Convalescent Plasma in the Treatment of COVID 19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
详细描述
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.
1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.
2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All genders
- •Age > 18 yrs and < 90 yrs
- •Must have laboratory confirmed COVID-19
- •Must provide informed consent
- •Must have severe or immediately life-threatening COVID-19,
- •Severe disease is defined as:
- •respiratory frequency ≥ 30/min,
- •blood oxygen saturation ≤ 93%,
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- •lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening disease is defined as:
- •respiratory failure,
- •septic shock
- •multiple organ dysfunction or failure
排除标准
- •No gender exclusion
- •Age < 18 yrs and > 90 yrs
- •COVID-19 negative
结局指标
主要结局
Mortality
时间窗: Up to 28 days
Mortality within 28 days
Viral Load
时间窗: Day 0, Day 3, Day 5, and Day 7
Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).
Serum Antibody Titers
时间窗: Day 0, Day 3, Day 5, and Day 7
Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \> or = 1.0 arbitrary units/mL \[AU/mL\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)
次要结局
未报告次要终点