Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

Study Overview

• Status: Terminated
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: JNJ-53718678; Drug: Placebo

Detailed Description

JNJ-53718678 is an investigational respiratory syncytial virus (RSV) specific fusion inhibitor and is under development for the treatment of RSV infection, which results in an upper and/or lower respiratory tract illness. The primary hypothesis of this study is that JNJ-53718678 has antiviral activity against RSV (that is, results in a decrease in RSV nasal viral load from immediately prior to first dose of study drug until Day 5). This will be assessed by a positive dose-response relationship of JNJ-53718678 compared to placebo. Besides the RSV nasal viral load through day 5, other timepoints will also be evaluated as well as other nasal viral load related parameters. In addition, the evolution of signs and symptoms of RSV disease will be evaluated. Participants' safety will be monitored throughout the study by evaluating the occurrence and severity of adverse events and by laboratory and electrocardiogram measurements. Study participants will be identified when they are hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital (Cohort 1) or present for medical care as outpatients (Cohort 2) with symptoms of an acute respiratory illness supporting a diagnosis of RSV infection. Eligible participants will be randomized 1:1:1 to receive either a low or a high dose of JNJ 53718678 or placebo and will be receiving study treatment for 7 days. They will be followed up for 3 weeks after the last dose. The total study duration for each participant will be approximately 29 days.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Bahía Blanca, Argentina, B8001HXM
    • Hospital Italiano Regional Del Sur
  • Buenos Aires, Argentina, C1426BOS
    • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
  • City of Buenos Aires, Argentina, 1431
    • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • City of Buenos Aires, Argentina, C1270AAN
    • Hospital Pedro de Elizalde
  • Ciudad Autonoma de Buenos Aires, Argentina, C1426ABP
    • Fundacion Respirar
  • Ciudad De La Plata, Argentina, B1900AX
    • Hospital Italiano de La Plata
  • Pilar, Argentina, 1629
    • Hospital Universitario Austral
  • San Miguel de Tucuman, Argentina, T4000IHE
    • Clinica Mayo de UMCB
  • San Miguel de Tucumán, Argentina, 4000
    • Hospital del Nino Jesus
• Belgium
  • Anderlecht, Belgium, 1070
    • ULB Hôpital Erasme
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Liège, Belgium, 4000
    • C.H.R. Citadelle
• Brazil
  • Belo Horizonte, Brazil, 30130-100
    • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Botucatu, Brazil, 18618-686
    • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  • Campinas, Brazil, 13060-904
    • Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
  • Curitiba, Brazil, 80250-060
    • Nucleo de Pesquisa do Hospital Pequeno Princípe
  • Fortaleza, Brazil, 60840-285
    • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Natal, Brazil, 59025-050
    • Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
  • Passo Fundo, Brazil, 99010-080
    • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
  • Porto Alegre, Brazil, 90035-074
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90035-901
    • Associacao Hospitalar Moinhos de Vento
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Sao Paulo, Brazil, 01227-200
    • Fundacao Jose Luiz Egydio Setubal
  • Sorocaba, Brazil, 18040-425
    • CMPC - Consultoria Médica e Pesquisa Clínica
  • Votuporanga, Brazil, 15500-003
    • Santa Casa de Misericórdia de Votuporanga
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4000
    • UMHAT 'Sveti Georgi'-Plovdiv
  • Ruse, Bulgaria, 7002
    • UMHAT 'Kanev' EAD
  • Sevlievo, Bulgaria, 5400
    • Medical Center-1-Sevlievo EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital
  • Sofia, Bulgaria, 1431
    • UMHAT 'Aleksandrovska' EAD
  • Sofia, Bulgaria, 1606
    • SHATCD 'Prof. Ivan Mitev' EAD
  • Sofia, Bulgaria, 1408
    • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
• France
  • CLAMART Cedex, France, 92141
    • Hôpital Antoine Béclère
  • Caen, France, 14033
    • CHU de Caen
  • Montpellier, France, 34070
    • CHU de Montpellier - Arnaud de Villeneuve
  • Nantes, France, 44000
    • CHU de Nantes hotel-Dieu
  • Nice, France, 6200
    • Hopitaux pediatriques CHU Lenval
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades
  • Rouen, France, 76000
    • Hopital Charles Nicolle
• Germany
  • Bramsche, Germany, 49565
    • Kinderarztpraxis Bramsche
  • Hürth, Germany, 50354
    • Hürthpark Kinder & Jugendärzte
  • Schönau am Königssee, Germany, 83471
    • Praxiszentrum Triftplatz
  • Wolfsburg, Germany, 38448
    • Kinderärztliche Gemeinschaftspraxis
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Hungary
  • Budapest, Hungary, 1097
    • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
  • Budapest, Hungary, 1094
    • Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem Klinikai Központ,Infektológiai Klinika
  • Miskolc, Hungary, 3528
    • Futurenest Klinikai Kutató Kft.
