Clinical trial NCT04068792: A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Viruses
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 22
Sex: ALL
Minimum age (years): 28
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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:

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

Primary outcomes:
measure: Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
timeFrame: Baseline (Day 1) up to Day 5
Secondary outcomes:
measure: RSV Viral Load Over Time
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
measure: Change From Baseline in RSV Viral Load Over Time
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
measure: RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14
timeFrame: Baseline through Days 3, 8, and 14
measure: Time to Undetectable RSV Viral Load
timeFrame: Up to 21 days
measure: Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
timeFrame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21
measure: Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
timeFrame: Baseline, Days 3, 5, 8, 14, and 21
measure: Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
timeFrame: Baseline, Day 3, 5, 8, 14, 21
measure: Change From Baseline in Clinician PRESORS Score
timeFrame: Baseline, Day 3, 5, 8, 14, 21
measure: Time to Resolution of RSV Symptoms
timeFrame: Up to 21 days
measure: Time to Improvement on Overall Health
timeFrame: Up to 21 days
measure: Percentage of Participants With Worsening or Improvement of RSV Disease
timeFrame: On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)
timeFrame: Up to 21 days
measure: Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up
timeFrame: Up to Day 31
measure: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 31
measure: Percentage of Participants With Abnormal Chemistry Laboratory Findings
timeFrame: Up to Day 31
measure: Percentage of Participants With Abnormal Urinalysis Laboratory Findings
timeFrame: Up to Day 31
measure: Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
timeFrame: Up to Day 31
measure: Percentage of Participants With Vital Sign Abnormalities
timeFrame: Up to Day 31
measure: Plasma Concentrations of JNJ-53718678
timeFrame: Day 1 and Day 3
Other outcomes:
Locations:
city: Tucumán
country: Argentina
facility: Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Panama
country: Panama
facility: Cevaxin 24 de diciembre
city: Panama
country: Panama
facility: Cevaxin Avenida Mexico
city: Republica De Panama
country: Panama
facility: Cevaxin La Chorrera
city: Hsinchu
country: Taiwan
facility: Hsinchu MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Department of Pediatrics, MacKay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital- Linkou
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: