Clinical trial NCT04978337: A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-07-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Day 3
measure: 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
timeFrame: Day 8
measure: 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
timeFrame: Day 14
measure: 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
timeFrame: Day 21
measure: 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
timeFrame: Day 28
measure: 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
timeFrame: Day 35
Secondary outcomes:
measure: Percentage of Participants With Post-Baseline RSV-related Complications
timeFrame: Up to Day 35
measure: Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
timeFrame: Up to Day 35
measure: Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
timeFrame: Up to Day 35
measure: Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
timeFrame: Up to Day 35
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 35
measure: Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
timeFrame: Up to Day 35
measure: Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
timeFrame: Up to Day 35
measure: Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
timeFrame: Up to Day 35
measure: RSV Viral Load Over Time
timeFrame: Baseline, Days 3, 5, 8, 15, and 21
measure: Plasma Concentration of Rilematovir
timeFrame: Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine Clinical Research Advantage
state: Arizona
city: Bakersfield
country: United States
facility: IMD Clinical Trials
state: California
city: Canoga Park
country: United States
facility: Hope clinical Research LLC
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research, LLC
state: California
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research Inc
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research, Inc
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Institute Of South Florida, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center Inc
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Fayetteville
country: United States
facility: Privia Medical Group, LLC
state: Georgia
city: Savannah
country: United States
facility: Southcoast Health
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Wyomissing
country: United States
facility: Pulmonologist, Critical Care, and Sleep Medicine
state: Pennsylvania
city: Fort Mill
country: United States
facility: Piedmont Clinical Research
state: South Carolina
city: Fort Worth
country: United States
facility: Texas Health Care, PLLC
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: SW Research LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research LLC
state: Texas
city: Pharr
country: United States
facility: Rio Grande Valley Clinical Research Institute
state: Texas
city: San Marcos
country: United States
facility: Javara
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: The Woodlands
country: United States
facility: Javara
state: Texas
city: South Ogden
country: United States
facility: CCT Research at South Ogden Family Medicine
state: Utah
city: Forest
country: United States
facility: Javara
state: Virginia
city: Morgantown
country: United States
facility: Frontier Clinical Research
state: West Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: INAER - Investigación en Alergias y Enfermedades Respiratorias
city: Quilmes
country: Argentina
facility: Centro Respiratorio Quilmes
city: San Fernando
country: Argentina
facility: Centro Medico Respire
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de UMCB
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo
city: Pernik
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
city: Ruse
country: Bulgaria
facility: SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
city: Troyan
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
city: Reinfeld
country: Germany
facility: Praxis Dr. Weimer
city: Budapest
country: Hungary
facility: Strázsahegy Medicina Bt
city: Csorna
country: Hungary
facility: Omnimodus Elixír Kft.
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
city: Fukuoka
country: Japan
facility: Nishifukuoka Hospital
city: Fukuoka
country: Japan
facility: Nagata Hospital
city: Himeji-shi
country: Japan
facility: Terada Clinic Respiratory Medicine & General Practice
city: Kagoshima
country: Japan
facility: Kamoike ENT allergy clinic
city: Kitakyusyu
country: Japan
facility: Shinkomonji hospital
city: Nagano
country: Japan
facility: Koyama Medical Clinic
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital
city: Bialystok
country: Poland
facility: Gabinet Lekarski Pediatryczno-Alergologiczny
city: Krakow
country: Poland
facility: NZOZ Poradnie Specjalistyczne ATOPIA
city: Lodz
country: Poland
facility: ETG Lodz
city: Piaseczno
country: Poland
facility: Centrum Innowacyjnych Terapii Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
city: Gauteng
country: South Africa
facility: Clinical Trial Systems (Pty) Ltd
city: KwaZulu-Natal
country: South Africa
facility: Private Practice - Dr. Peter Sebastian
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Barcelona
country: Spain
facility: Hosp. Quiron Barcelona
city: Elche
country: Spain
facility: Hosp. Gral. Univ. de Elche
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. De Valencia
city: Malmo
country: Sweden
facility: PharmaSite
city: Malmö
country: Sweden
facility: Skanes universitetssjukhus
city: Solna
country: Sweden
facility: ClinSmart Sweden AB
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Bangkok
country: Thailand
facility: The Hospital for Tropical Diseases
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Kharkiv
country: Ukraine
facility: Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
city: Kyiv
country: Ukraine
facility: City Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: Medical Center 'Consylium Medical'
city: Kyiv
country: Ukraine
facility: Policlinic of State Joint Stock Holding Company 'Artem'
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: