999’ indicates that the subject was not analyzed for respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Hours
    number (not applicable)
        Subject 1
    0
    99999
    99999
        Subject 2
    0
    99999
    99999
        Subject 3
    70
    99999
    99999
        Subject 4
    99999
    33.7
    99999
        Subject 5
    99999
    99999
    0
        Subject 6
    99999
    99999
    0
        Subject 7
    99999
    99999
    0
    No statistical analyses for this end point

    Secondary: Time for Body Temperature to Return To Pre-RSV Infection Status

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    End point title
    Time for Body Temperature to Return To Pre-RSV Infection Status
    End point description
    Time for body temperature to return to pre-RSV infection status was measured. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. As the study was terminated early with fewer subjects than planned, collected data was not summarized. Hence, individual data for each subject was reported. Here ‘99999’ indicates that the subject was not analyzed for respective arm.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Days
    number (not applicable)
        Subject 1
    0
    99999
    99999
        Subject 2
    643.5
    99999
    99999
        Subject 3
    37.4
    99999
    99999
        Subject 4
    99999
    16.7
    99999
        Subject 5
    99999
    99999
    0
        Subject 6
    99999
    99999
    0
        Subject 7
    99999
    99999
    641.6
    No statistical analyses for this end point

    Secondary: Number of Subjects With Acute Otitis Media

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    End point title
    Number of Subjects With Acute Otitis Media
    End point description
    Number of subjects with acute otitis media was reported. Randomized or Treated set was defined as all subjects who were in the Randomized Analysis Set (all randomized subjects with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Signs and Symptoms of RSV Infection

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    End point title
    Duration of Signs and Symptoms of RSV Infection
    End point description
    Duration of signs and symptoms of RSV infection was assessed.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [25]
    0 [26]
    0 [27]
    Units: Hours
        number (not applicable)
    Notes
    [25] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [26] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [27] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)

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    End point title
    Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
    End point description
    The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS questions were answered by means of the following response scale: a lot less than usual, a little less than usual, about as much as usual, a little more than usual, a lot more than usual.
    End point type
    Secondary
    End point timeframe
    Up to 28 Days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [28]
    0 [29]
    0 [30]
    Units: Score on scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [28] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [29] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [30] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    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 over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens. Intention-To-Treat-infected (ITT-i) set was defined as all randomly assigned subjects who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.
    End point type
    Secondary
    End point timeframe
    On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: log10 per milliliters (log10/mL)
    arithmetic mean (standard deviation)
        Day 2
    5.817 ± 2.2087
    6.809 ± 99999
    6.660 ± 0.9732
        Day 3
    5.443 ± 1.4645
    6.000 ± 99999
    5.351 ± 0.5794
        Day 4
    4.674 ± 2.4209
    2.900 ± 99999
    4.190 ± 1.4190
        Day 5
    3.808 ± 1.0049
    5.949 ± 99999
    4.521 ± 1.7506
        Day 6
    3.137 ± 1.9306
    6.514 ± 99999
    4.110 ± 1.6980
        Day 7
    2.994 ± 1.4450
    4.584 ± 99999
    2.754 ± 1.2688
        Day 10
    2.821 ± 1.5950
    1.900 ± 99999
    3.573 ± 0.7610
        Day 14
    1.900 ± 0.0000
    2.900 ± 99999
    1.983 ± 0.1443
        Day 28
    1.900 ± 0.0000
    1.900 ± 00000
    1.900 ± 0.0000
    No statistical analyses for this end point

    Secondary: Peak Viral Load

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    End point title
    Peak Viral Load
    End point description
    Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [31]
    0 [32]
    0 [33]
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [31] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [32] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [33] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Time To Peak Viral Load

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    End point title
    Time To Peak Viral Load
    End point description
    Time to peak viral load was reported.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    Units: Hours
        number (not applicable)
    Notes
    [34] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [35] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [36] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Decline of Viral Load

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    End point title
    Percentage of Subjects with Decline of Viral Load
    End point description
    Percentage of subjects with decline in viral load during treatment as measured by qRT-PCR was reported. ITT-i set was defined as all randomly assigned subjects who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Percentage of subjects
        number (not applicable)
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Time to RSV Ribonucleic Acid (RNA) Being Undetectable

