Phase 2
N=22
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Respiratory Syncytial Viruses
Bottom Line
View on ClinicalTrials.gov: NCT04068792 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Jun 2022
Primary outcome: Primary: Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) — 26.13; 25.10 log10 copies*day per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RSV Mobile Application (Other); Placebo (Drug); JNJ-53718678 2.5 mg/kg (Drug); JNJ-53718678 3 mg/kg (Drug); JNJ-53718678 4.5 mg/kg (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) |
26.13; 25.10 | — |
| SECONDARY RSV Viral Load Over Time |
7.744; 7.477; 7.748; 6.613; 6.415; 6.277 | — |
| SECONDARY Change From Baseline in RSV Viral Load Over Time |
0.022; -0.797; -1.329; -1.293; -2.002; -1.857 | — |
| SECONDARY RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14 |
14.44; 13.70; 39.20; 35.11 | — |
| SECONDARY Time to Undetectable RSV Viral Load |
500.1; 391.4 | — |
| SECONDARY Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study |
0; 0; 0; 14.3; 9.1; 11.1 | — |
| SECONDARY Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) |
0.92; 0.56; 0.98; 0.60; 0.65; 0.37 | — |
| SECONDARY Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores |
0.01; -0.02; -0.27; -0.26; -0.42; -0.39 | — |
| SECONDARY Change From Baseline in Clinician PRESORS Score |
0.03; 0.01; -0.32; -0.04; -0.36; -0.16 | — |
| SECONDARY Time to Resolution of RSV Symptoms |
194.00; 118.60 | — |
| SECONDARY Time to Improvement on Overall Health |
188.3; 199.7 | — |
| SECONDARY Percentage of Participants With Worsening or Improvement of RSV Disease |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s) |
— | — |
| SECONDARY Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up |
0; 0 | — |
| SECONDARY Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability |
27.3; 27.3 | — |
| SECONDARY Percentage of Participants With Abnormal Chemistry Laboratory Findings |
9.1; 0; 9.1; 0; 9.1; 18.2 | — |
| SECONDARY Percentage of Participants With Abnormal Urinalysis Laboratory Findings |
0; 25.0 | — |
| SECONDARY Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings |
20.0; 9.1; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Vital Sign Abnormalities |
9.1; 0; 0; 0; 9.1; 0 | — |
| SECONDARY Plasma Concentrations of JNJ-53718678 |
— | — |
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 ( ) 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
Data sourced from ClinicalTrials.gov (NCT04068792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.