At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
研究概览
简要总结
This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •UnitedHealthcare member
- •confirmed COVID-19 positive
- •located in an area where Bamlanivimab (LY3819253) is available for infusion
排除标准
- •current (from first symptom report) hospitalization for COVID-19
- •prior administration of Bamlanivimab or other COVID-19 therapies
- •previous COVID-19 diagnosis
- •prior receipt of a COVID-19 vaccine
- •not authorized for patient use per the EUA
研究组 & 干预措施
Participants with COVID-19
Participants testing positive for COVID-19 may be eligible to receive a one-time dose of bamlanivimab 700 mg, delivered via infusion through the vein, lasting around 60 minutes. This infusion will be done in-home and administered by a registered nurse.
干预措施: bamlanivimab (Drug)
结局指标
主要结局
Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
时间窗: Days 1-28 after at-home infusion of Bamlanivimab
Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise
次要结局
- Safety - Documenting Adverse Events After Infusion(Days 1-28 after at-home infusion of Bamlanivimab)
研究者
Daniel Griffin
Daniel Griffin, MD PhD CTropMed CTH
UnitedHealth Group