Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 28 Day Ventilator Free Days
研究概览
简要总结
The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.
Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma.
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
- •There are 2 groups of research subjects: plasma donor and recipients
- •Volunteer plasma donors can donate Convalescent Plasma if they:
- •have adequate antibody levels against COVID-19 per FDA Guidelines
- •have had no symptoms of COVID-19 for at least 14 days
- •meet routine plasma donation criteria
- •Inclusion Criteria for Plasma Recipients:
- •Adults 18 years of age or older
- •Hospitalized with PCR+ COVID-19 infection
- •If female must not be pregnant and/or breastfeeding.
排除标准
- •for Plasma Recipients:
- •Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).
- •In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic
- •Contraindication to transfusion or history of prior reactions to blood transfusions
研究组 & 干预措施
Convalescent Donor Plasma
干预措施: Convalescent Plasma (Biological)
Standard Donor Plasma
干预措施: Standard Donor Plasma (Biological)
结局指标
主要结局
28 Day Ventilator Free Days
时间窗: 28 days post randomization
Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
次要结局
- 90 Day All-cause Mortality(90 days)
研究者
Elliott Bennett-Guerrero
Professor of Anesthesiology
Stony Brook University