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Kórház
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem
  • Székesfehérvár, Hungary, 8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
  • Veszprém, Hungary, 8200
    • Csolnoky Ferenc Korhaz
• Italy
  • Bologna, Italy, 40100
    • A.O.U Sant'Orsola-Malpighi
  • Milan, Italy, 20122
    • Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Milano, Italy, 20154
    • ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
  • Milano, Italy, 20157
    • Dipartimento di Pediatria dell'Ospedale Luigi Sacco
  • Padova, Italy, 35128
    • Azienda Ospedaliera Di Padova
  • Pavia, Italy, 27100
    • Department of Pediatrics University of Pavia, Policlinico San Matteo
  • Ponderano, Italy, 13875
    • Ospedale degli Infermi
• Japan
  • Bunkyo-Ku, Japan, 112-0001
    • Hosaka Kodomo Clinic
  • Fujieda, Japan, 426-0067
    • Kobayashi Pediatric Clinic
  • Fukui City, Japan, 918-8503
    • Fukui-ken Saiseikai Hospital
  • Fukuyama, Japan, 720-8520
    • National Hospital Organization Fukuyama Medical Center
  • Fukuyama, Japan, 721-8511
    • Fukuyama City Hospital
  • Hatsukaichi, Japan, 738-0027
    • Tanabe Pediatrics Clinic
  • Hioki, Japan, 899-2503
    • Kagoshima Children's Hospital
  • Hirosaki, Japan, 036-8545
    • National Hospital Organization Hirosaki General Medical Center
  • Hiroshima, Japan, 734-0023
    • Shirao Clinic of Pediatrics and Pediatric Allergy
  • Kanazawa, Japan, 920-8650
    • National Hospital Organization Kanazawa Medical Center
  • Nagoya, Japan, 457-8511
    • Daido Hospital
  • Nagoya, Japan, 457-8511
    • Kojunkai Daido Clinic
  • Oita, Japan, 874-0011
    • National Hospital Organization Beppu Medical Center
  • Okayama City, Japan, 701-0205
    • Momotaro Clinic
  • Saitama, Japan, 351-0102
    • National Hospital Organization Saitama National Hospital
  • Sapporo, Japan, 062-0931
    • KKR Sapporo Medical Center
  • Setagaya-ku, Japan, 154-0017
    • Tsuda Pediatrics Clinic
  • Tokyo, Japan, 146-0095
    • Okawa Children & Family Clinic
  • Tokyo, Japan, 154-0002
    • INAMI Pediatric clinic
• Korea, Republic of
  • Incheon, Korea, Republic of, 403-720
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center, Eulji University
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 1757
    • Inje University Sanggye Paik Hospital
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • Miri, Malaysia, 98000
    • Hospital Miri
  • Pusat Bandar Kangar, Malaysia, 01000
    • Hospital Tuanku Fauziah
  • Sibu, Malaysia, 96000
    • Hospital Sibu
• Mexico
  • Benito Juarez, Mexico, 03100
    • RM Pharma Specialists
  • Ciudad De Mexico, Mexico, 6720
    • Hospital Infantil de Mexico Federico Gomez
  • Coyoacan, Mexico, 04530
    • Instituto Nacional de Pediatria
  • Guadalajara, Mexico, 44280
    • Hospital Civil de Guadalajara
  • Monterrey, Mexico, 64460
    • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
• Poland
  • Bydgoszcz, Poland, 85-090
    • Osrodek Badan Klinicznych In-Vivo Sp. z o.o.
  • Debica, Poland, 39-200
    • Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej
  • Leczna, Poland, 21-010
    • NZOZ Salmed
  • Rabka-Zdroj, Poland, 34-700
    • Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii
  • Tarnow, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.
