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

NCT04978337 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR10903153718678RSV20082020-005980-30
• Study Type: interventional
• Target: 5
• Locations: 14 countries
• Sites: 86

Brief Summary

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.

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (7)

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores.

  Baseline

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 3

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 8

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 14

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 21

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 28

• Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35

  RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm \[sputum\]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported.

  Day 35

Secondary Outcomes (10)

• Percentage of Participants With Post-Baseline RSV-related Complications

  Up to Day 35

• Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation

  Up to Day 35

• Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection

  Up to Day 35

• Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance

  Up to Day 35

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Day 35

Study Arms (2)

Treatment A: Rilematovir

EXPERIMENTAL

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

Drug: Rilematovir

Treatment B: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Rilematovir DRUG

Rilematovir 250 mg will be administered orally.

Also known as: JNJ-53718678

Treatment A: Rilematovir

Placebo DRUG

Placebo matching to rilematovir will be administered orally.

Treatment B: Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (86)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Fiel Family and Sports Medicine Clinical Research Advantage

Tempe, Arizona, 85283, United States

Location

IMD Clinical Trials

Bakersfield, California, 93309, United States

Location

Hope clinical Research LLC

Canoga Park, California, 91303, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Bensch Clinical Research, LLC

Stockton, California, 95207, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

Location

Best Quality Research Inc

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research, Inc

Homestead, Florida, 33032, United States

Location

Care Partners Clinical Research

Jacksonville, Florida, 32277, United States

Location

Research Institute Of South Florida, Inc.

Miami, Florida, 33173, United States

Location

Pines Care Research Center Inc

Pembroke Pines, Florida, 33024, United States

Location

Santos Research Center

Tampa, Florida, 33615, United States

Location

Privia Medical Group, LLC

Fayetteville, Georgia, 30214, United States

Location

Southcoast Health

Savannah, Georgia, 31406, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Burke Primary Care

Morganton, North Carolina, 28655, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Pulmonologist, Critical Care, and Sleep Medicine

Wyomissing, Pennsylvania, 19610, United States

Location

Piedmont Clinical Research

Fort Mill, South Carolina, 29707, United States

Location

Texas Health Care, PLLC

Fort Worth, Texas, 76133, United States

Location

Mercury Clinical Research

Houston, Texas, 77027, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

SW Research LLC

Houston, Texas, 77081, United States

Location

SMS Clinical Research LLC

Mesquite, Texas, 75149, United States

Location

Rio Grande Valley Clinical Research Institute

Pharr, Texas, 78577, United States

Location

Javara

San Marcos, Texas, 78666, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

Javara

The Woodlands, Texas, 77384, United States

Location

CCT Research at South Ogden Family Medicine

South Ogden, Utah, 84405, United States

Location

Javara

Forest, Virginia, 24551, United States

Location

Frontier Clinical Research

Morgantown, West Virginia, 26505, United States

Location

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, 1425, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, 1878, Argentina

Location

Centro Medico Respire

San Fernando, 1646, Argentina

Location

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, 4000, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, T4000IHE, Argentina

Location

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

Haskovo, 6300, 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

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

Troyan Municipality, 5600, Bulgaria

Location

Dr. Anil K Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Universitatsklinikum Bonn

Bonn, 53105, Germany

Location

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

Frankfurt, 60596, Germany

Location

Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

Leipzig, 04249, Germany

Location

Praxis Dr. Weimer

Reinfeld, 23858, Germany

Location

Strázsahegy Medicina Bt

Budapest, 1171, Hungary

Location

Omnimodus Elixír Kft.

Csorna, 9300, Hungary

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

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

Roma, 00168, Italy

Location

Nishifukuoka Hospital

Fukuoka, 819-8555, Japan

Location

Nagata Hospital

Fukuoka, 832-0059, Japan

Location

Terada Clinic Respiratory Medicine & General Practice

Himeji-shi, 670-0849, Japan

Location

Kamoike ENT allergy clinic

Kagoshima, 890-0063, Japan

Location

Shinkomonji hospital

Kitakyushu, 800-0057, Japan

Location

Koyama Medical Clinic

Nagano, 390-0872, Japan

Location

Tokyo Shinagawa Hospital

Shinagawa-ku, 140-8522, Japan

Location

Gabinet Lekarski Pediatryczno-Alergologiczny

Bialystok, 15-430, Poland

Location

NZOZ Poradnie Specjalistyczne ATOPIA

Krakow, 31159, Poland

Location

ETG Lodz

Lodz, 90-302, Poland

Location

Centrum Innowacyjnych Terapii Sp. z o.o.

Piaseczno, 05500, Poland

Location

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

Wroclaw, 51-162, Poland

Location

Clinical Trial Systems (Pty) Ltd

Gauteng, 0001, South Africa

Location

Private Practice - Dr. Peter Sebastian

KwaZulu-Natal, 4092, South Africa

Location

Hosp. Gral. Univ. de Alicante

Alicante, 3010, Spain

Location

Hosp. Quiron Barcelona

Barcelona, 08023, Spain

Location

Hosp. Gral. Univ. de Elche

Elche, 03203, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Clinico Univ. De Valencia

Valencia, 46010, Spain

Location

Skanes universitetssjukhus

Malmo, 20502, Sweden

Location

PharmaSite

Malmo, 21152, Sweden

Location

ClinSmart Sweden AB

Solna, 171 64, Sweden

Location

Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

The Hospital for Tropical Diseases

Bangkok, 10400, Thailand

Location

Bamrasnaradura Infectious Disease Institute

Nonthaburi, 11000, Thailand

Location

King Chulalongkorn Memorial Hospital

Pathumwan, 10330, Thailand

Location

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

Kharkiv, 61106, Ukraine

Location

City Clinical Hospital #1

Kyiv, 02091, Ukraine

Location

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

Kyiv, 03049, Ukraine

Location

Medical Center 'Consylium Medical'

Kyiv, 04050, Ukraine

Location

Policlinic of State Joint Stock Holding Company 'Artem'

Kyiv, 04050, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

MeSH Terms

Interventions

JNJ-53718678

Limitations and Caveats

As the study was terminated early, a low number of participants were enrolled, hence some efficacy analyses were not performed per change in the planned analysis. Thereby, data were analyzed for safety and selected efficacy parameters only.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 27, 2021
• Study Start: November 17, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: September 24, 2024
• Results First Posted: April 21, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); PL (5); SE (4); TH (3); UA (6); US (35); DE (4); AR (5); JP (7); CA (1); BU (4); HU (2); IT (2); ZA (2)