Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 2
研究概览
简要总结
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
详细描述
This expanded access program provides hospitalized patients who are severely or life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma (CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care specialists and Hospitalists identify appropriate patients in accordance with FDA recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP is obtained through New York Blood Center and American Red Cross in coordination with the University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any allergic reactions.Patients admitted to our institution prior to the availability of CCP will be separately reviewed.
研究设计
- 研究类型
- Expanded Access
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
- •Laboratory confirmed COVID-
- •Severe or life-threatening COVID-
- •a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure
排除标准
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- •Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents
- •Other documented uncontrolled infection
- •Severe DIC needing factor replacement, FFP, cryoprecipitate
- •Acute renal failure requiring dialysis
- •Active intracranial bleeding
- •Clinically significant myocardial ischemia
研究者
Marc Klapholz, M.D.
Chair, Department of Medicine; Chief of Medicine Service, University Hospital
Rutgers, The State University of New Jersey