A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus

NCT03379675 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1084192017-003252-2453718678RSV2004
• Study Type: interventional
• Target: 72
• Locations: 19 countries
• Sites: 124

Brief Summary

The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams \[mg\] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (21)

• Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3

  Area under the RSV VL-time curve (AUC) was determined as log10 copies\*hour per milliliter (Log10 copies\*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.

  Baseline through Day 3

• Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5

  Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

  Baseline through Day 5

• Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8

  Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

  Baseline through Day 8

• Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14

  Area under the RSV VL-time curve (AUC) was determined as Log10 copies\*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

  Baseline through Day 14

• Change From Baseline in RSV Viral Load at Day 3

  Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline to Day 3

• Change From Baseline in RSV Viral Load at Day 5

  Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline to Day 5

• Change From Baseline in RSV Viral Load at Day 8

  Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline to Day 8

• Change From Baseline in RSV Viral Load at Day 14

  Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline to Day 14

• Change From Baseline in RSV Viral Load at Day 21

  Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline to Day 21

• RSV Viral Load at Baseline

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Baseline

• RSV Viral Load at Day 3

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Day 3

• RSV Viral Load at Day 5

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Day 5

• RSV Viral Load at Day 8

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Day 8

• RSV Viral Load at Day 14

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Day 14

• RSV Viral Load at Day 21

  RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

  Day 21

• Time to Undetectable RSV Viral Load

  The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.

  Up to Day 21

• Percentage of Participants With Undetectable RSV Viral Load at Day 3

  Percentage of participants with undetectable RSV viral load at Day 3 were reported.

  Day 3

• Percentage of Participants With Undetectable RSV Viral Load at Day 5

  Percentage of participants with undetectable RSV viral load at Day 5 were reported.

  Day 5

• Percentage of Participants With Undetectable RSV Viral Load at Day 8

  Percentage of participants with undetectable RSV viral load at Day 8 were reported.

  Day 8

• Percentage of Participants With Undetectable RSV Viral Load at Day 14

  Percentage of participants with undetectable RSV viral load at Day 14 were reported.

  Day 14

• Percentage of Participants With Undetectable RSV Viral Load at Day 21

  Percentage of participants with undetectable RSV viral load at Day 21 were reported.

  Day 21

Secondary Outcomes (19)

• Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 28

• Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities

  Up to Day 28

• Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities

  Up to Day 28

• Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities

  Up to Day 28

• Peripheral Capillary Oxygen Saturation (SpO2) Over Time

  Baseline, Days 3, 8, 14, and 21

Study Arms (3)

Treatment A: JNJ-53718678 500 mg

EXPERIMENTAL

Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.

Drug: JNJ-53718678 500 mg

Treatment B: JNJ-53718678 80 mg + Placebo

EXPERIMENTAL

Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Drug: JNJ-53718678 80 mg; Drug: Placebo

Treatment C: Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Drug: Placebo

Interventions

JNJ-53718678 500 mg DRUG

Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Treatment A: JNJ-53718678 500 mg

JNJ-53718678 80 mg DRUG

Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Treatment B: JNJ-53718678 80 mg + Placebo

Placebo DRUG

In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Treatment B: JNJ-53718678 80 mg + Placebo; Treatment C: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
• Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
• Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile
• A male participant must agree to the use of acceptable contraceptive measures
• With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening

You may not qualify if:

• Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
• History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
• Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
• Participants who are considered by the investigator to be immunocompromised within the past 12 months
• Participant has known or suspected chronic or acute hepatitis B or C infection
• Women who are pregnant or breastfeeding
• Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia \[QTcF\] interval greater than \[\>\] 500 millisecond \[ms\]) not consistent with the underlying condition in the study population, as judged by the investigator

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (124)

Core Healthcare Group

Cerritos, California, 90703, United States

Location

eStudySite

Chula Vista, California, 919111, United States

Location

SC Clinical Research Inc

Garden Grove, California, 92844, United States

Location

Lake Internal Medicine Associates

Eustis, Florida, 32726, United States

Location

Florida Research Center Inc.

