A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 142
- 主要终点
- Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
详细描述
Respiratory syncytial virus (RSV), a negative-stranded ribonucleic acid (RNA) virus belonging to the Pneumoviridae family, is considered the most important cause of acute lower respiratory tract infection (LRTI) in infants and young children. In most patients, RSV results in upper respiratory tract infection (URTI) eliciting "common cold"-like symptoms, which might last up to 2 weeks, and are usually self-limiting. RSV-related LRTI is a major cause of hospital admissions and death in young children worldwide. Rilematovir is an investigational, small molecule, RSV fusion inhibitor. This study aims to evaluate the efficacy and safety of rilematovir in hospitalized infants and children (greater than or equal to [>=] 28 days to less than or equal to [<=] 5 years) and, subsequent to completion of the neonatal substudy, in hospitalized neonates (born at term, less than [<] 28 days of age) with RSV infection. The study will include a Screening Period, a Treatment Period, and a Follow-up Period. The total study duration for each participant will be approximately 36 days (Screening included). The efficacy assessments include evaluation under the RRS 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
- 1 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rilematovir
Participants will receive rilematovir orally based on body weight and age group.
干预措施: Rilematovir (Drug)
Rilematovir
Participants will receive rilematovir orally based on body weight and age group.
干预措施: Rilematovir X mg/kg (Drug)
Placebo
Participants will receive matching placebo of rilematovir based on body weight and age group.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category
时间窗: Baseline to Day 8
RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicates worse condition. With or without signs/symptoms was defined as the key RSV signs/symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) resolved (absent or mild) or not resolved assessed by parent/caregiver.
次要结局
- Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8(Day 8)
- Number of Participants With Abnormalities in Clinical Laboratory Values(Up to Day 35)
- Number of Participants With Abnormalities in Electrocardiograms (ECGs)(Up to Day 35)
- Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir(Up to Day 35)
- Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)(Day 8)
- Number of Participants With Post-baseline RSV-related Complications(Up to Day 35)
- Number of Participants With Abnormalities in Vital Signs(Up to Day 35)
- Duration of Oxygen Supplementation(Up to Day 35)
- Number of Participants With Medical Encounters and Treatments(Up to Day 35)
- Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir(Up to Day 35)
- Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours(Up to Day 21)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 1 up to Day 35)
- Percentage of Participants Requiring Re-hospitalization for Respiratory/Other Reasons(Up to Day 35)
- Percentage of Participants Requiring Oxygen Supplementation After First Dose of Rilematovir(Up to Day 35)
- RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21(Baseline, Days 2, 3, 5, 8, 14 and 21)
- Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21(Baseline, Days 2, 3, 5, 8, 14 and 21)
- Percentage of Participants With Undetectable RSV Viral Load(Baseline, Days 2, 3, 5, 8, 14 and 21)
- Plasma Concentrations of Rilematovir(1 hour Post-dose (Day 1) and pre-dose (Day 2))
- Duration of ICU Stay(Up to Day 35)
- Duration of Supplemental Feeding/Hydration(Up to Day 35)