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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 84
- 主要终点
- 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
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.
详细描述
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 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)
排除标准
- •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
研究组 & 干预措施
Treatment A: Rilematovir
Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days.
干预措施: Rilematovir (Drug)
Treatment B: Placebo
Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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 14
时间窗: 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 8
时间窗: 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 21
时间窗: 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 35
时间窗: 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.
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
时间窗: 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.
次要结局
- Percentage of Participants With Post-Baseline RSV-related Complications(Up to Day 35)
- Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance(Up to Day 35)
- Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)(Up to Day 35)
- RSV Viral Load Over Time(Baseline, Days 3, 5, 8, 15, and 21)
- Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection(Up to Day 35)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(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(Up to Day 35)
- Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings(Up to Day 35)
- Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings(Up to Day 35)
- Plasma Concentration of Rilematovir(Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8)