A Phase-II, Open-Label, Randomized, Multicenter Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of 8 mg/kg or 4mg/kg Intravenous Tocilizumab in Patients With Moderate to Severe COVID-19 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 24
- 主要终点
- Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)
研究概览
简要总结
This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TCZ 4 mg/kg
Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
干预措施: Tociliuzumab (Drug)
TCZ 8 mg/kg
Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
干预措施: Tociliuzumab (Drug)
结局指标
主要结局
Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)
时间窗: Days 0-28. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Maximum Serum Concentration (Cmax) of Tocilizumab
时间窗: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Serum Concentration of Ferritin Following Administration of IV TCZ
时间窗: Baseline - Day 60
Clearance (CL) of Tocilizumab
时间窗: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Volume of the Central Compartment (Vc) of Tocilizumab
时间窗: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ
时间窗: Baseline - Day 60
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ
时间窗: Baseline - Day 60
Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ
时间窗: Baseline - Day 60
次要结局
- Pecentage of Participants With Adverse Events(Up to Day 60)
- Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time(Baseline - Day 60)
- Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity(Up to Day 28)
- Proportion of Participants With Any Post-Treatment Infection(Up to Day 60)