Health Condition 1: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: Rilematovir: Participants will receive oral dose of
rilematovir 250 milligrams mg twice daily
bid for 7 days.
Control Intervention1: Placebo: Participants will receive oral dose of plac
Sponsors
Janssen Research Development LLC
Eligibility
Inclusion 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 preexisted Tested positive for RSV infection using a molecularbased diagnostic assay polymerase chain reaction PCR or other on a bilateral nasal midturbinate swab sample Has at least one of the following high risk conditions that predispose them to RSVrelated disease progression a age greater than or equal 65 years b congestive heart failure CHF c chronic obstructive pulmonary disease COPD dasthma 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
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 participantexamination) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Resolution of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ Symptom Scale)Timepoint: From initiation of study treatment up to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve of Administration of Rilematovir up to 12 hours Post Dosing (AUC[0-12h])Timepoint: Days 1, 3 and 8;Change from Baseline Over Time for the Health-Related Quality of Life (HRQOL) as Assessed by 5 Level EuroQol 5 Dimension EQ-5D-5LTimepoint: Baseline up to Day 35;Change from Baseline Over Time for the RiiQ Impact ScalesTimepoint: Baseline up to Day 35;Change from Baseline over Time in RSV Viral LoadTimepoint: Baseline up to Day 21;Change from Baseline Over Time in Severity of the RSV LRTD Symptoms as Assessed by the Participant Using the RiiQ Symptom Scale ScoreTimepoint: Baseline up to Day 35;Duration of HospitalizationTimepoint: From initiation of study treatment up to Day 35;Duration of Oxygen SupplementationTimepoint: From initiation of study treatment up to Day 35;Duration of Selected Post-baseline Emergent (After Start of Study Intervention) Medical Resource UtilizationTimepoint: From initiation of study treatment up to Day 35;Duration of Treatment-emergent New Use or Increased Dose of Systemic or Inhaled Corticosteroids and BronchodilatorsTimepoint: From initiation of study treatment up to Day 35;Duration of Treatment-emergent Use of AntibioticsTimepoint: From initiation of study treatment up to Day 35;Maximum Plasma Concentration (Cmax) of RilematovirTimepoint: Days 1, 3 and 8;Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV Related Complications andor Needing RSV related Medical AttendanceTimepoint: From initiation of study treatment up to Day 35;Percentage of Participants Requiring Hospitalization for Respiratory or Other ReasonsTimepoint: From initiation of study treatment up to Day 35;Percentage of Participants with Adverse Events AEs as Measure of Safety and TolerabilityTimepoint: From initiation of study treatment up to Day 35;Percentage of Participants with New Antibiotic Use or New or Increased Use inCorticosteroids or Home Oxygen Supplementation Bronchodilator Nebulize | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Pvt Ltd
Outcome results
None listed