  • Trzebnica, Poland, 55-100
    • Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym
• Russian Federation
  • Moscow, Russian Federation, 125367
    • Infectious Clinical Hospital #1 Of The Moscow City Health Department
  • Odintsovo, Russian Federation, 143005
    • OOO MDP-Medical Group
  • Perm, Russian Federation, 614066
    • City Children Clinical Outpatient Clinic #5
  • St. Petersburg, Russian Federation, 193312
    • Children Outpatient Clinic 45 Of Nevskiy Region
  • St. Petersburg, Russian Federation, 196240
    • LLC Kurator
  • St. Petersburg, Russian Federation, 191025
    • OOO 'Medical Technologies'
  • St. Petersburg, Russian Federation, 194223
    • OOO 'Arsvite North-West'
  • St. Petersburg, Russian Federation, 196158
    • LLC Pitercliniсa
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
  • Ufa, Russian Federation, 450083
    • Bashkir State Medical University
  • Yaroslavl, Russian Federation, 150000
    • Yaroslavl State Medical University Based On Children Polyclinics #5
• South Africa
  • Bellville, South Africa, 7505
    • Tygrberg Hospital
  • Bloemfontein, South Africa, 9300
    • JOSHA Research
  • Pretoria, South Africa, 0002
    • Vx Pharma
  • Wynberg, South Africa, 7824
    • Two Military Hospital
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Burgos, Spain, 09006
    • Hosp. Univ. de Burgos
  • Getafe, Spain, 28020
    • Hosp. Univ. de Getafe
  • Madrid, Spain, 28040
    • Hosp. Univ. Fund. Jimenez Diaz
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Majadahonda, Spain, 28221
    • Hosp. Univ. Pta. de Hierro Majadahonda
  • Malaga, Spain, 29011
    • Hosp. Regional Univ. de Malaga
  • Mostoles, Spain, 28938
    • Hosp. Puerta Del Sur
  • Pozuelo de Alarcon, Spain, 28223
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Hosp. Clinico Univ. de Salamanca
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
• Sweden
  • Malmö, Sweden, 20502
    • Barn- och ungdomsmedicin
  • Stockholm, Sweden, 14186
    • Astrid Lindgrens Barnsjukhus Solna
  • Stockholm, Sweden, 11861
    • Sachsska barn-och ungdomssjukhuset
• Taiwan
  • Hsinchu, Taiwan, 30071
    • Hsinchu Mackay Memorial Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11696
    • Taipei Municipal Wanfang Hospital
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital- Linkou
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital Mahidol University
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute of Child Health
  • Bangkok, Thailand, 10400
    • Tropical Medicine Hospital, Mahidol University
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
• Turkey
  • Adana, Turkey, 01330
    • Cukurova University Medical Faculty Balcali Hospital
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Ankara, Turkey, 06100
    • Ankara University Medical Faculty
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty
  • Ankara, Turkey, 06800
    • Ankara Bilkent Sehir Hastanesi
  • Istanbul, Turkey, 34098
    • Istanbul University Istanbul Medical Faculty
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Sarıyer, Turkey, 34453
    • Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik University Medical Faculty
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter Hospital
  • London, United Kingdom, E11 1NR
    • Whipps Cross University Hospital
  • Poole, United Kingdom, BH16 5PW
    • The Adam Practice
• United States
  • California
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Ventura, California, United States, 93003
      • FOMAT Medical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Craig A. Spiegel, MD
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Santiago Reyes, MD
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Health
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Children's Hospital of Richmond at VCU
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent form (ICF) must be given
• Laboratory diagnosis of respiratory syncytial virus (RSV) infection
• The participant has an acute respiratory illness
• The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (<=) 5 days
• 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 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection

Exclusion Criteria:

• The participant is less than (<) 3 months postnatal age at screening and was born prematurely (i.e, <37 weeks and 0 days of gestation) OR if the participant weighs <2.4 kilogram (kg) or greater than (>) 16.8 kg
• Participant is considered by the investigator to be immunocompromised within the past 12 months
• Participant unwilling or unable to undergo mid-turbinate nasal swab procedures
• Participant is receiving chronic home oxygen therapy at screening
• Participant has other clinically significant abnormal electrocardiogram (ECG) findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening
• The participant has a QTcF interval greater than (>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose: JNJ-53718678; Participants will be randomized to receive JNJ-53718678 2.5 milligram per kilogram (mg/kg) (Age Group 1: greater than or equal to [>=] 28 days and less than [<] 3 months of age), 3 mg/kg (Age Group 2: >=3 months and <6 months of age) and 4.5 mg/kg (Age Group 3: >=6 months and less than or equal to [<=3] years of age) orally twice daily for 7 days.	Drug: JNJ-53718678; Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.
