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A 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

Primary Purpose

Respiratory Syncytial Viruses

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lumicitabine
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Viruses

Eligibility Criteria

28 Days - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
  • Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria)
  • Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection
  • With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participant's gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted
  • The participant's estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participant's age

Exclusion Criteria:

  • Participants who are not expected to survive for more than 48 hours
  • Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
  • Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection
  • Participants being treated with extracorporeal membrane oxygenation
  • Participant receiving chronic oxygen therapy at home prior to admission
  • Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route)

Sites / Locations

  • MemorialCare Research Miller Children's and Women's Hospital Long Beach
  • The Children's Mercy Hospital
  • Jacobi Medical Center
  • SUNY Upstate Medical University
  • West Virginia University
  • American Family Children's Hospital
  • Huderf
  • McMaster Children's Hospital
  • Heim Pal Gyermekkorhaz, Borgyogyaszati Osztaly
  • Velkey László Gyermekegészségügyi Központ
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • National Hospital Organization Fukuoka Hospital
  • Fukuoka Children's Hospital
  • National Hospital Organization Fukuyama Medical Center
  • Fukuyama City Hospital
  • JA Hiroshima General Hospital
  • Hirosaki National Hospital
  • National Hospital Organization Kanazawa Medical Center
  • National Hospital Organization Kokura Medical Center
  • National Hospital Organization Niigata National Hospital
  • NHO Beppu Medical Center
  • Nakano Children's Hospital
  • Takatsuki General Hospital
  • Ota Memorial Hospital
  • NHO Saitama National Hospital
  • Gunma Children's Medical Center
  • Shikoku Medical Center for Children and Adults
  • Plejady Medical Center
  • Specialistic Hospital Center for Mother and Child

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Regimen A (Low-Dose Lumicitabine)

Regimen B (High-Dose Lumicitabine)

Regimen C (Placebo)

Arm Description

Participants will receive a single 40 milligram per kilogram (mg/kg) loading dose (LD) (Dose 1) followed by nine 20 mg/kg maintenance doses (MDs) (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.

Participants will receive a single 60 mg/kg LD (Dose 1) followed by nine 40 mg/kg MDs (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.

Participants will receive either a single 40 mg/kg placebo LD (Dose 1) followed by nine 20 mg/kg maintenance dose (MDs) (Doses 2 to 10) of placebo twice daily or single 60 mg/kg placebo LD (Dose 1) followed by nine 40 mg/kg placebo MDs (Doses 2 to 10), twice daily up to Day 5/6.

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.

Secondary Outcome Measures

Number of Participants With Emergent Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant 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. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.
Number of Participants With Clinically Significant Physical Examinations Abnormalities
The number of participants 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.
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
The number of participants 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 reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.
Number of Participants With Electrocardiogram (ECG) Abnormalities
The number of participants with ECG (QT, and QTc intervals) abnormalities reported.
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).
Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).
Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
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).
Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)
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.
Length of Hospital Stay
Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.
Number of Participants Admitted to the Intensive Care Unit (ICU)
Number of participants who were admitted to the ICU was reported.
Duration of ICU Stay
In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.
Number of Participants Who Required Supplemental Oxygen
The number of participants who required supplemental oxygen above pre-RSV infection status was reported.
Number of Participants Who Required Non-invasive Mechanical Ventilation Support
The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.
Number of Participants Who Required Invasive Mechanical Ventilation Support
The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.
Duration of Supplemental Oxygen
Duration of supplemental oxygen above pre-RSV infection status was assessed.
Duration of Non-invasive Mechanical Ventilation Support
Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
Duration of Invasive Mechanical Ventilation Support
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.
Time to no Longer Requiring Supplemental Oxygen
Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.
Time to Clinical Stability
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.
Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms
Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Time for the respiratory rate to return to pre-RSV infection status was measured.
Time for SpO2 to Return to Pre-RSV Infection Status
Time for SpO2 to return to pre-RSV infection status was measured.
Time for Body Temperature to Return To Pre-RSV Infection Status
Time for body temperature to return to pre-RSV infection status was measured.
Number of Participants With Acute Otitis Media
Number of participants with acute otitis media was reported.
Duration of Signs and Symptoms of RSV Infection
Duration of signs and symptoms of RSV infection was assessed.
Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).
RSV Viral Load Over Time
RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Peak Viral Load
Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Time To Peak Viral Load
Time to peak viral load was reported.
Percentage of Participants With Decline of Viral Load
Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.
Time to RSV Ribonucleic Acid (RNA) Being Undetectable
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.
Percentage of Participants With Undetectable RSV Viral Load
Percentage of participants with the undetectable viral load was reported.
AUC of RSV RNA Viral Load From Baseline up to Day 10
AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
AUC of RSV RNA Viral Load From Baseline up to Day 14
AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug
AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.
Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)
Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).

Full Information

First Posted
October 16, 2017
Last Updated
December 13, 2019
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03333317
Brief Title
A 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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine in hospitalized infants and children who are 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).
Detailed Description
RSV is a leading cause of lower respiratory tract disease in infants. Most infants and children who get RSV recover fully after 1-2 weeks, but RSV infection can sometimes worsen and may lead to hospitalization and admission into an intensive care unit. The main purpose of this study is to learn how well the study drug (lumicitabine, also known as JNJ-64041575 or ALS-008176) works, how the human body handles the study drug, which dose of the study drug is effective for treatment of RSV infection in infants/children and how safe it is compared to a placebo (placebo looks just like lumicitabine [given in same way] but has no effect against RSV). Approximately up to 180 participants aged between 28 days to 36 months and hospitalized with RSV infection will take part in this world-wide study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Viruses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A (Low-Dose Lumicitabine)
Arm Type
Experimental
Arm Description
Participants will receive a single 40 milligram per kilogram (mg/kg) loading dose (LD) (Dose 1) followed by nine 20 mg/kg maintenance doses (MDs) (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.
Arm Title
Regimen B (High-Dose Lumicitabine)
Arm Type
Experimental
Arm Description
Participants will receive a single 60 mg/kg LD (Dose 1) followed by nine 40 mg/kg MDs (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.
Arm Title
Regimen C (Placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive either a single 40 mg/kg placebo LD (Dose 1) followed by nine 20 mg/kg maintenance dose (MDs) (Doses 2 to 10) of placebo twice daily or single 60 mg/kg placebo LD (Dose 1) followed by nine 40 mg/kg placebo MDs (Doses 2 to 10), twice daily up to Day 5/6.
Intervention Type
Drug
Intervention Name(s)
Lumicitabine
Other Intervention Name(s)
ALS-008176, JNJ-64041575
Intervention Description
Participants will receive oral administration of lumicitabine.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive oral administration of matching placebo.
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Description
AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
Time Frame
Day 1 to 7: Predose, 0.25 and 2 hours postdose
Secondary Outcome Measure Information:
Title
Number of Participants With Emergent Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant 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. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.
Time Frame
Up to 28 days
Title
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Description
The number of participants 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.
Time Frame
Up to 28 days
Title
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Description
The number of participants 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 reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.
Time Frame
Up to 28 days
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
The number of participants with ECG (QT, and QTc intervals) abnormalities reported.
Time Frame
Up to 28 days
Title
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Description
Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.
Time Frame
Up to 28 days
Title
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Description
Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).
Time Frame
Day 1 and Day 5
Title
Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
Description
AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).
Time Frame
Day 1 and Day 5
Title
Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
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).
Time Frame
Day 1 and Day 5
Title
Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)
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.
Time Frame
12 hours postdose
Title
Length of Hospital Stay
Description
Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.
Time Frame
Up to 28 days
Title
Number of Participants Admitted to the Intensive Care Unit (ICU)
Description
Number of participants who were admitted to the ICU was reported.
Time Frame
Up to 28 days
Title
Duration of ICU Stay
Description
In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.
Time Frame
Up to 28 days
Title
Number of Participants Who Required Supplemental Oxygen
Description
The number of participants who required supplemental oxygen above pre-RSV infection status was reported.
Time Frame
Up to 28 days
Title
Number of Participants Who Required Non-invasive Mechanical Ventilation Support
Description
The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.
Time Frame
Up to 28 days
Title
Number of Participants Who Required Invasive Mechanical Ventilation Support
Description
The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.
Time Frame
Up to 28 days
Title
Duration of Supplemental Oxygen
Description
Duration of supplemental oxygen above pre-RSV infection status was assessed.
Time Frame
Up to 28 days
Title
Duration of Non-invasive Mechanical Ventilation Support
Description
Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
Time Frame
Up to 28 days
Title
Duration of Invasive Mechanical Ventilation Support
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.
Time Frame
Up to 28 days
Title
Time to no Longer Requiring Supplemental Oxygen
Description
Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.
Time Frame
Up to 28 days
Title
Time to Clinical Stability
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.
Time Frame
Up to 28 days
Title
Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms
Description
Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
Time Frame
Up to 28 days
Title
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Description
Time for the respiratory rate to return to pre-RSV infection status was measured.
Time Frame
Up to 28 days
Title
Time for SpO2 to Return to Pre-RSV Infection Status
Description
Time for SpO2 to return to pre-RSV infection status was measured.
Time Frame
Up to 28 days
Title
Time for Body Temperature to Return To Pre-RSV Infection Status
Description
Time for body temperature to return to pre-RSV infection status was measured.
Time Frame
Up to 28 days
Title
Number of Participants With Acute Otitis Media
Description
Number of participants with acute otitis media was reported.
Time Frame
Up to 28 days
Title
Duration of Signs and Symptoms of RSV Infection
Description
Duration of signs and symptoms of RSV infection was assessed.
Time Frame
Up to 28 days
Title
Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Description
The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).
Time Frame
Up to 28 days
Title
RSV Viral Load Over Time
Description
RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Time Frame
On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28
Title
Peak Viral Load
Description
Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Time Frame
Up to 28 days
Title
Time To Peak Viral Load
Description
Time to peak viral load was reported.
Time Frame
Up to 28 days
Title
Percentage of Participants With Decline of Viral Load
Description
Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.
Time Frame
Up to 28 days
Title
Time to RSV Ribonucleic Acid (RNA) Being Undetectable
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.
Time Frame
Up to 28 days
Title
Percentage of Participants With Undetectable RSV Viral Load
Description
Percentage of participants with the undetectable viral load was reported.
Time Frame
Up to 28 days
Title
AUC of RSV RNA Viral Load From Baseline up to Day 10
Description
AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
Time Frame
Baseline up to Day 10
Title
AUC of RSV RNA Viral Load From Baseline up to Day 14
Description
AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Time Frame
Baseline up to Day 14
Title
AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug
Description
AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Time Frame
Baseline Until 1 Day after the last dose of study drug (up to 10 days)
Title
Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Description
Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.
Time Frame
Baseline up to 28 days
Title
Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)
Description
Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).
Time Frame
Up to Day 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria) Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participant's gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted The participant's estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participant's age Exclusion Criteria: Participants who are not expected to survive for more than 48 hours Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection Participants being treated with extracorporeal membrane oxygenation Participant receiving chronic oxygen therapy at home prior to admission Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
MemorialCare Research Miller Children's and Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
American Family Children's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Huderf
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L85 4K1
Country
Canada
Facility Name
Heim Pal Gyermekkorhaz, Borgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Velkey László Gyermekegészségügyi Központ
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
National Hospital Organization Fukuoka Hospital
City
Fukuoka-shi
ZIP/Postal Code
811-1394
Country
Japan
Facility Name
Fukuoka Children's Hospital
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
National Hospital Organization Fukuyama Medical Center
City
Fukuyama
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
JA Hiroshima General Hospital
City
Hatsukaichi
ZIP/Postal Code
738-8503
Country
Japan
Facility Name
Hirosaki National Hospital
City
Hirosaki
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
National Hospital Organization Kokura Medical Center
City
Kitakyushu
ZIP/Postal Code
802-8533
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Facility Name
NHO Beppu Medical Center
City
Oita
ZIP/Postal Code
874-0011
Country
Japan
Facility Name
Nakano Children's Hospital
City
Osaka
ZIP/Postal Code
535-0022
Country
Japan
Facility Name
Takatsuki General Hospital
City
Osaka
ZIP/Postal Code
569-1192
Country
Japan
Facility Name
Ota Memorial Hospital
City
Ota
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
NHO Saitama National Hospital
City
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
Gunma Children's Medical Center
City
Shibukawa
ZIP/Postal Code
377-8577
Country
Japan
Facility Name
Shikoku Medical Center for Children and Adults
City
Zentsuji
ZIP/Postal Code
765-8507
Country
Japan
Facility Name
Plejady Medical Center
City
Malopolska
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Specialistic Hospital Center for Mother and Child
City
Poznań
ZIP/Postal Code
60-595
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

A 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

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