A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from pre-dose baseline in WBC count
研究概览
简要总结
This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.
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
- Single (Participant)
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
- •Subject ≥ 18 years, signing the informed consent.
- •SARS-CoV-2 infection by PCR ≤ 7 days
- •One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)
排除标准
- •Recurring COVID-19 patients.
- •Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent
- •Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.
研究组 & 干预措施
BRII-196 and BRII-198 in adult subjects with severe COVID-19
干预措施: BRII-196 and BRII-198 (Drug)
Placebo in adult subjects with severe COVID-19
干预措施: Placebo (Drug)
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19
干预措施: BRII-196 and BRII-198 (Drug)
Placebo in adult subjects with mild-moderate COVID-19
干预措施: Placebo (Drug)
结局指标
主要结局
Change from pre-dose baseline in WBC count
时间窗: Day 29
Change from pre-dose baseline in RBC count
时间窗: Day 29
Incidence of adverse events (AEs)
时间窗: Day 29
Incidence of serious adverse events (SAEs)
时间窗: up to Day 29
Change from pre-dose baseline in Platelets count
时间窗: Day 29
Change from pre-dose baseline in Hemoglobin result
时间窗: Day 29
Change from pre-dose baseline in Creatine kinase result
时间窗: Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
时间窗: Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
时间窗: Day 8
次要结局
- Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19(up to Day 29)
- Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization(up to 72 weeks)
- Assessment of PK parameters: maximum serum concentration observed (Cmax)(up to Day 85)