CTRI/2021/09/036588Other3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluatethe Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5Years of Age) and Subsequently in Neonates (28 Days of Age), HospitalizedWith Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus(RSV)
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 737
- 试验地点
- 9
- 主要终点
- Respiratory Syncytial Virus (RSV)Recovery Scale (RRS) - The RRS is an ordinal scale assessing a participant’s clinical status.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of rilematovir compared toplacebo treatment with respect to the clinical outcome on the RSV RecoveryScale (RRS). Respiratory syncytial virus (RSV), a negative-stranded ribonucleic acid (RNA)virus belonging to the Pneumoviridae family, is considered the most importantcause of acute lower respiratory tract infection (LRTI) in infants and youngchildren. In most patients, RSV results in upper respiratory tract infection(URTI) eliciting “common coldâ€-like symptoms, which might last up to 2 weeks,and are usually self-limiting. RSV-related LRTI is a major cause of hospitaladmissions and death in young children worldwide. Rilematovir is aninvestigational, small molecule, RSV fusion inhibitor. This study aims toevaluate the efficacy and safety of rilematovir in hospitalized infants andchildren (greater than or equal to [>=] 28 days to less than or equal to [<=] 5years) and, subsequent to the completion of the substudy, in hospitalizedneonates (born at term, less than [<] 28 days of age) with RSV infection. Thestudy will include a Screening Period, a Treatment Period, and a Follow-upPeriod. The total study duration for each participant will be approximately 36days (Screening included). The efficacy assessments include evaluation underthe RRS and the safety assessments include evaluations of physicalexaminations, vital signs, electrocardiograms, clinical laboratory tests, andadverse 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
- 1.00 Day(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •The participant weighs within greater than or equal to 2.4 kilograms (kg) and less than or equal to 24.6 kg.
- •Each participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an informed consent form (ICF) indicating that (s)he understands the purpose of, and procedures required for, the study; is willing for their child to participate in the study; with regards to the concomitant medication, the lifestyle consideration and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/study site personnel.
- •The participant has an acute respiratory illness with at least 1 of the signs/symptoms within 24 hours prior to start of screening and at screening, as evaluated by the investigator in Upper respiratory tract infection: nasal congestion or rhinorrhea; and Lower respiratory tract infection: increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring, or tachypnea), wheezing, cough, cyanosis, or apnea; and systemic/general: feeding difficulties (defined as less than 75 percent intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive).
- •The time of onset of RSV signs/symptoms to the anticipated time of randomization must be less than or equal to 3 days. Onset of signs/symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of signs/symptoms of RSV infection. The time of sign/symptom onset has to be assessed as accurately as possible.
- •Participants are otherwise healthy or have (a) risk factor(s) for severe RSV disease.
排除标准
- •The participant has had either confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (test positive) during the four weeks prior to randomization, or close contact with a person with COVID-19 (test confirmed or suspected SARS CoV-2 infection) within 14 days prior to randomization.
- •Confirmed QT interval corrected for heart rate according to Fridericia’s formula (QTcF) interval greater than (>) 450 milliseconds (msec) per the machine read parameter result at screening. Presence of an abnormal QTcF interval should be confirmed by repeat electrocardiogram (ECG) recording during screening.
- •Known personal or family history of Long QT Syndrome or sudden cardiac death.
- •Presence of repetitive ventricular premature contractions (>10/minutes [min]), second- or third-degree heart block, or complete or incomplete left bundle branch block, or complete right bundle branch block per the machine read ECG result at screening. Presence of any of the above abnormalities should be confirmed by repeat ECG recording during screening.
结局指标
主要结局
Respiratory Syncytial Virus (RSV)Recovery Scale (RRS) - The RRS is an ordinal scale assessing a participant’s clinical status.
时间窗: Upto day 8
次要结局
- Number of Participants with Post-baseline RSV-Related Complications
- Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on ObsRO(Up to Day 21)
- Percentage of Participants with Clinically(Resolved RSV Disease as Assessed by ClinRO Sign/Symptoms Questionnaire)
- Time From Discharge to Resolution of key RSV Signs/Symptoms based on ObsRO Sign/Symptoms Questionnaire
- Time From First Dosing to end of Oxygen Supplementation
- Number of Participants with Adverse Events(Upto Day 35)
- Number of Participants with Abnormalities in Electrocardiograms (ECG)
- Number of Participants with Abnormalities in Clinical Laboratory Values (Hematology,Clinical chemistry, and routine urinalysis)
- Number of Participants with Abnormalities in Vital Signs n(Temperature, pulse/heart rate, and peripheral capillary oxygen saturation([SpO2]) abnormalities will be assessed.)
- Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire(Up to Day 21)
- PRESORS ObsRO Signs/Symptoms(Questionnaire Scores)
- Time to Hospital Discharge From Start of Dosing(Up to Day 35)
- Time to Readiness for Hospital Discharge(Up to Day 35)
- Percentage of Participants Requiring Intensive Care Unit (ICU) Stay(Up to Day 35)
- Change From Baseline in PRESORS ObsRO Signs/Symptoms Questionnaire Scores Over Time(Baseline Up to Day 21)
- Time to end of Supplemental Oxygen and/or Feeding/hydration
- Number of Participants with Medical Encounters and Treatments
- Time to Improvement in ObsRO General Health Questions (GHQ)(Up to Day 21)
- Duration of Requiring ICU Stay(Up to Day 35)
- Percentage of Participants Requiring Rehospitalization for Respiratory/other(Reasons)
- Time to end of Oxygen Supplementation(Up to Day 35)
- Percentage of Participants Requiring Oxygen Supplementation(Up to Day 35)
- Duration of Oxygen Supplementation(Up to Day 35)
- Time to end of Supplemental(Feeding/hydration)
- Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube
- Duration of Supplemental Feeding/hydration(Up to Day 35)
- Number of Participants with Antibiotic Treatment Episodes
- Number of Participants with Systemic or Inhaled Corticosteroids and(Bronchodilators use)
- RSV Viral Load Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 3,(Day 5, and Day 8)
- RSV Viral Load Over Time(From Baseline to Day 21)
- Change From Baseline in RSV Viral Load Over Time
- Percentage of Participants with Undetectable RSV Viral Load(Up to Day 21)
- Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences(Up to Day 21)
- Plasma Concentration of Rilematovir(Post-dose (Day 1) and pre-dose (Day 2))
- Acceptability and Palatability of the(Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s))
研究者
研究点 (9)
Loading locations...
相似试验
终止
3 期
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)Respiratory Tract InfectionsNCT04583280Janssen Research & Development, LLC28
Unknown
2 期
A Study of Rilematovir in Adult patients with Respiratory Syncytial Virus (RSV) InfectionCTRI/2022/01/039085Janssen Research Development LLC180
终止
2 期
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) InfectionRespiratory Syncytial VirusNCT04978337Janssen Research & Development, LLC5
已完成
3 期
Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)Cytomegalovirus InfectionNCT03930615Merck Sharp & Dohme LLC220
终止
3 期
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient SettingCOVID-19NCT04501952Gilead Sciences584