Experimental: Low Dose: JNJ-53718678; Participants will be randomized to receive JNJ-53718678 0.85 mg/kg (Age Group 1: >=28 days and <3 months of age), 1 mg/kg (Age Group 2: >=3 months and <6 months of age) and 1.5 mg/kg (Age Group 3: >=6 months and 3 years of age) orally twice daily for 7 days.	Drug: JNJ-53718678; Participants will receive JNJ-53718678 (high dose or low dose) orally twice daily for 7 days.
Placebo Comparator: Placebo; Participants will be randomized to receive matching placebo (i.e. high volume placebo or low volume placebo to match the calculated volume of the JNJ-53718678 for the high dose or low dose) orally twice daily for 7 days.	Drug: Placebo; Participants will receive matching placebo (high volume or low volume) orally twice daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5])	RSV viral load AUC from immediately prior to first dose of study drug through Day 5 was determined. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.	Baseline through Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV Viral Load Over Time	RSV viral load actual values over time were measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.	Baseline, Days 3, 5, 8, 14, and 21
Change From Baseline in RSV Viral Load Over Time	Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.	Baseline up to Days 3, 5, 8, 14, and 21
Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14	LS mean RSV viral load on Days 3, 8, and 14 was reported. LS mean viral load (log10 copies/mL) was estimated per time point. The difference in RSV viral Load AUC (log10 copies*day/mL) from immediately prior to first dose of study drug (baseline) through Day 3, 8 and 14 was determined from the model estimating the LS Mean Viral Load per time point, and is presented in the statistical analysis. The RSV viral load was measured by qRT-PCR assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, and analyzed for this outcome measure at Days 3 and 8, however combined Cohort 1 and Cohort 2 data were not analyzed for this outcome measure at Day 14, due to the premature study termination.	Baseline through Days 3, 8, and 14
Time to Undetectable RSV Viral Load	Time to undetectable RSV viral load (as measured by qRT-PCR) was defined as the time in hours from first dose of study drug to first post-baseline timepoint at which the virus was undetectable and after which there were no more detectable virus assessments. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.	Up to Day 21
Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study	Percentage of participants with undetectable RSV viral load (as measured by qRT-PCR) at each timepoint throughout the study was reported. As planned, combined data for both the cohorts were collected, analyzed and reported for this outcome measure.	Baseline, Days 3, 5, 8, 14 and 21
Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores	PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). PRESORS overall RSV symptoms summary parameter consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.	Baseline up to Days 3, 5, 8, 14 and 21
Change From Baseline in Clinician PRESORS Score	Change from baseline in clinician PRESORS scores (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) was assessed. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease and consisted of 10-items, each item score ranges from 0 to 3. Overall RSV symptoms summary parameter was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.	Baseline, up to Days 3, 5, 8, 14 and 21
Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO)	Time to resolution is defined as time from first dose of study drug until the first time of resolution of all RSV symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.	Up to Day 21
Time to Improvement on Overall Health	Time to improvement based on general questions on overall health was assessed. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.	Up to Day 21
Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time	Percentage of participants by status of RSV symptoms based on PRESORS caregiver (ObsRO) general question over time was assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Status of RSV symptoms was assessed by a question (how would you rate the child's RSV symptoms now?) of PRESORS questionnaire and responses were categorized as: 1) none, 2) very mild, 3) mild, 4) moderate, 5) severe, and 6) very severe.	Baseline, Days 3, 5, 8, 14, and 21
Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time	Percentage of participants by health status assessment based on PRESORS caregiver (ObsRO) general question over time was assessed. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Health status was assessed by a question (how is the child's health now) of PRESORS questionnaire and responses were categorized as: 1) excellent, 2) very good, 3) good, 4) fair, 5) poor, and 6) very poor.	Baseline, Days 3, 5, 8, 14, and 21