Miami, Florida, 33174, United States

Location

Family Medicine

Nampa, Idaho, 83686, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

AllinaHealth - Abbott Northwestern Hospital (13520)

Minneapolis, Minnesota, 55407, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Unity Clinical Research

Lindsay, Oklahoma, 73052, United States

Location

Spectrum Medical Research

Gaffney, South Carolina, 29341, United States

Location

Fusion Clinical Research of Spartanburg

Spartanburg, South Carolina, 29301, United States

Location

Hospital Espanol De Bahia Blanca

Bahía Blanca, 8000, Argentina

Location

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, B8001DDU, Argentina

Location

Hospital Privado - Centro Medico de Cordoba

Barrio Parque Velez Sarfield, X5016KEH, Argentina

Location

Fundación Respirar

CABA, C1426ABP, Argentina

Location

Hospital Italiano de La Plata

Ciudad de La Plata, B1900AX, Argentina

Location

HIGA Prof. Dr. Ramón Carrillo

Ciudadela, 1702, Argentina

Location

Hospital Rawson

Córdoba, 5000, Argentina

Location

Hospital Italiano de Cordoba

Córdoba, X5004BAL, Argentina

Location

Hospital Cordoba

Córdoba, X5004CDT, Argentina

Location

Sanatorio Juan XXIII

General Roca, 8332, Argentina

Location

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

Rosario, S2000DEJ, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, T4000IHE, Argentina

Location

Paratus Clinical Blacktown Clinic

Blacktown, 2060, Australia

Location

Barwon Health - University Hospital Geelong

Geelong, 3220, Australia

Location

Paratus Clinical Kanwal Clinic

Kanwal, 2059, Australia

Location

Paratus Clinical Kippa Ring Clinic

Kippa-Ring, 4021, Australia

Location

Mater Hospital Brisbane

South Brisbane, 4101, Australia

Location

Westmead Hospital

Sydney, 2145, Australia

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Jaak Mortelmans

Ham, 3945, Belgium

Location

BVBA Dr. Luc Capiau

Massemen, 9230, Belgium

Location

Testumed

Tessenderlo, 3980, Belgium

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, 18618-970, Brazil

Location

Universidade Federal de Santa Catarina

Florianópolis, 88036-800, Brazil

Location

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, 59025-050, Brazil

Location

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

Passo Fundo, 99010-080, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

Location

Universidade Federal da Bahia - Hospital Professor Edgard Santos

Salvador, 40110-060, Brazil

Location

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

São Paulo, 01308 901, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, 01421-000, Brazil

Location

Hospital Heliopolis

São Paulo, 04231-030, Brazil

Location

MHAT 'Sv. Ivan Rilski' Kozloduy EOOD

Kozloduy, 3320, Bulgaria

Location

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

Pernik, 2000, Bulgaria

Location

SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

Rousse, 7002, Bulgaria

Location

MHAT 'Dr. Bratan Shukerov'

Smolyan, 4703, Bulgaria

Location

Diagnostic Consultation Centre 'Alexandrovska' EOOD

Sofia, 1431, Bulgaria

Location

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

Troyan Municipality, 5600, Bulgaria

Location

Aggarwal and associates Ltd

Brampton, Ontario, L6T 0G1, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Dr Anil K Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Clinique Force Medic (GCP Trials)

