Convalescent Plasma for the Treatment of Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
研究概览
简要总结
This protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.
详细描述
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
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
- •Age 18 years and older
- •Laboratory confirmed diagnosis of SARS-CoV-2
- •Admitted to an acute care facility for the treatment of COVID-19 complications
- •Informed consent provided by patient or legally authorized representative
- •Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
- •Severe Disease defined as any of the following
- •Respiratory rate > 30/minute
- •Oxygen saturation <94%
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
- •Lung infiltrates >50% within 24 to 48 hours
- •Life-threatening disease defined as any of the following
- •Respiratory failure
- •Septic shock
- •Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy
排除标准
- •Receipt of pooled immunoglobulin in past 30 days
- •Contraindication to transfusion or history of prior reactions to transfusion blood products
研究组 & 干预措施
Intervention Group
Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
干预措施: Convalescent Plasma (Drug)
结局指标
主要结局
Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2
时间窗: 1 year
Number of patients who are consented and ultimately receive convalescent plasma transfusion.
次要结局
- Changes in prothrombin time (PT) in patients after receiving convalescent plasma(0 and 7 days)
- Survival to discharge(0, 1, 2, 3, 7, 14, 28, 60, and 90 days)
- Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma(0 and 7 days)
- Length of hospital stay(0, 1, 2, 3, 7, 14, 28, 60, and 90 days)
- Length of Intensive Care Unit stay(0, 1, 2, 3, 7, 14, 28, 60, and 90 days)
- Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma(0 and 7 days)
- Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma(0 and 7 days)
- Length of intubation(0, 1, 2, 3, 7, 14, 28, 60, and 90 days)
- Changes in complete blood count in patients after receiving convalescent plasma(0 and 7 days)
- Changes in d-dimer in patients after receiving convalescent plasma(0 and 7 days)
- Changes in fibrinogen in patients after receiving convalescent plasma(0 and 7 days)
- Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19(0, 1, 2, 3, 7, 14 days)