Percentage of Participants With Worsening or Improvement Status of RSV Disease	Percentage of participants with worsening or improvement of RSV disease based on general questions of overall health was assessed. Improvement or worsening was assessed by a question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study' and responses were categorized as: 1) very much improved, 2) much improved, 3) a little improved, 4) about the same, 5) a little worse, 6) much worse, and 7) very much worse".	Days 14 and 21
Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time	Percentage of participants by return to pre-RSV disease health status assessment based on PRESORS caregiver (ObsRO) general question over time was assessed by a question (Has the child's health returned to normal [how it was before RSV?]) of PRESORS questionnaire and responses were categorized as: 1) No, and 2) Yes. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues). Below results are reported for category 'Yes'.	Baseline, Days 3, 5, 8, 14, and 21
Respiratory Rate (RR) Over Time	Respiratory rate (RR) was measured by the investigator over time.	Baseline, Days 3, 5, 8, 14 and 21
Change From Baseline in Respiratory Rate	Change from baseline in respiratory rate was derived based on the reported measurements of respiratory rate over time. The respiratory rate over time was reported by the investigator.	Baseline to Days 3, 5, 8, 14 and 21
Heart Rate Over Time	Heart rate was measured by the investigator over time.	Baseline, Days 3, 5, 8, 14 and 21
Change From Baseline in Heart Rate	Change from baseline in heart rate was assessed.	Baseline to Days 3, 5, 8, 14 and 21
Body Temperature Over Time	Body temperature was reported over time (either investigator or caregiver measured).	Baseline, Days 3, 5, 8, 14 and 21
Change From Baseline in Body Temperature	Change from baseline in body temperature (either investigator or caregiver measured) was assessed.	Baseline to Days 3, 5, 8, 14 and 21
Peripheral Capillary Oxygen Saturation (SpO2) Over Time	Peripheral capillary oxygen saturation was measured by the investigator over time.	Baseline, Days 3, 5, 8, 14 and 21
Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2)	Change from baseline in peripheral capillary oxygen saturation levels was derived based on reported values over time.	Baseline to Days 3, 5, 8, 14, and 21
Percentage of Participants Who Required (re)Hospitalization During Treatment and Follow-up	Percentage of participants who required (re)hospitalization during treatment and follow-up was assessed. Percentage of participants requiring re-hospitalization following the initial hospital discharge was assessed in Cohort 1 participants (hospitalized cohort) whilst percentage of participants requiring hospitalization after first dose of study drug was assessed in Cohort 2 participants (outpatient cohort).	Up to Day 28
Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs	Time to return to age-adjusted normal values from first dose of study drug based on the reported vital signs (respiratory rate, heart rate, SpO2 >=92%, and SpO2 >=95%) values was assessed. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 28
Cohort 1: Time to Discharge From Hospital	Time to discharge from hospital was derived from the reported discharge date/time and from first dose date/time. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 28
Cohort 1: Percentage of Participants Who Required Admission to the Intensive Care Unit (ICU)	Percentage of participants who required admission to the ICU was assessed. This outcome measure was applicable for those participants that were not in ICU before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Duration of ICU Stay	Duration of ICU stay was derived based on the reported admission/discharge date/time for ICU. Duration defined as total number of hours a participant was in ICU from first dose of study drug until study termination. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Time to Clinical Stability Evaluated by the Investigator	Time to clinical stability was derived based on vital signs(SpO2 >= 92%, SpO2 >=95% on room air) assessments and supplementation end dates as collected. Time to clinical stability=time from initiation of study treatment until time at which following criteria were met: Time to return to age-adjusted normal value for otherwise healthy, pre-RSV infection status for participant with risk factor for severe RSV disease,no more oxygen supplementation in otherwise healthy participant, participant with risk factor for severe RSV disease and no more IV administered/nasogastric tube feeding/hydration supplementation in otherwise healthy participant or pre-RSV status of IV/nasogastric tube feeding/hydration in participant with risk factor for severe RSV disease. As per protocol and study design,this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Percentage of Participants Who Required Supplemental Oxygen	Percentage of participants who required supplemental oxygen after first dose of study drug was reported. This parameter was only for participants that did not require oxygen supplementation before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Duration of Supplemental Oxygen	Duration of supplemental oxygen was assessed. Duration was defined as total number of hours a participant used supplemental oxygen from first dose of study drug until study termination. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 28
