Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 106
- 主要终点
- Number of Patients With Disease Progression (Per-protocol Population)
研究概览
简要总结
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
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
- Double (Participant, Outcomes Assessor)
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
- •One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
- •Has at least one study defined risk factor for severe COVID-19 illness
- •Clinical team deems stable for outpatient management without supplemental oxygen
- •CP available at the site at the time of enrollment
- •Duration of symptoms ≤ 7 days at ED presentation
- •Informed consent from subject
排除标准
- •Age less than 18 years
- •Prisoner or ward of the state
- •Presumed unable to complete follow-up assessments
- •Prior adverse reaction(s) from blood product transfusion
- •Receipt of any blood product within the past 120 days
- •Treating clinical team unwilling to administer 300 ml fluid
- •Enrollment in another interventional trial for COVID-19 illness
结局指标
主要结局
Number of Patients With Disease Progression (Per-protocol Population)
时间窗: 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Number of Patients With Disease Progression (Intention-to-treat Population)
时间窗: 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
次要结局
- All-cause Mortality(Assessed at 30 days)
- Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression(15 days)
- Number of Hospital-free Days During the 30 Days Following Randomization(30 days)
- Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization(30 days)