A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate theEfficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients withRespiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-relatedDisease Progression
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Impact Questionnaire (RiiQ Symptom
研究概览
简要总结
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.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation.
- •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.
结局指标
主要结局
Impact Questionnaire (RiiQ Symptom
时间窗: From initiation of study treatment up to Day | 35
Scale)
时间窗: From initiation of study treatment up to Day | 35
Time to Resolution of Respiratory Syncytial
时间窗: From initiation of study treatment up to Day | 35
Virus (RSV) Lower Respiratory Tract
时间窗: From initiation of study treatment up to Day | 35
Disease (LRTD) Symptoms as Assessed
时间窗: From initiation of study treatment up to Day | 35
by Respiratory Infection Intensity and
时间窗: From initiation of study treatment up to Day | 35
次要结局
- Percentage of Participants with Post Baseline RSV related Complications(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 Nebulizer Systemic)
- Percentage of Participants with(Undetectable RSV Viral Load)
- Percentage of Participants Meeting a(Composite Endpoint of Either Developing)
- Percentage of Participants with Adverse(Events AEs as Measure of Safety and Tolerability)
- Change from Baseline Over Time in(Severity of the RSV LRTD Symptoms as)
- Time to Resolution of LRTD Symptoms and(2 Systemic symptoms as Assessed by RiiQ)
- Time to Resolution of the Overall RSV(Symptoms Upper Respiratory Tract)
- Time to Resolution of all RSV Symptoms as(Assessed by RiiQ Symptom Scale Score)
- Time to Resolution of each Separate RSV(LRTD Symptom as Assessed by RiiQ)
- Time to Resolution of Respiratory Infection(Symptoms as Assessed by Patient Global)
- Time to Return to Pre-existing Health(Status for all RSV Symptoms as Assessed)
- Time to Improvement in RSV Disease as(Assessed by Patient Global Impression of)
- Change from Baseline Over Time for the(RiiQ Impact Scales)
- Time to Return to Usual Health as(Assessed by the Adult RSV Return to)
- Time to Return to Usual Activities as(Assessed by the Adult RSV Return to)
- Time to No or Mild Impact of RSV-related(Disease on Daily Activities, Emotions, and)
- RSV Viral Load Area Under the Curve((AUC) from Immediately Prior to First Dose)
- Change from Baseline over Time in RSV(Viral Load)
- Percentage of Participants with Postbaseline(Sequence Changes in the RSV F)
- Predose Plasma Concentration (Ctrough) of(Rilematovir)
- Maximum Plasma Concentration (Cmax) of(Rilematovir)
- Area Under the Curve of Administration of(Rilematovir up to 12 hours Post Dosing)
- Percentage of Participants with Number(and Type of Medical Encounters)
- Percentage of Participants with Shift in any(Care Setting)
- Percentage of Participants Requiring(Hospitalization for Respiratory or Other)
- Duration of Hospitalization(From initiation of study treatment up to Day)
- Percentage of Participants with Treatmentemergent(New Use or Increased Dose of)
- Duration of Treatment-emergent Use of(Antibiotics)
- Duration of Treatment-emergent New Use(or Increased Dose of Systemic or Inhaled)
- Percentage of Participants with New or(Increased Use of Oxygen Therapy)
- Duration of Oxygen Supplementation(From initiation of study treatment up to Day)
- Duration of Selected Post-baseline(Emergent (After Start of Study Intervention))