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    End point title
    Time to RSV Ribonucleic Acid (RNA) Being Undetectable
    End point description
    Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [37]
    0 [38]
    0 [39]
    Units: Hours
        number (not applicable)
    Notes
    [37] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [38] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [39] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    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 the undetectable viral load was reported.
    End point type
    Secondary
    End point timeframe
    Up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [40]
    0 [41]
    0 [42]
    Units: Percentage of Subjects
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [40] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [41] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [42] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: AUC of RSV RNA Viral Load From Baseline up to Day 10

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    End point title
    AUC of RSV RNA Viral Load From Baseline up to Day 10 [43]
    End point description
    AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 10
    Notes
    [43] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [44]
    0 [45]
    Units: ng*h/ml
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [44] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [45] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: AUC of RSV RNA Viral Load From Baseline up to Day 14

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    End point title
    AUC of RSV RNA Viral Load From Baseline up to Day 14 [46]
    End point description
    AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 14
    Notes
    [46] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [47]
    0 [48]
    Units: ng*h/ml
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [47] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [48] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: AUC of RSV Viral Load From Baseline Until 1 day (+2 Days) After the Last Dose of Study Drug

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    End point title
    AUC of RSV Viral Load From Baseline Until 1 day (+2 Days) After the Last Dose of Study Drug [49]
    End point description
    AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
    End point type
    Secondary
    End point timeframe
    Baseline Until 1 day (+2 Days) After the Last Dose of Study Drug (approximately up to 10 days)
    Notes
    [49] - 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 analyzed for specified arm only.
    End point values
    Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [50]
    0 [51]
    Units: ng*h/ml
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [50] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [51] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences

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    End point title
    Number of Subjects With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
    End point description
    Number of subjects were assessed for changes in the RSV polymerase L-gene (only if no mutations are seen in the L-gene) and other regions of the RSV genome compared with baseline sequences. Population included randomized or treated set and those who received supplemental oxygen. As study was terminated early with fewer participants than planned, results for this endpoint could not be drawn. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.
    End point type
    Secondary
    End point timeframe
    Baseline up to 28 days
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    3
    1
    3
    Units: Subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Acceptability of the Lumicitabine Formulation as Assessed by Parent(s)/Caregiver(s) electronic clinical outcome assessment (eCOA)

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    End point title
    Acceptability of the Lumicitabine Formulation as Assessed by Parent(s)/Caregiver(s) electronic clinical outcome assessment (eCOA)
    End point description
    Acceptability of the lumicitabine formulation was assessed by parent(s)/caregiver(s) eCOA.
    End point type
    Secondary
    End point timeframe
    Up to Day 6
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [52]
    0 [53]
    0 [54]
    Units: Units on scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [52] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [53] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [54] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Secondary: Palatability of the Lumicitabine Formulation as Assessed by Parent(s)/Caregiver(s) eCOA

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    End point title
    Palatability of the Lumicitabine Formulation as Assessed by Parent(s)/Caregiver(s) eCOA
    End point description
    Palatability (taste and texture) of the lumicitabine formulation was assessed by parent(s)/caregiver(s) eCOA.
    End point type
    Secondary
    End point timeframe
    Up to Day 6
    End point values
    Placebo Lumicitabine 40/20 mg/kg LD/MD Lumicitabine 60/40 mg/kg LD/MD
    Number of subjects analysed
    0 [55]
    0 [56]
    0 [57]
    Units: Units on scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [55] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [56] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    [57] - As study was terminated early with fewer subjects, result for this endpoint could not be determined.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 28 days
    Adverse event reporting additional description
    Safety analysis set was defined as all subjects who received at least 1 dose of study drug, analyzed as treated.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).

    Reporting group title
    60/40 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.

    Reporting group title
    40/20 mg/kg LD/MD
    Reporting group description
    Subjects received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.

    Serious adverse events
    Placebo 60/40 mg/kg LD/MD 40/20 mg/kg LD/MD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo 60/40 mg/kg LD/MD 40/20 mg/kg LD/MD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Diaper
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2017
    This amendment was to remove furosemide, ibuprofen, and trimethoprim/sulfamethoxazole from the list of prohibited moderate/strong inhibitors of organic anion transporter 3. In addition, no food intake information with regard to study drug administration was collected for discharged subjects due to the minimal impact of food intake on trough levels (PK sample at Day 7). Furthermore, it was clarified that leftover samples from nasal swabs and PK testing only (not safety testing) could be used for exploratory biomarker analysis.

    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.
    Only 7 subjects were treated before the study was prematurely terminated. Due to this small number of treated subjects, statistical analysis was not conducted as planned. Hence it was not possible to evaluate the primary or secondary objectives.
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