A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 25
- 主要终点
- Clearance (CL) of TCZ
研究概览
简要总结
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with COVID-19 confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or CT scan
- •Receiving systemic corticosteroids at baseline
- •Oxygen saturation < 93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation > 92% at screening and baseline
排除标准
- •Gestational age < 37 weeks
- •Known severe allergic reactions to TCZ or other monoclonal antibodies
- •Active tuberculosis infection
- •Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)
- •Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)
- •In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments
- •Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment
- •Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
- •Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
研究组 & 干预措施
All Participants
Participants who are hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation will receive a single dose of TCZ on Day 1, with the option to receive a second dose 8-24 hours later if clinically indicated.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Clearance (CL) of TCZ
时间窗: Through Day 28
Serum concentration of TCZ
时间窗: Through Day 28
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
时间窗: Days 0-28
Serum concentration on Day 28 (C day 28) of TCZ
时间窗: Day 28
Volume of distribution of TCZ
时间窗: Through Day 28
Maximum serum concentration (Cmax) of TCZ
时间窗: Through Day 28
次要结局
- Duration of 90% saturation of sIL-6R(Through Day 28)
- Concentration of C-reactive protein (CRP)(Through Day 60)
- Percentage of participants with severe adverse events(Up to 60 days)
- Concentration of IL-6(Through Day 60)
- Concentration of sIL-6R(Through Day 60)
- Percentage of participants with adverse events(Up to 60 days)