A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 10
- 主要终点
- Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
研究概览
简要总结
The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.
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
- 28 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part 1: Observational Stage
- •The infant is less than or equal to (<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
- •At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
- •The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •Part 2: Interventional Stage
- •The infant is 28 days and if prematurely born infant (that is [i.e.], less than [<] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
- •The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
- •The participant weighs more than 2.4 kilogram (kg)
- •The participant has an acute respiratory illness as evaluated by the investigator
- •Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
- •The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection
排除标准
- •Part 1: Observational Stage
- •The participant has any physical abnormality which limits the ability to collect regular nasal specimens
- •The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)
- •Part 2: Interventional Stage
- •The participant is <3 months postnatal age at screening and was born prematurely (i.e., <37 weeks and 0 days of gestation) or if the participant weights <2.4 kg
- •The participant has a QT interval with Fridericia's correction (QTcF) greater than (>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
- •The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
- •The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization
研究组 & 干预措施
Part 1-Observational Phase
Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV [-] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV [+] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients).
干预措施: RSV Mobile Application (Other)
Part 2-Interventional Phase
Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.
干预措施: Placebo (Drug)
Part 2-Interventional Phase
Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.
干预措施: JNJ-53718678 2.5 mg/kg (Drug)
Part 2-Interventional Phase
Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.
干预措施: JNJ-53718678 3 mg/kg (Drug)
Part 2-Interventional Phase
Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to [>=] 28 days and less than [<] 3 months): 2.5 milligram per kilogram [mg/kg]; for Age Group 2 (>=3 and <6 months): 3 mg/kg and for Age Group 3 (>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.
干预措施: JNJ-53718678 4.5 mg/kg (Drug)
结局指标
主要结局
Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
时间窗: Baseline (Day 1) up to Day 5
RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
次要结局
- Percentage of Participants With Abnormal Chemistry Laboratory Findings(Up to Day 31)
- Percentage of Participants With Abnormal Urinalysis Laboratory Findings(Up to Day 31)
- Change From Baseline in RSV Viral Load Over Time(Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21)
- RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14(Baseline through Days 3, 8, and 14)
- Time to Undetectable RSV Viral Load(Up to 21 days)
- Percentage of Participants With Worsening or Improvement of RSV Disease(On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- Percentage of Participants With Vital Sign Abnormalities(Up to Day 31)
- Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)(Baseline, Days 3, 5, 8, 14, and 21)
- Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores(Baseline, Day 3, 5, 8, 14, 21)
- Change From Baseline in Clinician PRESORS Score(Baseline, Day 3, 5, 8, 14, 21)
- RSV Viral Load Over Time(Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21)
- Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study(Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21)
- Time to Improvement on Overall Health(Up to 21 days)
- Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)(Up to 21 days)
- Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up(Up to Day 31)
- Time to Resolution of RSV Symptoms(Up to 21 days)
- Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings(Up to Day 31)
- Plasma Concentrations of JNJ-53718678(Day 1 and Day 3)
- Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability(Up to Day 31)