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

NCT04068792 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1086472019-001509-2553718678RSV2006
• Study Type: interventional
• Target: 22
• Locations: 5 countries
• Sites: 10

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 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.

Conditions

Respiratory Syncytial Viruses

Outcome Measures

Primary Outcomes (1)

• Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])

  RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.

  Baseline (Day 1) up to Day 5

Secondary Outcomes (19)

• RSV Viral Load Over Time

  Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21

• Change From Baseline in RSV Viral Load Over Time

  Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21

• RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

  Baseline through Days 3, 8, and 14

• Time to Undetectable RSV Viral Load

  Up to 21 days

• Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study

  Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21

Study Arms (2)

Part 1-Observational Phase

OTHER

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).

Other: RSV Mobile Application

Part 2-Interventional Phase

EXPERIMENTAL

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.

Drug: Placebo; Drug: JNJ-53718678 2.5 mg/kg; Drug: JNJ-53718678 3 mg/kg; Drug: JNJ-53718678 4.5 mg/kg

Interventions

RSV Mobile Application OTHER

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.

Part 1-Observational Phase

Placebo DRUG

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.

Part 2-Interventional Phase

JNJ-53718678 2.5 mg/kg DRUG

JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.

Part 2-Interventional Phase

JNJ-53718678 3 mg/kg DRUG

JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.

Part 2-Interventional Phase

JNJ-53718678 4.5 mg/kg DRUG

JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.

Part 2-Interventional Phase

Eligibility Criteria

• Age: 28 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (10)

Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes

San Miguel de Tucumán, Argentina

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Cevaxin 24 de diciembre

Panama City, 000000, Panama

Location

Cevaxin Avenida Mexico

Panama City, 000000, Panama

Location

Cevaxin La Chorrera

Republica de Panama, 000000, Panama

Location

Hsinchu MacKay Memorial Hospital

Hsinchu, 30071, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Department of Pediatrics, MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Chang Gung Memorial Hospital- Linkou

Taoyuan District, 333, Taiwan

Location

St George's University Hospital NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Interventions

JNJ-53718678

Limitations and Caveats

The required number of participants in the interventional phase was not reached, and hence, limiting the interpretability of the data.

Results Point of Contact

• Title: Senior director medical leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: October 10, 2019
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: February 4, 2025
• Results First Posted: June 8, 2022

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (4); PA (3); BE (1); AR (1); GB (1)