2024-516824-32-00招募中3 期
I4V-MC-KHAB: A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients From 1 Year to Less Than 18 Years Old Hospitalized With COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
研究概览
简要总结
To characterize the pharmacokinetics (PK) of baricitinib* in pediatric patients with COVID-19
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must be hospitalized with coronavirus (COVID-19) infection
- •Participants must need oxygen therapy
排除标准
- •Participants must not be taking biologic therapy or other drugs which suppresses the body’s immune response
- •Participants must not have active tuberculosis (TB)
- •Participants must not have any other serious infection (besides COVID-19)
- •Participants must not need a machine to help them breathe (ventilator) at study entry
- •Participants must not have Cancer
- •Participants must not have a history of a blood clot
- •Participants must not be pregnant or breastfeeding
结局指标
主要结局
Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
PK: Maximum Concentration (Cmax) of Baricitinib
PK: Maximum Concentration (Cmax) of Baricitinib
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (6)
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