Acute Respiratory Tract Infection due to RSV MedDRA version: 20.1 Level: LLT Classification code 10066740 Term: Acute respiratory tract infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: Observational Stage •To evaluate the onset and evolution of clinical symptoms of pediatric RSV disease •To evaluate the relationship between viral load and clinical symptoms at early diagnosis of pediatric RSV disease Part 2: Interventional Stage The primary objective is to evaluate antiviral activity of JNJ-53718678 as measured by RSV viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in an early intervention setting in infants (=4 months of age at enrollment) recruited from a birth cohort. ;Secondary Objective: The secondary objectives are to assess: •the impact of treatment with JNJ-53718678 on the clinical course of RSV infection •the safety and tolerability of JNJ-53718678 after repeated oral doses •the pharmacokinetics (PK) of JNJ-53718678 after repeated oral doses ;Primary end point(s): Part 1: Observational Stage •the total score, over time, of respiratory symptoms as captured by the RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV(+) participants that do not enter in the interventional stage •the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) scores by the clinician (clinician PRESORS) on the day of RSV diagnosis •RSV viral load kinetics during the pre-diagnostic phase •RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) •the PRESORS scores by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) over time Part 2: Interventional Stage The primary efficacy endpoint is the RSV viral load area under the curve (AUC) from immediately prior to first dose of study medication through Day 5 derived from the RSV viral load as measured by a qRT PCR assay in nasal swabs. ;Timepoint(s) of evaluation of this end point: Part 1- Observational stage: 1.From Enrollment up to RSV mobile app alert 2.Day of Diagnosis 3.Day 1 to 8 4.Day 1 to 8 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of the interventional stage can be summarized as follows: •virologic parameters derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs including: -RSV viral load and change from baseline (start of study medication) over time -RSV viral load AUC from immediately prior to first dose of study medication (baseline) through Day 3, Day 8, and Day 14 -time to undetectable RSV viral load -proportion of participants with undetectable RSV viral load at each time point throughout the study •clinical course related endpoints: the following endpoints will be based on the PRESORS assessed throughout the interventional stage of the study by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) and by the investigator (clinician PRESORS) during scheduled visits: •duration and severity of signs and symptoms of RSV disease assessed throughout the study by parent(s)/caregiver(s) PRESORS •change from baseline in parent(s)/caregiver(s) PRESORS (worsening or improvement) •change from baseline in clinician PRESORS (worsening or improvement) •time to resolution (ie, to none or mild) of RSV symptoms •time to improvement based on general questions on overall health •proportion of participants with improvement or worsening of RSV disease based on general questions on overall health on each study day from screening till Day 21 •time to return to pre-RSV health as rated by the parent(s)/caregiver(s) respiratory rate, heart rate, body temperature, and peripheral capillary oxygen saturation (SpO2) over time as measured during scheduled visits need for (re)hospitalization during treatment and follow-up •safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), and vital signs, throughout the interventional stage of the study •PK parameters of JNJ-53718678, as determined by population PK (popPK) model | — |
Countries
Argentina, Belgium, Panama, Taiwan, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed