Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus Infections
In brief
The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants \[Cohort 1\] or outpatients \[Cohort 2\]).
Key facts
- Study ID
- NCT03656510
- Run by
- Janssen Research & Development, LLC
- People needed
- 246
- Starts
- 2018-11-29
- Expected to finish
- 2022-04-18
- Last updated by the study team
- 2025-02-04
Who can join
Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Informed consent form (ICF) must be given
- Laboratory diagnosis of respiratory syncytial virus (RSV) infection
- The participant has an acute respiratory illness
- The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (<=) 5 days
- 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 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection
You may not qualify if…
- The participant is less than (<) 3 months postnatal age at screening and was born prematurely (i.e, <37 weeks and 0 days of gestation) OR if the participant weighs <2.4 kilogram (kg) or greater than (>) 16.8 kg
- Participant is considered by the investigator to be immunocompromised within the past 12 months
- Participant unwilling or unable to undergo mid-turbinate nasal swab procedures
- Participant is receiving chronic home oxygen therapy at screening
- Participant has other clinically significant abnormal electrocardiogram (ECG) findings 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 ECG results at screening
- The participant has a QTcF interval greater than (>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening
Where it is running
- FOMAT Medical Research — Ventura, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Elite Clinical Trials — Blackfoot, Idaho, United States
- Saltzer Medical Group — Nampa, Idaho, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Craig A. Spiegel, MD — Bridgeton, Missouri, United States
- SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) — Syracuse, New York, United States
- Santiago Reyes, MD — Oklahoma City, Oklahoma, United States
- Coastal Pediatric Research — Summerville, South Carolina, United States
- Sanford Health — Sioux Falls, South Dakota, United States
- Children's Hospital of Richmond at VCU — Richmond, Virginia, United States
- West Virginia University — Morgantown, West Virginia, United States
- Hospital Italiano Regional Del Sur — Bahía Blanca, Argentina
- Fundación Respirar — Buenos Aires, Argentina
- Hospital Central Militar Cirujano Mayor Dr Cosme Argerich — Buenos Aires, Argentina
- CEMIC (Centro de Educación Médica e Investigaciones Clínicas) — City of Buenos Aires, Argentina
- Hospital Pedro de Elizalde — City of Buenos Aires, Argentina
- Hospital Italiano de La Plata — Ciudad de La Plata, Argentina
- Hospital Universitario Austral — Pilar, Argentina
- Hospital del Niño Jesús — San Miguel de Tucumán, Argentina
- Clinica Mayo de UMCB — San Miguel de Tucumán, Argentina
- ULB Hôpital Erasme — Anderlecht, Belgium
- UZ Antwerpen — Edegem, Belgium
- Madera Family Medical Group — Madera, California, United States
Full record on ClinicalTrials.gov
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