A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Viruses

Treatments: Drug: JNJ-53718678 3 mg/kg; Other: RSV Mobile Application; Drug: JNJ-53718678 2.5 mg/kg; Drug: JNJ-53718678 4.5 mg/kg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04068792

CR108647

2019-001509-25 (EudraCT Number)

53718678RSV2006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 28 days to 4 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Part 1-Observational Phase

Other group

Description:

Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV \[-\] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV \[+\] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients).

Treatment:

Other: RSV Mobile Application

Part 2-Interventional Phase

Experimental group

Description:

Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to \[\>=\] 28 days and less than \[\<\] 3 months): 2.5 milligram per kilogram \[mg/kg\]; for Age Group 2 (\>=3 and \<6 months): 3 mg/kg and for Age Group 3 (\>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.

Treatment:

Drug: Placebo

Drug: JNJ-53718678 4.5 mg/kg

Drug: JNJ-53718678 2.5 mg/kg

Drug: JNJ-53718678 3 mg/kg