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Protocol Number53718678RSV2002
NCT Number(ClinicalTrials.gov Identfier)NCT03656510

2018-11-01 - 2021-01-31

Phase II

Recruiting6

ICD-10J21.0

Acute bronchiolitis due to respiratory syncytial virus

ICD-9466.11

Acute bronchiolitis due to respiratory syncytial virus(RSV)

A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Jinn-Li Wang Division of Pediatrics
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林千裕 Division of Pediatrics
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator PO - YEN CHEN Division of Pediatrics
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Chuan Huang Division of Pediatrics
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Hsun Chiu Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Min Huang Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Respiratory Syncytial Virus(RSV) Infection

Objectives

Primary Objective The primary objective is to establish antiviral activity of JNJ-53718678 as measured by RSV viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in children ≥28 days and ≤3 years of age with RSV disease.

Test Drug

JNJ-53718678/Placebo

Active Ingredient

JNJ-53718678/Placebo

Dosage Form

Dosage

23

Endpoints

Primary Outcome Measures :
Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5 [ Time Frame: Baseline through Day 5 ]
RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.


Secondary Outcome Measures :
RSV Viral Load and Change from Baseline Over Time [ Time Frame: Baseline through Day 21 ]
RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14 [ Time Frame: Baseline through Days 3, 8 and 14 ]
RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

Time to Undetectable RSV Viral Load [ Time Frame: Up to 21 days ]
Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Proportion of Participants with Undetectable RSV Viral Load at each timepoint [ Time Frame: Up to 21 days ]
Proportion of participants with undetectable RSV viral load will be reported.

Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) [ Time Frame: Up to 21 days ]
Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Severity of RSV Disease Assessed by PRESORS [ Time Frame: Up to 21 days ]
Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores [ Time Frame: Baseline up to 21 days ]
Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

Change from Baseline in Clinician PRESORS Scores [ Time Frame: Baseline up to 21 days ]
Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

Time to Resolution of RSV Symptoms [ Time Frame: Up to 21 days ]
Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Time to Improvement on Overall Health [ Time Frame: Up to 21 days ]
Time to improvement based on general questions on overall health will be reported.

Proportion of Participants with Improvement or Worsening of RSV Disease [ Time Frame: Up to 21 days ]
Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) [ Time Frame: Up to 21 days ]
Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Proportion of Participants with Vital Sign Abnormalities [ Time Frame: Up to 28 days ]
Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s) [ Time Frame: Up to 28 days ]
Proportion of participants with abnormal body temperature will be reported.

Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up [ Time Frame: Up to 21 days ]
Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.

Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease [ Time Frame: Up to 21 days ]
Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.

Cohort 1: Time to Discharge [ Time Frame: Up to 21 days ]
Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.

Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU) [ Time Frame: Up to 21 days ]
Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.

Cohort 1: Duration of ICU Stay [ Time Frame: Up to 21 days ]
In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.

Cohort 1: Proportion Participants who Require Supplemental Oxygen [ Time Frame: Up to 21 days ]
Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.

Cohort 1: Duration of Supplemental Oxygen [ Time Frame: Up to 21 days ]
Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.

Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support [ Time Frame: Up to 21 days ]
Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.

Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support [ Time Frame: Up to 21 days ]
Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.

Cohort 1: Duration of Non-invasive Ventilator Support [ Time Frame: Up to 21 days ]
Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.

Cohort 1: Duration of Invasive Ventilator Support [ Time Frame: Up to 21 days ]
Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.

Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube [ Time Frame: Up to 21 days ]
Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.

Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator [ Time Frame: Up to 21 days ]
Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.

Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms [ Time Frame: Up to 21 days ]
Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.

Percentage of Participants with Adverse Events [ Time Frame: Up to 28 days ]
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Percentage of Participants with Abnormal Laboratory Findings [ Time Frame: Up to 28 days ]
Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.

Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings [ Time Frame: Up to 21 days ]
Percentage of participants with abnormal ECGs findings will be reported.

Plasma Concentrations of JNJ-53718678 [ Time Frame: Days 1 and 3 ]
Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Medical Resource Utilization [ Time Frame: Up to 28 days ]
Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.

Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s) [ Time Frame: Day 8 ]
Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.

Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences [ Time Frame: Up to 21 days ]
Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.

Inclution Criteria

Inclusion Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1. The subject is a boy or girl ≥28 days and ≤3 years at the time of consent.
2. Each subject’s legally acceptable representative (ie, parent(s)/legal guardian) must sign
an ICF indicating that he or she understands the purpose of and procedures required for
the study, is willing for their child to participate in the study, is willing for their child to
remain in the hospital until at least Day 2 (even if not clinically indicated; Cohort 1
only), and is willing/able to adhere to the lifestyle restrictions specified in the protocol
(see Section 4.3) and study procedures and assessments to be performed by the
parent(s)/caregiver(s) as well as those by the investigator/site staff.
Note: Prior to signing the main consent form for the study, subject’s legally acceptable
representative may specifically allow for the collection and testing of nasal mid -
turbinate swab by signing the pre-screening (diagnostic) ICF. This is not required if
mid-turbinate or nasopharyngeal swabs are collected for diagnostic testing per local
SOC.
3. The subject has been diagnosed with RSV infection using a PCR-based (preferred) or
rapid-antigen-detection assay.
Note: If a subject had a positive similar RSV diagnostic test from another stud y for
which (s)he was otherwise ineligible or a SOC test within 24 hours prior to start of
screening and meets all eligibility criteria for inclusion in this study, this diagnostic test
result can be used for confirmation of eligibility. Randomization should occur within
24 hours after start of screening or within 48 hours after the results of the SOC RSV
positivity test became available, whichever comes first.
Note: If a rapid-antigen-detection assay is used as part of SOC or study-specifically
(with the main study ICF or with the diagnostic ICF having been signed), the sample
used for the RSV diagnostic testing should be sent to the central laboratory for
additional virologic analyses, as applicable.
4. The subject has an acute respiratory illness during which (s)he experienced a period of
apnea
OR
The subject has an acute respiratory illness with at least 1 of the signs/symptoms listed
in each of the following categories within 24 hours prior to start of screening and at
screening, as evaluated by the investigator:
 nasal congestion, rhinorrhea, pharyngitis, or otitis media; AND
 increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal
retractions, grunting, head bobbing, nasal flaring or tachypnea), abnormal breathing
sounds (wheezing, rales or rhonchi), cyanosis or cough; AND
 feeding difficulties, defined as <75% intake of normal food amounts; dehydration;
fever; disturbed sleep or disturbed activity level (irritable/restless/agitated/less responsive).
5. The time of onset of RSV symptoms to the anticipated time of randomization must be
≤5 days. Onset of symptoms is defined as the time of the day (or part of the day if time
of the day cannot be specified) the parent(s)/caregiver(s) became(s) aware of the first
sign and/or symptom consistent with respiratory or systemic/general manifestation of
symptoms of RSV infection. The time of symptom onset has to be assessed as
accurately as possible.
Note: Subjects with symptom onset ≤3 days before randomization must account for at
least 50% of all enrolled subjects in Cohorts 1 and 2, at the time of all different planned
analyses.
6. Except for the RSV-related illness, the subject must be medically stable based on
physical examination, medical history, and vital signs performed at screening. If there
are abnormalities, they must be consistent with the underlying condition (RSV disease
and/or present risk factor[s] for severe RSV disease) in the study population as
evaluated by the investigator. This determination must be recorded in the subject’s
source documents and initialed by the investigator.

Exclusion Criteria

Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating
in the study:
1. The subject is <3 months postnatal age at screening and was born prematurely (ie, <37
weeks and 0 days of gestation).
2. The subject weights <2.4 kg or ≥16.8kg
3. The subject had major surgery within the 28 days prior to randomization or planned
major surgery through the course of the study.
4. The subject has major congenital anomalies or known cytogenetic or metabolic
disorders other than the ones allowed above (see inclusion criterion 4.1).
Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as
these are not considered major anomalies. Subjects with congenital heart disease, cystic
fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
5. The subject is considered by the investigator to be immunocompromised within the past
12 months, whether due to underlying medical condition (eg, malignancy or genetic
disorder other than immunoglobulin A deficiency, or known HIV infection) or medical
therapy (eg, immunomodulators other than corticosteroids for the treatment of
comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
6. The subject has known or clinically suspected hepatitis B or C infection, either acute or
chronic active.
7. The subject has known allergies, hypersensitivity, or intolerance to JNJ-53718678 or to
any of the excipients of the JNJ-53718678 or placebo formulation (refer to the
Investigator’s Brochure).
15
8. The subject is currently participating or planned to participate in another clinical
interventional study, during their participation in this study.
9. The subject is unwilling to undergo or the parent(s)/caregiver(s) is/are unwilling to have
the subject undergoing mid-turbinate nasal swab procedures.
10. The subject has any physical abnormality which limits the ability to collect regular nasal
specimens.
11. The subject is unable to take medications orally or has a known gastrointestinal-related
condition that is considered by the sponsor or investigator to be likely to interfere with
study drug ingestion or absorption.
12. The subject is being treated with extracorporeal membrane oxygenation (Cohort 1 only).
13. The subject is receiving chronic home oxygen therapy at screening.
14. The subject with clinically significant abnormal ECG findings (other than QTcF interval
>500 ms [subjects >0 to ≤2 years] or >450 ms [subjects >2 to 3years]), see exclusion
criterion 15) not consistent with the present risk factor for severe RSV disease (if
applicable) in the study population, as judged by the investigator based on the machine
read results at screening.
15. Confirmed QTcF interval >500 ms (subjects >0 to ≤2 years) or >450 ms (subjects >2 to
3 years) per the machine read (mean) parameter result at screening (based on the
average of the ECGs). Presence of an abnormal QTcF interval should be confirmed by
repeat triplicate ECG recording during screening.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    294 participants

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