NCT04343755终止2 期
Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Number of Participants Hospitalized for COVID-19 But Not Intubated
研究概览
简要总结
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
详细描述
Overall study design
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Number of subjects
• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.
Overall study duration
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
- 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
结局指标
主要结局
Number of Participants Hospitalized for COVID-19 But Not Intubated
时间窗: 7 Days
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Primary Objective for Patients With COVID-19 Already Intubated
时间窗: 30 Days
Mortality rate at 30 days from starting treatment for patients with COVID-19
次要结局
- Time to Symptoms Resolution(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30(30 Days)
- Impact of Donor Titers Level on Efficacy(60 Days)
- Duration of Hospitalization(60 Days)
- Duration of Mechanical Ventilation(60 Days)
- Impact of Donor Titers Level on Safety(60 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)(0 Days (pre-infusion))
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 3(3 Days)
- Overall Survival(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 30(30 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 60(60 Days)
研究者
研究点 (2)
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