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A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection

NCT ID: NCT04978337

Last Updated: 2024-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2022-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.

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Detailed Description

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Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 \[depending on timing of first dose\]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

Conditions

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Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A: Rilematovir

Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.

Group Type EXPERIMENTAL

Rilematovir

Intervention Type DRUG

Rilematovir 250 mg will be administered orally.

Treatment B: Placebo

Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching to rilematovir will be administered orally.

Interventions

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Rilematovir

Rilematovir 250 mg will be administered orally.

Intervention Type DRUG

Placebo

Placebo matching to rilematovir will be administered orally.

Intervention Type DRUG

Other Intervention Names

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JNJ-53718678

Eligibility Criteria

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Inclusion Criteria

* Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection
* Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms pre-existed
* Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction \[PCR\] or other) on a bilateral nasal mid-turbinate swab sample
* Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (\>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
* Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms
* Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than \[\<\] 24 hours are not considered as hospitalization)

Exclusion Criteria

* Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation
* Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia
* Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection
* Immunocompromised conditions
* Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Central Alabama Research

Birmingham, Alabama, United States

Site Status

Fiel Family and Sports Medicine Clinical Research Advantage

Tempe, Arizona, United States

Site Status

IMD Clinical Trials

Bakersfield, California, United States

Site Status

Hope clinical Research LLC

Canoga Park, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Bensch Clinical Research, LLC

Stockton, California, United States

Site Status

New Life Medical Research Center, Inc.

Hialeah, Florida, United States

Site Status

Best Quality Research Inc

Hialeah, Florida, United States

Site Status

Homestead Associates in Research, Inc

Homestead, Florida, United States

Site Status

Care Partners Clinical Research

Jacksonville, Florida, United States

Site Status

Research Institute Of South Florida, Inc.

Miami, Florida, United States

Site Status

Pines Care Research Center Inc

Pembroke Pines, Florida, United States

Site Status

Santos Research Center

Tampa, Florida, United States

Site Status

Privia Medical Group, LLC

Fayetteville, Georgia, United States

Site Status

Southcoast Health

Savannah, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Site Status

Montana Medical Research

Missoula, Montana, United States

Site Status

Excel Clinical Research

Las Vegas, Nevada, United States

Site Status

Burke Primary Care

Morganton, North Carolina, United States

Site Status

Dayton Clinical Research

Dayton, Ohio, United States

Site Status

Pulmonologist, Critical Care, and Sleep Medicine

Wyomissing, Pennsylvania, United States

Site Status

Piedmont Clinical Research

Fort Mill, South Carolina, United States

Site Status

Texas Health Care, PLLC

Fort Worth, Texas, United States

Site Status

Mercury Clinical Research

Houston, Texas, United States

Site Status

Next Level Urgent Care

Houston, Texas, United States

Site Status

SW Research LLC

Houston, Texas, United States

Site Status

SMS Clinical Research LLC

Mesquite, Texas, United States

Site Status

Rio Grande Valley Clinical Research Institute

Pharr, Texas, United States

Site Status

Javara

San Marcos, Texas, United States

Site Status

Renovatio Clinical

The Woodlands, Texas, United States

Site Status

Javara

The Woodlands, Texas, United States

Site Status

CCT Research at South Ogden Family Medicine

South Ogden, Utah, United States

Site Status

Javara

Forest, Virginia, United States

Site Status

Frontier Clinical Research

Morgantown, West Virginia, United States

Site Status

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, , Argentina

Site Status

Centro Respiratorio Quilmes

Quilmes, , Argentina

Site Status

Centro Medico Respire

San Fernando, , Argentina

Site Status

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, , Argentina

Site Status

Clinica Mayo de UMCB

San Miguel de Tucumán, , Argentina

Site Status

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo

Haskovo, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

Pernik, , Bulgaria

Site Status

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

Rousse, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

Troyan Municipality, , Bulgaria

Site Status

Dr. Anil K Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Site Status

Universitatsklinikum Bonn

Bonn, , Germany

Site Status

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

Frankfurt, , Germany

Site Status

Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

Leipzig, , Germany

Site Status

Praxis Dr. Weimer

Reinfeld, , Germany

Site Status

Strázsahegy Medicina Bt

Budapest, , Hungary

Site Status

Omnimodus Elixír Kft.

Csorna, , Hungary

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

Roma, , Italy

Site Status

Nishifukuoka Hospital

Fukuoka, , Japan

Site Status

Nagata Hospital

Fukuoka, , Japan

Site Status

Terada Clinic Respiratory Medicine & General Practice

Himeji-shi, , Japan

Site Status

Kamoike ENT allergy clinic

Kagoshima, , Japan

Site Status

Shinkomonji hospital

Kitakyushu, , Japan

Site Status

Koyama Medical Clinic

Nagano, , Japan

Site Status

Tokyo Shinagawa Hospital

Shinagawa-ku, , Japan

Site Status

Gabinet Lekarski Pediatryczno-Alergologiczny

Bialystok, , Poland

Site Status

NZOZ Poradnie Specjalistyczne ATOPIA

Krakow, , Poland

Site Status

ETG Lodz

Lodz, , Poland

Site Status

Centrum Innowacyjnych Terapii Sp. z o.o.

Piaseczno, , Poland

Site Status

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Wroclaw, , Poland

Site Status

Clinical Trial Systems (Pty) Ltd

Gauteng, , South Africa

Site Status

Private Practice - Dr. Peter Sebastian

KwaZulu-Natal, , South Africa

Site Status

Hosp. Gral. Univ. de Alicante

Alicante, , Spain

Site Status

Hosp. Quiron Barcelona

Barcelona, , Spain

Site Status

Hosp. Gral. Univ. de Elche

Elche, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp. Virgen Macarena

Seville, , Spain

Site Status

Hosp. Clinico Univ. De Valencia

Valencia, , Spain

Site Status

Skanes universitetssjukhus

Malmo, , Sweden

Site Status

PharmaSite

Malmo, , Sweden

Site Status

ClinSmart Sweden AB

Solna, , Sweden

Site Status

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

The Hospital for Tropical Diseases

Bangkok, , Thailand

Site Status

Bamrasnaradura Infectious Disease Institute

Nonthaburi, , Thailand

Site Status

King Chulalongkorn Memorial Hospital

Pathumwan, , Thailand

Site Status

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

Kharkiv, , Ukraine

Site Status

City Clinical Hospital #1

Kyiv, , Ukraine

Site Status

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

Kyiv, , Ukraine

Site Status

Medical Center 'Consylium Medical'

Kyiv, , Ukraine

Site Status

Policlinic of State Joint Stock Holding Company 'Artem'

Kyiv, , Ukraine

Site Status

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

Vinnytsia, , Ukraine

Site Status

Countries

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United States Argentina Bulgaria Canada Germany Hungary Italy Japan Poland South Africa Spain Sweden Thailand Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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53718678RSV2008

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005980-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR109031

Identifier Type: -

Identifier Source: org_study_id

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