A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Safety and tolerability of Remdesivir
研究概览
简要总结
THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.
详细描述
An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6* for final visit.
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
- None
入排标准
- 年龄范围
- 0 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from parents/caregivers
- •Aged 0 to <2 years
- •Weighing at least 2.0 kg
- •Onset of RSV associated-symptoms within 1 week of screening
- •Confirmed* with RSV infection (by rapid antigen test or RT PCR)
- •Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:
- •Inadequate oral feeding
- •Inadequate oxygen saturation (peripheral capillary oxygen saturation [SpO2] <95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)
- •Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use [subcostal, intercostal, or suprasternal retraction], or both)
排除标准
- •Preterm infants (gestational age at birth less than 37 weeks) who are aged <56 days
- •Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)
- •Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV <24 hours prior to study drug dosing (e.g. ribavirin)
- •ALT or AST > 5 × ULN
- •eGFR <30 mL/min/1.73m2 using the Schwartz formula if aged ≥1 year; or if aged <1 year based on a creatinine value cut off dependent on chronological age
- •Any major congenital renal anomaly if <28 days
- •Apgar score < 5 when last recorded if age <24 hours
- •Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- •On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
- •Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives
研究组 & 干预措施
Intervention arm
Remdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation.
干预措施: Remdesivir (Drug)
结局指标
主要结局
Safety and tolerability of Remdesivir
时间窗: 1 Week
Outcome Measures: Occurrence of the following events from the time of randomization until the last study visit: * serious adverse events (SAEs); * adverse events (AEs) of Grade 3 or higher * treatment-related AEs * AEs leading to treatment discontinuation * treatment-related AEs leading to treatment discontinuation * AEs of Grade 3 or higher leading to treatment discontinuation Acceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.
次要结局
- Efficacy of Remdesivir(1 Week)
- Evaluation of the RSV RNA viral load(1 Week)