EUCTR2019-001509-25-BEActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Janssen Sciences Ireland UC
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Part 1: Observational Stage
- •Each potential participant must satisfy all of the following criteria to be enrolled in the observational stage of the study:
- •1.The infant is =4 months of age at enrollment and asymptomatic for ARI-like symptoms requiring medical intervention at the time of consent to participate in the study.
- •2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) must sign an ICF (observational stage) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the infant to participate in the study and is willing/able to adhere to the study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
- •3.At least 1 parent/caregiver must be able to use the RSV mobile App at home via his/her own Android/iOS electronic device (compatible with RSV mobile App).
- •4.At least 1 parent/caregiver should be of legal consent age (according to local regulation).
- •Part 2: Interventional Stage
- •Each potential participant must satisfy all of the following criteria to be enrolled in the interventional stage of the study:
- •1.The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay.
- •2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an ICF (interventional stage) indicating that he or she understands the purpose of, and procedures required for, the interventional stage of the study and is willing to allow the infant to be treated with JNJ 53718678 or placebo and is willing and able to adhere to the prohibitions and restrictions with regards to the concomitant medication (see Section 6.5), the lifestyle consideration (see Section 5.3), and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
- •Refusal to give consent for the interventional stage does not exclude a participant from continued participation in the observational stage of the study.
- •3.The participant is at least 28 days old at the time of consent.
- •Please see protocol for remaining criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 800
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Part 1: Observational Stage
- •Any potential participant who meets any of the following criteria will be excluded from participating in the observational stage of the study:
- •1.Inclusion in (maternal) RSV vaccine studies or RSV treatment studies.
- •2.During the RSV circulation, the infant is experiencing ARI-like symptoms requiring medical intervention on the day of enrollment.
- •3.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •4.The participant has any physical abnormality which limits the ability to collect regular nasal specimens.
- •5.The participant is receiving chronic home oxygen therapy at enrollment.
- •Part 2: Interventional Stage
- •Any potential participant who meets any of the following criteria will be excluded from participating in the interventional stage of the study:
- •1.The participant has major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed below.
- •Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as these are not considered major anomalies. Participants with congenital heart disease, cystic fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
- •2.The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or known HIV infection) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
- •3.The participant has known or clinically suspected hepatitis B or C infection, either acute or chronic active.
- •Please see protocol for remaining criteria.
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