Cohort 1: Percentage of Participants Who Required Non-invasive Mechanical Ventilation Support	Percentage of participants who required non-invasive mechanical ventilation support (example: continuous positive airway pressure) after first dose of study drug was assessed. This parameter was only for participants who did not require non-invasive mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Percentage of Participants Who Required Invasive Mechanical Ventilation Support	Percentage of participants who required invasive mechanical ventilation support (example: endotracheal-mechanical ventilation) after first dose of study drug was assessed. This parameter was only for participants who did not require invasive mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Percentage of Participants Who Required Non-invasive Non-mechanical Ventilation Support	Percentage of participants who required non-invasive non-mechanical ventilation support (example: nasal cannula) after first dose of study drug was assessed. This parameter was only for participants who did not require non-invasive non-mechanical ventilation support before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 21
Cohort 1: Duration of Non-invasive Ventilation Support	For the subset of participants who received non-invasive ventilation post dose, duration for non-invasive ventilation could not be derived by individual type as start/end dates and times were not collected in full to allow breakdown of duration derivation by ventilation type and only overall duration of oxygen supplementation (overall ventilation support) could be derived which is reported in the outcome measure "Duration of Supplemental Oxygen". As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure could only have been reported for Cohort 1.	Up to Day 21
Cohort 1: Duration of Invasive Ventilation Support	For the subset of participants who received invasive ventilation post dose, duration for invasive ventilation could not be derived by individual type as start/end dates and times were not collected in full to allow breakdown of duration derivation by ventilation type and only overall duration of oxygen supplementation (overall ventilation support) could be derived which is reported in the outcome measure "Duration of Supplemental Oxygen". As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure could only have been reported for Cohort 1.	Up to Day 21
Cohort 1: Time to End of Supplemental Oxygen up to 72 Hours From First Hospital Discharge	Time to end of supplemental oxygen up to 72 hours from first hospital discharge was assessed. Time to end of supplemental oxygen was defined as time (hours) from first dose of study drug to last end date/time of any oxygen supplementation received, but within 72 hours following first hospital discharge. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to end of supplemental oxygen including supplemental oxygen within 72 hours after first hospital discharge (up to Day 28)
Cohort 1: Percentage of Participants Who Needed Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube	Percentage of participants who needed hydration and/or feeding by IV Administration or nasogastric tube after the first dose of study drug was assessed. This parameter was only for participants who didn't require supplemental feeding/hydration before first dose of study drug. As per the study protocol and study design, this outcome measure was planned to be analyzed for participants who were hospitalized only. Only participants in Cohort 1 were hospitalized, hence this outcome measure is only reported for Cohort 1.	Up to Day 28
Percentage of Participants With Adverse Events	Percentage of participants with adverse events was assessed. An AE is any untoward medical occurrence in clinical study participants administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention.	Up to Day 28
Percentage of Participants With Abnormal Laboratory Findings	Percentage of participants with abnormal laboratory findings (chemistry and hematology) worst toxicity grade was assessed based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades range from 1 to 4. Grade 1 = mild: transient or mild discomfort (<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.	Up to Day 28
