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

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Drug: Rilematovir; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, 1425
    • INAER - Investigación en Alergias y Enfermedades Respiratorias
  • Quilmes, Argentina, 1878
    • Centro Respiratorio Quilmes
  • San Fernando, Argentina, 1646
    • Centro Médico Respire
  • San Miguel de Tucuman, Argentina, T4000IHE
    • Clinica Mayo de UMCB
  • San Miguel de Tucumán, Argentina, 4000
    • Investigaciones en Patologias Respiratorias
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo
  • Pernik, Bulgaria, 2000
    • Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
  • Ruse, Bulgaria, 7002
    • SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
  • Troyan, Bulgaria, 5600
    • Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K Gupta Medicine Professional Corporation
• Germany
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn
  • Frankfurt, Germany, 60596
    • IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
  • Leipzig, Germany, 04249
    • Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
  • Reinfeld, Germany, 23858
    • Praxis Dr. Weimer
• Hungary
  • Budapest, Hungary, 1171
    • Strazsahegy Medicina Bt
  • Csorna, Hungary, 9300
    • Omnimodus Elixír Kft.
• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00168
    • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
• Japan
  • Fukuoka, Japan, 819-8555
    • Nishifukuoka Hospital
  • Fukuoka, Japan, 832-0059
    • Nagata Hospital
  • Himeji-shi, Japan, 670-0849
    • Terada Clinic Respiratory Medicine & General Practice
  • Kagoshima, Japan, 890-0063
    • Kamoike ENT Allergy Clinic
  • Kitakyusyu, Japan, 800-0057
    • Shinkomonji hospital
  • Nagano, Japan, 390-0872
    • Koyama Medical Clinic
  • Shinagawa-ku, Japan, 140-8522
    • Tokyo Shinagawa Hospital
• Poland
  • Bialystok, Poland, 15-430
    • Gabinet Lekarski Pediatryczno-Alergologiczny
  • Krakow, Poland, 31159
    • NZOZ Poradnie Specjalistyczne Atopia
  • Lodz, Poland, 90-302
    • ETG Lodz
  • Piaseczno, Poland, 05500
    • Centrum Innowacyjnych Terapii Sp. z o.o.
  • Wroclaw, Poland, 51-162
    • Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
• South Africa
  • Gauteng, South Africa, 0001
    • Clinical Trial Systems (Pty) Ltd
  • KwaZulu-Natal, South Africa, 4092
    • Private Practice - Dr. Peter Sebastian
• Spain
  • Alicante, Spain, 3010
    • Hosp. Gral. Univ. de Alicante
  • Barcelona, Spain, 08023
    • Hosp. Quiron Barcelona
  • Elche, Spain, 03203
    • Hosp. Gral. Univ. de Elche
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Sevilla, Spain, 41009
    • Hosp. Virgen Macarena
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Sweden
  • Malmo, Sweden, 21152
    • PharmaSite
  • Malmö, Sweden, 20502
    • Skånes Universitetssjukhus
  • Solna, Sweden, 171 64
    • ClinSmart Sweden AB
  • Uppsala, Sweden, 75185
    • Akademiska Sjukhuset
• Thailand
  • Bangkok, Thailand, 10400
    • The Hospital for Tropical Diseases
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Disease Institute
  • Pathumwan, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
• Ukraine
  • Kharkiv, Ukraine, 61106
    • Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • Kyiv, Ukraine, 04050
    • Medical Center 'Consylium Medical'
  • Kyiv, Ukraine, 04050
    • Policlinic of State Joint Stock Holding Company 'Artem'
  • Kyiv, Ukraine, 02091
    • City Clinical Hospital #1
  • Vinnytsia, Ukraine, 21029
    • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine Clinical Research Advantage
  • California
    • Bakersfield, California, United States, 93309
      • IMD Clinical Trials
    • Canoga Park, California, United States, 91303
      • Hope clinical Research LLC
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
    • Stockton, California, United States, 95207
      • Bensch Clinical Research, LLC
  • Florida
    • Hialeah, Florida, United States, 33012
      • New Life Medical Research Center, Inc.
