問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number53718678RSV2006
NCT Number(ClinicalTrials.gov Identfier)NCT04068792

2019-09-07 - 2021-01-26

Phase II

Terminated4

ICD-10B97.4

Respiratory syncytial virus as the cause of diseases classified elsewhere

ICD-9079.6

Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site

A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chi-Long Chen Division of Pediatrics
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chi Hsin Division of Pediatrics
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 林千裕 Division of Pediatrics
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Respiratory Syncytial Virus Infections

Objectives

The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.

Test Drug

JNJ-53718678

Active Ingredient

JNJ-53718678-ZCL

Dosage Form

suspension

Dosage

23

Endpoints

Primary Outcome Measures :

Part 2: RSV Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5 [ Time Frame: On the day of diagnosis (Baseline) through Day 5 of interventional stage ]
Respiratory Syncytial Virus (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 quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.


Secondary Outcome Measures :

Part 1: Total Respiratory Symptom Score Over Time [ Time Frame: Up to 21 Days of observational stage ]
Total Respiratory Symptom Score over time will be captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive participants that do not enter in the interventional stage.

Part 1: Change from Baseline in Clinician Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Scores [ Time Frame: On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stage ]
Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician 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.

Part 1: RSV Viral Load [ Time Frame: Pre-diagnostic phase: Within 24hrs of Observation Day 1 ]
RSV Viral load during pre-diagnostic phase will be determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens.

Part 1: RSV Viral Load Kinetics from Day 1 to Day 8 [ Time Frame: On the day of diagnosis (Baseline) through Day 8 of observational stage ]
RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) will be measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens.

Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time [ Time Frame: On the day of diagnosis (Baseline) up to 21 Days of the observational stage ]
Change from baseline in Parent(s)/Caregiver(s) PRESORS scores (worsening or improvement) will be reported.

Part 2: RSV Viral Load and Change from Baseline Over Time [ Time Frame: On the day of diagnosis (Baseline) through Day 21 of interventional stage ]
RSV viral load and change from baseline over time will be measured by qRT-PCR assay in mid-turbinate nasal swab specimens.

Part 2: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14 [ Time Frame: On the day of diagnosis (Baseline) through Days 3, 8 and 14 of interventional stage ]
RSV viral load AUC will be determined by qRT-PCR assay in mid-turbinate nasal swab specimens.

Part 2: Time to Undetectable RSV Viral Load [ Time Frame: Up to 21 days of interventional stage ]
Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

Part 2: Percentage of Participants with Undetectable RSV Viral Load at each timepoint [ Time Frame: Up to 21 days of interventional stage ]
Percentage of participants with undetectable RSV viral load will be reported.

Part 2: Duration of Signs and Symptoms of RSV Disease Assessed by the PRESORS [ Time Frame: Up to 21 days of interventional stage ]
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).

Part 2: Severity of RSV Disease Assessed by PRESORS [ Time Frame: Up to 21 days of interventional stage ]
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).

Part 2: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores [ Time Frame: On the day of diagnosis (Baseline) up to 21 days of interventional stage ]
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.

Part 2: Change from Baseline in Clinician PRESORS Scores [ Time Frame: On the day of diagnosis (Baseline) up to 21 days of interventional stage ]
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.

Part 2: Time to Resolution of RSV Symptoms [ Time Frame: Up to 21 days of interventional stage ]
Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

Part 2: Time to Improvement on Overall Health [ Time Frame: Up to 21 days of interventional stage ]
Time to improvement based on general questions on overall health will be reported.

Part 2: Percentage of Participants with Improvement or Worsening of RSV Disease [ Time Frame: Up to 21 days of interventional stage ]
Percentage of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

Part 2: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) [ Time Frame: Up to 21 days of interventional stage ]
Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

Part 2: Percentage of Participants with Vital Sign Abnormalities [ Time Frame: Up to 28 days of interventional stage ]
Percentage of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

Part 2: Percentage of Participants who Require (re)Hospitalization During Treatment and Follow-up [ Time Frame: Up to 28 days of interventional stage ]
Percentage of participants who require (re)hospitalization during treatment and follow-up will be reported.

Part 2: Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 28 days of interventional stage ]
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.

Part 2: Percentage of Participants with Abnormal Laboratory Findings [ Time Frame: Up to 28 days of interventional stage ]
Percentage of participants with abnormal laboratory findings (hematology, biochemistry, urinalysis) will be reported.

Part 2: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings [ Time Frame: Up to 28 days of interventional stage ]
Percentage of participants with abnormal ECGs findings will be reported.

Part 2: Plasma Concentrations of JNJ-53718678 [ Time Frame: Day 1 and Day 3 of interventional stage ]
Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

Inclution Criteria

Inclusion Criteria:

Part 1: Observational Stage

The infant is less than or equal to (<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Part 2: Interventional Stage

The infant is 28 days and if prematurely born infant (that is [i.e.], less than [<] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
The participant weighs more than 2.4 kilogram (kg)
The participant has an acute respiratory illness as evaluated by the investigator
Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection

Exclusion Criteria

Exclusion Criteria:

Part 1: Observational Stage

The participant has any physical abnormality which limits the ability to collect regular nasal specimens
The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)

Part 2: Interventional Stage

The participant is <3 months postnatal age at screening and was born prematurely (i.e., <37 weeks and 0 days of gestation) or if the participant weights <2.4 kg
The participant has a QT interval with Fridericia's correction (QTcF) greater than (>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization

The Estimated Number of Participants

  • Taiwan

    180 participants

  • Global

    1300 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB