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

NCT ID: NCT03379675

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2019-12-26

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.

Detailed Description

This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment A: JNJ-53718678 500 mg

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

Group Type: EXPERIMENTAL

JNJ-53718678 500 mg

Intervention Type: DRUG

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

Treatment B: JNJ-53718678 80 mg + Placebo

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.

Group Type: EXPERIMENTAL

JNJ-53718678 80 mg

Intervention Type: 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.

Placebo

Intervention Type: 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 C: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

JNJ-53718678 500 mg

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

Intervention Type: DRUG

JNJ-53718678 80 mg

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Core Healthcare Group

Cerritos, California, United States

eStudySite

Chula Vista, California, United States

SC Clinical Research Inc

Garden Grove, California, United States

Lake Internal Medicine Associates

Eustis, Florida, United States

Florida Research Center Inc.

Miami, Florida, United States

Family Medicine

Nampa, Idaho, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

AllinaHealth - Abbott Northwestern Hospital (13520)

Minneapolis, Minnesota, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Onsite Clinical Solutions

Charlotte, North Carolina, United States

Unity Clinical Research

Lindsay, Oklahoma, United States

Spectrum Medical Research

Gaffney, South Carolina, United States

Fusion Clinical Research of Spartanburg

Spartanburg, South Carolina, United States

Hospital Espanol De Bahia Blanca

Bahía Blanca, , Argentina

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, , Argentina

Hospital Privado - Centro Medico de Cordoba

Barrio Parque Velez Sarfield, , Argentina

Fundación Respirar

CABA, , Argentina

Hospital Italiano de La Plata

Ciudad de La Plata, , Argentina

HIGA Prof. Dr. Ramón Carrillo

Ciudadela, , Argentina

Hospital Rawson

Córdoba, , Argentina

Hospital Italiano de Cordoba

Córdoba, , Argentina

Hospital Cordoba

Córdoba, , Argentina

Sanatorio Juan XXIII

General Roca, , Argentina

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

Rosario, , Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, , Argentina

Paratus Clinical Blacktown Clinic

Blacktown, , Australia

Barwon Health - University Hospital Geelong

Geelong, , Australia

Paratus Clinical Kanwal Clinic

Kanwal, , Australia

Paratus Clinical Kippa Ring Clinic

Kippa-Ring, , Australia

Mater Hospital Brisbane

South Brisbane, , Australia

Westmead Hospital

Sydney, , Australia

CHU Saint-Pierre

Brussels, , Belgium

Jaak Mortelmans

Ham, , Belgium

BVBA Dr. Luc Capiau

Massemen, , Belgium

Testumed

Tessenderlo, , Belgium

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, , Brazil

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

Universidade Federal de Santa Catarina

Florianópolis, , Brazil

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

Natal, , Brazil

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

Passo Fundo, , Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Universidade Federal da Bahia - Hospital Professor Edgard Santos

Salvador, , Brazil

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

São Paulo, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Hospital Heliopolis

São Paulo, , Brazil

MHAT 'Sv. Ivan Rilski' Kozloduy EOOD

Kozloduy, , Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

Pernik, , Bulgaria

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

Rousse, , Bulgaria

MHAT 'Dr. Bratan Shukerov'

Smolyan, , Bulgaria

Diagnostic Consultation Centre 'Alexandrovska' EOOD

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

Troyan Municipality, , Bulgaria

Aggarwal and associates Ltd

Brampton, Ontario, Canada

Milestone Research

London, Ontario, Canada

Dr Anil K Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Clinique Force Medic (GCP Trials)

Montreal, Quebec, Canada

Centre Hospitalier d'Agen

Agen, , France

Cabinet du Dr Remaud

Angers, , France

Maison Medicale Rive Sud

Mûrs-Erigné, , France

CHU Nantes - Hotel Dieu

Nantes, , France

Cabinet du Dr Boye

Nantes, , France

Cabinet du Dr Baranes

Paris, , France

MECS GmbH

Berlin, , Germany

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

Frankfurt, , Germany

Klinische Forschung Hannover-Mitte GmbH

Hanover, , Germany

Hausarztpraxis am Lindenplatz

Lübeck, , Germany

Fukui General Clinic

Fukui-shi, , Japan

Koukan Clinic

Kawasaki, , Japan

Shinkomonji hospital

Kitakyushu, , Japan

Musashikoganei Clinic

Koganeishi, , Japan

Medical Square Kuhonji Clinic

Kumamoto, , Japan

Rinku General Medical Center

Osaka, , Japan

Tokyo Shinagawa Hospital

Shinagawa-ku, , Japan

Saino Clinic

Tokorozawa-shi, , Japan

Toyota Kosei Hospital

Toyota, , Japan

Shin Yukuhashi Hospital

Yukuhashi, , Japan

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

Guadalajara, , Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

RM Pharma Specialists

México, , Mexico

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

Monterrey, , Mexico

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

Kielce, , Poland

Centrum Medyczne All Med

Krakow, , Poland

Diamond Clinic

Krakow, , Poland

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

Lodz, , Poland

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

Ostrów Wielkopolski, , Poland

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Wroclaw, , Poland

Krasnogorsk city hospital #1

Krasnogorsk, , Russia

City Polyclinic #25 of the Nevsky District of SPB

Saint Petersburg, , Russia

LLC 'Medical centr 'Reavita Med Spb'

Saint Petersburg, , Russia

Eco-safety Ltd

Saint Petersburg, , Russia

Research Institute of Influenza

Saint Petersburg, , Russia

Soweto Clinical Trial Centre

Johannesburg, , South Africa

Newtown Clinical Research

Johannesburg, , South Africa

Emmed Research

Pretoria, , South Africa

Welkom Clinical Trial Centre

Welkom, , South Africa

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

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

Gyeonggi-do, , South Korea

Gachon University Gil Hospital

Incheon, , South Korea

Inha University Hospital

Incheon, , South Korea

Kangnam Sacred Heart Hospital

Seoul, , South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Hosp. Gral. Univ. de Alicante

Alicante, , Spain

Hosp. Gral. Univ. de Elche

Elche, , Spain

Hosp. Univ. Virgen de Las Nieves

Granada, , Spain

Hosp. Univ. de La Princesa

Madrid, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Alvaro Cunqueiro

Vigo, , Spain

Skanes universitetssjukhus

Malmo, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Akademiska Sjukhuset

Uppsala, , Sweden

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Kuang Tien General Hospital- Dajia

Taichung, , Taiwan

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Far Eastern Memorial Hospital

Taipei, , Taiwan

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

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

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

Kherson, , Ukraine

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

Kyiv, , Ukraine

Policlinic of State Joint Stock Holding Company 'Artem'

Kyiv, , Ukraine

Private Small Enterprise Medical Center Pulse

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

Vinnytsia, , Ukraine

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; France; Germany; Japan; Mexico; Poland; Russia; South Africa; South Korea; Spain; Sweden; Taiwan; Ukraine

References

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.

Reference Type: DERIVED

PMID: 37422079 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003252-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

53718678RSV2004

Identifier Type: OTHER

Identifier Source: secondary_id

CR108419

Identifier Type: -

Identifier Source: org_study_id