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings	Percentage of participants with abnormal ECG (PR interval [for age 0 to 2 years: >150 msec is abnormally high, for age group 2 to <3.5 years: <100 msec is abnormally low and >150 msec is abnormally high]; QRS interval [for 0 to 2 years: >79 msec is abnormally high, for age group 2 to <3.5 years: <40 msec is abnormally low and >79 msec is abnormally high]; QT interval [for age 0 to 2 years: >500 msec is abnormally high, for age group 2 to <18 years: <320 msec is abnormally low and >450 msec is abnormally high]; RR interval [for age 0 to 3 months: <333 msec is abnormally low and >750 msec is abnormally high; for age group 3 to 12 months: <400 msec is abnormally low and >860 msec is abnormally high; for age 1 to 2 years: <430 msec is abnormally low and >1000 msec is abnormally high; for age group 2 to <18 years: <600 msec is abnormally low and >1200 msec is abnormally high]) findings were assessed.	Up to Day 28
Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF)	Percentage of participants with categorized change from Baseline in ECG parameters (QT/ QTcB/ QTcF interval) was assessed. Abnormal ECG change from baseline in QTc and QTcB Interval is categorized as borderline QTc change: 30 ms (milliseconds) to <60 ms, and abnormally high QTc change: greater than [>] 60 ms), and QTcF Interval is categorized as borderline QTc change: 30 ms to <60 ms, and abnormally high QTc change: >60 ms.	Baseline to Day 28
Percentage of Participants With Vital Signs Abnormalities	Percentage of participants with vital signs (SBP,DBP, pulse rate, respiratory rate, body temperature and SpO2) abnormalities (abnormally low [ABL] and abnormally high [ABH]) were reported. DBP: ABL: <35 mmHg:0-3 months (mths), <40 mmHg:3 mths- <3.5 years,ABH: >65 mmHg:0-3 mths, >85 mmHg:3-12 mths, >90 mmHg:1-2 years, >70 mmHg: 2- <3.5 years; SBP:ABL: <60 mmHg:0-12 mths,<75 mmHg:1-2 years, <80:2- <3.5 years,ABH: >110:0-12 mths, >120 mmHg:1-2 years, >10 mmHg:2- <3.5 years; Pulse rate:ABL: <80 bpm:0-3 mths, <70 bpm:3 mths-12 mth,<60 bpm:1-2 years, <90 bpm:2- <3.5 years,ABH: >180 bpm:0-3 mths, >150 bpm:3 mths-12 mths, >140 bpm:1-2 years, >130:2- <3.5 years; Respiratory rate:ABL: <25 bpm:0-3 mths, <20 bpm: 3 mths-12 mths,<18 bpm:1-2 years, <20 bpm:2- <3.5 years, ABH:>70 bpm:0-3 mths, >60 bpm:3 mths-12 mths, >50 bpm:1-2 years, >35 bpm:2- <3.5 years; SpO2: ABL: <92%: 0-<3.5 years; Temperature (Celsius): ABH:>37.8:Tympanic, >38.0:forehead, oral, axillary, >37.2:rectal.	Up to Day 28
Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours])	AUC (0-24) is defined as area under the plasma concentration-time curve from timepoint 0 hours until 24 hours post dose estimated by population PK model.	0 to 24 hours post dose on Days 1 and 7
Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678	Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.	Days 1 and 7
Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678	Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.	Days 1 and 7
Cohort 2: Plasma Concentration of JNJ-53718678	Plasma concentration of JNJ-53718678 was measured for Cohort-2. As per planned analysis in the protocol, PK sampling was performed on either Day 3 or Day 5 for participants receiving twice daily dosing, resulting in one combined timepoint of Day 3 or Day 5. Hence, the data collected on either Day 3 or Day 5 was pooled and is reported here collectively.	Once daily dosing: Day 3 and Day 8 pre- or post-dose. Twice daily dosing: Day 1 at least 1 hour post-dose, and Days 3 or 5 (combined in one timepoint) at least 4 hours after morning dose but prior to evening dose
Percentage of Participants With Medical Resource Utilization (MRU)	Percentage of participants with MRU (any medical care encounters) was reported.	Up to Day 28
Percentage of Participants With Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)	Percentage of participants with acceptability and palatability of the JNJ-53718678 formulation was assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing that categorized as 1) child took medicine easily, 2) disgusted expressions after tasting medicine, 3) cried after tasting medicine, 4) would not open mouth or turned head away to avoid medicine, 5) spit out or coughed out medicine, 6) gagged, and 7) vomited (within 2 minutes of swallowing medicine). Below results are based on response to "child took medicine easily".	Day 8
Number of Participants With Emerging Variations in the Viral Genome Potentially Associated With Resistance to JNJ-53718678	Number of participants with emerging variations in the viral genome potentially associated with resistance to JNJ-53718678 was reported. Number of participants with F gene sequencing data available and with emerging genetic variations post-baseline as compared to baseline, considering 24 RSV F protein positions of interest (positions 127, 137, 138, 140, 141, 143, 144, 323, 338, 339, 392, 394, 396, 397, 398, 399, 400, 401, 474, 486, 487, 488, 489, and 517) was reported.	Up to Day 21

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): April 18, 2022
• Study Completion (Actual): April 18, 2022

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: CR108520; 2016-003642-93 (EudraCT Number); 53718678RSV2002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No