Convalescent Plasma for the Treatment of Coronavirus Disease 2019
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Cumulative incidence of serious adverse events related to the treatment intervention.
研究概览
简要总结
This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.
详细描述
Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response.
Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.
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
- •Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)
排除标准
- •History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module [see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf].
- •Has underlying uncompensated and untreatable end stage disease.
- •Fluid overload or other condition that would contraindicate administration of plasma
研究组 & 干预措施
Treatment
All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed.
干预措施: COVID 19 Convalescent Plasma (Biological)
结局指标
主要结局
Cumulative incidence of serious adverse events related to the treatment intervention.
时间窗: up to 60 days post-transfusion
Total number of grade 3 and above throughout study period
Mortality at Day 28 post-hospital admission.
时间窗: up to 28 days post-transfusion
All cause mortality at day 28
次要结局
- Length of hospital stay(up to 60 days post-transfusion)
- Length of mechanical ventilation requirement.(up to 60 days post-transfusion)
- Length of supplemental oxygen requirement.(up to 60 days post-transfusion)
- Length of ICU stay(up to 60 days post-transfusion)
研究者
Brian
Pathologist
The Methodist Hospital Research Institute