Status:
COMPLETED
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Respiratory Syncytial Viruses
Eligibility:
All Genders
28-4 years
Phase:
PHASE2
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 antivir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04068792
Start Date
October 10 2019
End Date
May 15 2021
Last Update
February 4 2025
Active Locations (10)
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1
Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes
San Miguel de Tucumán, Argentina
2
UZ Antwerpen
Edegem, Belgium, 2650
3
Cevaxin 24 de diciembre
Panama City, Panama, 000000
4
Cevaxin Avenida Mexico
Panama City, Panama, 000000