Montreal, Quebec, H1M 1B1, Canada

Location

Centre Hospitalier d'Agen

Agen, 47923, France

Location

Cabinet du Dr Remaud

Angers, 49000, France

Location

Maison Medicale Rive Sud

Mûrs-Erigné, 49610, France

Location

CHU Nantes - Hotel Dieu

Nantes, 44093, France

Location

Cabinet du Dr Boye

Nantes, 44300, France

Location

Cabinet du Dr Baranes

Paris, 75020, France

Location

MECS GmbH

Berlin, 12203, Germany

Location

IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

Frankfurt, 60596, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

Hausarztpraxis am Lindenplatz

Lübeck, 23554, Germany

Location

Fukui General Clinic

Fukui-shi, 910-0067, Japan

Location

Koukan Clinic

Kawasaki, 210-0852, Japan

Location

Shinkomonji hospital

Kitakyushu, 800-0057, Japan

Location

Musashikoganei Clinic

Koganeishi, 184-0004, Japan

Location

Medical Square Kuhonji Clinic

Kumamoto, 862-0976, Japan

Location

Rinku General Medical Center

Osaka, 598-8577, Japan

Location

Tokyo Shinagawa Hospital

Shinagawa-ku, 140-8522, Japan

Location

Saino Clinic

Tokorozawa-shi, 359-1141, Japan

Location

Toyota Kosei Hospital

Toyota, 470-0396, Japan

Location

Shin Yukuhashi Hospital

Yukuhashi, 824-0026, Japan

Location

Hospital Cardiologica Aguascalientes

Aguascalientes, 20230, Mexico

Location

Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

Guadalajara, 44130, Mexico

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

RM Pharma Specialists

México, 03100, Mexico

Location

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

Monterrey, 64460, Mexico

Location

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

Kielce, 25-751, Poland

Location

Centrum Medyczne All Med

Krakow, 30 033, Poland

Location

Diamond Clinic

Krakow, 31 559, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni

Lodz, 90-141, Poland

Location

Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna

Ostrów Wielkopolski, 63-400, Poland

Location

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Wroclaw, 51-162, Poland

Location

Krasnogorsk city hospital #1

Krasnogorsk, 143408, Russia

Location

City Polyclinic #25 of the Nevsky District of SPB

Saint Petersburg, 193312, Russia

Location

LLC 'Medical centr 'Reavita Med Spb'

Saint Petersburg, 194354, Russia

Location

Eco-safety Ltd

Saint Petersburg, 196143, Russia

Location

Research Institute of Influenza

Saint Petersburg, 197376, Russia

Location

Soweto Clinical Trial Centre

Johannesburg, 1818, South Africa

Location

Newtown Clinical Research

Johannesburg, 2001, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Welkom Clinical Trial Centre

Welkom, 9460, South Africa

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

The Catholic university of Korea, St. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

Gachon University Gil Hospital

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22322, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 7061, South Korea

Location

Hosp. Gral. Univ. de Alicante

Alicante, 3010, Spain

Location

Hosp. Gral. Univ. de Elche

Elche, 3203, Spain

Location

Hosp. Univ. Virgen de Las Nieves

Granada, 18014, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

Location

Skanes universitetssjukhus

Malmo, 20502, Sweden

Location

Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Kuang Tien General Hospital- Dajia

Taichung, 437, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 11696, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Medical Center of LL Company 'Scientific Medical Center-Your Doctor'

Kharkiv, 61103, Ukraine

Location

Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

Kharkiv, 61106, Ukraine

Location

Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

Kherson, 73000, Ukraine

Location

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, 03049, Ukraine

Location

Policlinic of State Joint Stock Holding Company 'Artem'

Kyiv, 04050, Ukraine

Location

Private Small Enterprise Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

Medical Center Ltd 'Health Clinic', Department Of General Therapy

Vinnytsia, 21009, Ukraine

Location

Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

Vinnytsia, 21021, Ukraine

Location

Related Publications (1)

• Nilsson AC, Pullman J, Napora P, Luz K, Gupta A, Draghi J, Guzman Romero AK, Aggarwal N, Petrova G, Ianus J, Vijgen L, Scott J, Sinha R, Rusch S, Huntjens D, Bertzos K, Stevens M; ROSE Study Group. A pilot phase 2a, randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir at two dose levels in non-hospitalized adults with respiratory syncytial virus infection. Clin Microbiol Infect. 2023 Oct;29(10):1320-1327. doi: 10.1016/j.cmi.2023.07.004. Epub 2023 Jul 6.

  PMID: 37422079 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

JNJ-53718678

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

The Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale that replaced Respiratory Infection-Patient Reported Outcomes (RI-PRO) questionnaire was only evaluated in the 5 participants who were enrolled after implementation of protocol amendment 1. This sample size was too small to draw conclusions on comparison between RiiQ and RI-PRO results.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research and 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: December 15, 2017
• First Posted: December 20, 2017
• Study Start: February 6, 2018
• Primary Completion: November 27, 2019
• Study Completion: December 26, 2019
• Last Updated: February 4, 2025
• Results First Posted: June 28, 2022

Record last verified: 2025-01

Locations

JP (10); ES (6); KR (7); CA (4); AU (6); PL (6); BR (10); BE (4); DE (4); FR (6); RU (5); SE (3); TW (5); UA (8); AR (12); ZA (4); US (13); ME (5); BU (6)