At a glance
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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
In Brief
A Phase 2 clinical trial evaluating RSV Mobile Application, Placebo, and 3 other interventions for Respiratory Syncytial Viruses. Completed, enrolled 22 participants across 10 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.
JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.
JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.