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

Primary Purpose

Respiratory Syncytial Virus

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rilematovir
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Alabama Research
  • Fiel Family and Sports Medicine Clinical Research Advantage
  • IMD Clinical Trials
  • Hope clinical Research LLC
  • Peninsula Research Associates
  • Bensch Clinical Research, LLC
  • New Life Medical Research Center, Inc.
  • Best Quality Research Inc
  • Homestead Associates in Research, Inc
  • Care Partners Clinical Research
  • Research Institute Of South Florida, Inc.
  • Pines Care Research Center Inc
  • Santos Research Center
  • Privia Medical Group, LLC
  • Southcoast Health
  • North Georgia Clinical Research
  • Chesapeake Clinical Research, Inc.
  • Montana Medical Research
  • Excel Clinical Research
  • Burke Primary Care
  • Dayton Clinical Research
  • Pulmonologist, Critical Care, and Sleep Medicine
  • Piedmont Clinical Research
  • Texas Health Care, PLLC
  • Mercury Clinical Research
  • Next Level Urgent Care
  • SW Research LLC
  • SMS Clinical Research LLC
  • Rio Grande Valley Clinical Research Institute
  • Javara
  • Renovatio Clinical
  • Javara
  • CCT Research at South Ogden Family Medicine
  • Javara
  • Frontier Clinical Research
  • INAER - Investigación en Alergias y Enfermedades Respiratorias
  • Centro Respiratorio Quilmes
  • Centro Medico Respire
  • Clinica Mayo de UMCB
  • Investigaciones en Patologias Respiratorias
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo
  • Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
  • SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
  • Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
  • Dr. Anil K Gupta Medicine Professional Corporation
  • Universitatsklinikum Bonn
  • IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
  • Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
  • Praxis Dr. Weimer
  • Strázsahegy Medicina Bt
  • Omnimodus Elixír Kft.
  • Fondazione IRCCS Policlinico San Matteo
  • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
  • Nishifukuoka Hospital
  • Nagata Hospital
  • Terada Clinic Respiratory Medicine & General Practice
  • Kamoike ENT allergy clinic
  • Shinkomonji hospital
  • Koyama Medical Clinic
  • Tokyo Shinagawa Hospital
  • Gabinet Lekarski Pediatryczno-Alergologiczny
  • NZOZ Poradnie Specjalistyczne ATOPIA
  • ETG Lodz
  • Centrum Innowacyjnych Terapii Sp. z o.o.
  • Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
  • Clinical Trial Systems (Pty) Ltd
  • Private Practice - Dr. Peter Sebastian
  • Hosp. Gral. Univ. de Alicante
  • Hosp. Quiron Barcelona
  • Hosp. Gral. Univ. de Elche
  • Clinica Univ. de Navarra
  • Hosp. Virgen Macarena
  • Hosp. Clinico Univ. De Valencia
  • PharmaSite
  • Skanes universitetssjukhus
  • ClinSmart Sweden AB
  • Akademiska Sjukhuset
  • The Hospital for Tropical Diseases
  • Bamrasnaradura Infectious Disease Institute
  • King Chulalongkorn Memorial Hospital
  • Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
  • City Clinical Hospital #1
  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • Medical Center 'Consylium Medical'
  • Policlinic of State Joint Stock Holding Company 'Artem'
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment A: Rilematovir

Treatment B: Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 26, 2021
Last Updated
March 30, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04978337
Brief Title
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Acronym
PRIMROSE
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Janssen made the strategic decision to discontinue the PRIMROSE study. This decision is not based on any safety concerns.
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A: Rilematovir
Arm Type
Experimental
Arm Description
Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.
Arm Title
Treatment B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.
Intervention Type
Drug
Intervention Name(s)
Rilematovir
Other Intervention Name(s)
JNJ-53718678
Intervention Description
Rilematovir 250 mg will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to rilematovir will be administered orally.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline
Title
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
Description
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.
Time Frame
Day 3
Title
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
Description
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.
Time Frame
Day 8
Title
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
Description
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.
Time Frame
Day 14
Title
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
Description
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.
Time Frame
Day 21
Title
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
Description
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.
Time Frame
Day 28
Title
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
Description
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.
Time Frame
Day 35
Secondary Outcome Measure Information:
Title
Percentage of Participants With Post-Baseline RSV-related Complications
Description
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.
Time Frame
Up to Day 35
Title
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
Description
New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported.
Time Frame
Up to Day 35
Title
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Description
Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported.
Time Frame
Up to Day 35
Title
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
Description
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.
Time Frame
Up to Day 35
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to Day 35
Title
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
Description
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.
Time Frame
Up to Day 35
Title
Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
Description
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.
Time Frame
Up to Day 35
Title
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Description
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.
Time Frame
Up to Day 35
Title
RSV Viral Load Over Time
Description
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.
Time Frame
Baseline, Days 3, 5, 8, 15, and 21
Title
Plasma Concentration of Rilematovir
Description
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.
Time Frame
Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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