A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

May 12, 2022 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Tucumán, Argentina
        • Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
  • Panama
      • Panama, Panama, 000000
        • Cevaxin 24 de diciembre
      • Panama, Panama, 000000
        • Cevaxin Avenida Mexico
      • Republica De Panama, Panama, 000000
        • Cevaxin La Chorrera
  • Taiwan
      • Hsinchu, Taiwan, 30071
        • Hsinchu MacKay Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10449
        • Department of Pediatrics, MacKay Memorial Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital- Linkou
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St George's University Hosptial NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 4 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Part 1-Observational Phase
Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV [-] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV [+] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients).
Other: RSV Mobile Application
Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.
EXPERIMENTAL: Part 2-Interventional Phase
Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.
Drug: Placebo
Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.
Drug: JNJ-53718678 2.5 mg/kg
JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.
Drug: JNJ-53718678 3 mg/kg
JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.
Drug: JNJ-53718678 4.5 mg/kg
JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
Time Frame: Baseline (Day 1) up to Day 5
RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
Baseline (Day 1) up to Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSV Viral Load Over Time
Time Frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
RSV viral load actual values over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
Change From Baseline in RSV Viral Load Over Time
Time Frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21
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: Baseline through Days 3, 8, and 14
RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens.
Baseline through Days 3, 8, and 14
Time to Undetectable RSV Viral Load
Time Frame: Up to 21 days
Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post-baseline time point at which the virus is confirmed undetectable. A confirmed undetectable sample is defined as the first of at least two consecutive samples that are undetectable. The last obtained sample for a participant, if undetectable, is considered confirmed.
Up to 21 days
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Time Frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21
Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported.
Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Time Frame: Baseline, Days 3, 5, 8, 14, and 21
The severity of signs and symptoms of RSV infection (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) were assessed by the PRESORS. PRESORS is a questionnaire by parent(s)/caregiver(s) recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Baseline, Days 3, 5, 8, 14, and 21
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Time Frame: Baseline, Day 3, 5, 8, 14, 21
PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Baseline, Day 3, 5, 8, 14, 21
Change From Baseline in Clinician PRESORS Score
Time Frame: Baseline, Day 3, 5, 8, 14, 21
Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 10-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Baseline, Day 3, 5, 8, 14, 21
Time to Resolution of RSV Symptoms
Time Frame: Up to 21 days
Time to resolution from first dose of study drug until the first time of resolution of all RSV Symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.
Up to 21 days
Time to Improvement on Overall Health
Time Frame: Up to 21 days
Time to improvement based on general questions on overall health was reported. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.
Up to 21 days
Percentage of Participants With Worsening or Improvement of RSV Disease
Time Frame: On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
Percentage of participants with worsening or improvement of RSV disease based on general questions on overall health was reported. Improvement is defined improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.
On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
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) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level.
Up to 21 days
Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up
Time Frame: Up to Day 31
Percentage of participants who require (re)hospitalization during treatment and follow-up were reported.
Up to Day 31
Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to Day 31
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.
Up to Day 31
Percentage of Participants With Abnormal Chemistry Laboratory Findings
Time Frame: Up to Day 31
Percentage of participants with abnormal chemistry laboratory findings (alanine aminotransferase [ALT; Grade 1 and 4], aspartate aminotransferase [AST; Grade 1], and Hyperkalemia [Grade 1 and 2]) were reported based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.
Up to Day 31
Percentage of Participants With Abnormal Urinalysis Laboratory Findings
Time Frame: Up to Day 31
Percentage of participants with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.
Up to Day 31
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
Time Frame: Up to Day 31
Percentage of participants with abnormal ECGs findings were reported. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), change from baseline for QTcB Interval ([30; 60] ms, and greater than [>] 60 ms), and for QTcF Interval ([30; 60] ms, and >60 ms).
Up to Day 31
Percentage of Participants With Vital Sign Abnormalities
Time Frame: Up to Day 31
Percentage of participants with vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities (abnormally low [ABL] and abnormally high [ABH]) were reported.
Up to Day 31
Plasma Concentrations of JNJ-53718678
Time Frame: Day 1 and Day 3
No data was collected for pharmacokinetic (PK) analysis due to small sample size. Hence, no results are reported.
Day 1 and Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2019

Primary Completion (ACTUAL)

May 15, 2021

Study Completion (ACTUAL)

May 15, 2021

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108647
  • 2019-001509-25 (EUDRACT_NUMBER)
  • 53718678RSV2006 (OTHER: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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