NCT04408040终止2 期
Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
研究概览
简要总结
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Documented COVID-19 infection by nasal pharyngeal sampling
- •COVID-19 disease falling into one of the following groups:
- •Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
- •Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg
- •High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years
- •Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease
排除标准
- •History of IgA deficiency
- •History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
结局指标
主要结局
Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
时间窗: 30 days after initial treatment
Number of patients who survived the covid infection after treatment on study.
次要结局
未报告次要终点
研究者
研究点 (2)
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