Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
详细描述
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age
- •Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
- •Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
- •Severe COVID-19 is defined by one or more of the following:
- •Respiratory frequency ≥ 30/min
- •Blood oxygen saturation ≤ 93%
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- •Lung infiltrates > 50% within 24-48 hours
- •Life-threatening COVID-19 is defined as one or more of the following:
- •Respiratory failure
- •Septic shock
- •Multiple organ dysfunction or failure
排除标准
- •History of prior life-threatening reactions to transfusion of blood products
- •Not receiving other therapies that would preclude plasma transfusion
研究者
Jonathan Gerber
Associate Professor
University of Massachusetts, Worcester