    • Hialeah, Florida, United States, 33016
      • Best Quality Research Inc
    • Homestead, Florida, United States, 33032
      • Homestead Associates in Research, Inc
    • Jacksonville, Florida, United States, 32277
      • Care Partners Clinical Research
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida, Inc.
    • Pembroke Pines, Florida, United States, 33024
      • Pines Care Research Center Inc
    • Tampa, Florida, United States, 33615
      • Santos Research Center
  • Georgia
    • Fayetteville, Georgia, United States, 30214
      • Privia Medical Group, LLC
    • Savannah, Georgia, United States, 31406
      • Southcoast Health
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
  • North Carolina
    • Morganton, North Carolina, United States, 28655
      • Burke Primary Care
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Dayton Clinical Research
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Pulmonologist, Critical Care, and Sleep Medicine
  • South Carolina
    • Fort Mill, South Carolina, United States, 29707
      • Piedmont Clinical Research
  • Texas
    • Fort Worth, Texas, United States, 76133
      • Texas Health Care, PLLC
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care
    • Houston, Texas, United States, 77027
      • Mercury Clinical Research
    • Houston, Texas, United States, 77081
      • SW Research LLC
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research LLC
    • Pharr, Texas, United States, 78577
      • Rio Grande Valley Clinical Research Institute
    • San Marcos, Texas, United States, 78666
      • Javara
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
    • The Woodlands, Texas, United States, 77384
      • Javara
  • Utah
    • South Ogden, Utah, United States, 84405
      • CCT Research at South Ogden Family Medicine
  • Virginia
    • Forest, Virginia, United States, 24551
      • Javara
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Frontier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: Rilematovir; Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.	Drug: Rilematovir; Rilematovir 250 mg will be administered orally.; Other Names: JNJ-53718678
Placebo Comparator: Treatment B: Placebo; Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.	Drug: Placebo; Placebo matching to rilematovir will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Post-Baseline RSV-related Complications	RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases [such as COPD and asthma]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure [CHF] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure.	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	New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported.	Up to Day 35
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection	Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported.	Up to Day 35
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance	Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived.	Up to Day 35
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent.	Up to Day 35
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings	Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort [less than {<} 48 hours]; no medical intervention/therapy required); Grade 2:moderate (mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required); Grade 3:severe (severe marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.	Up to Day 35
Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)	Various ECG variables assessed were heart rate: abnormally low (less than or equal to [<=] 45 beats per minute [bpm]), abnormally high (greater than or equal to [>=] 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec); QTc: borderline prolonged: >450 msec and <=480 msec, prolonged: >480 msec and <=500 msec, pathologicaly prolonged: >500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.	Up to Day 35
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings	Abnormal vital parameters included pulse rate: abnormally low <=45 bpm, abnormally high >=120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 millimeter of mercury (mmHg), Grade 1 (mild): >140 mmHg to <160 mmHg, Grade 2 (moderate): >=160 mmHg to <180 mmHg, Grade 3 (severe): >=180 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1: >90 mmHg to <100 mmHg, Grade 2: >=100 mmHg to <110 mmHg, Grade 3: >=110 mmHg; Respiratory rate: Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): >25 breaths per minute, Grade 4 (potentially life threatening): intubation; Oxygen saturation: abnormally low: <95%; Temperature: abnormally high >38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration.	Up to Day 35
RSV Viral Load Over Time	RSV viral load (subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints and RSV subtypes (A or B) for which individual participants had data were reported.	Baseline, Days 3, 5, 8, 15, and 21
Plasma Concentration of Rilematovir	Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported.	Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: CR109031; 53718678RSV2008 (Other Identifier: Janssen Research & Development, LLC); 2020-005980-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No