Severe Acute Respiratory Syndrome Coronavirus 2 of the Genus Betacoronavirus (SARSCoV2) Convalescent Plasma (CP) Expanded Access Protocol (EAP)
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- AdventHealth
- 试验地点
- 1
研究概览
简要总结
Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coronavirus disease (COVID-19 virus). Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus.
详细描述
Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel COVID-19 virus. Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus. The purpose of this trial is to provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 6 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6 and up
- •Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures.
- •Must have laboratory confirmed COVID-19 positive test
- •Must have severe or immediately life-threatening COVID-19
- •Severe disease is defined as:
- •respiratory frequency ≥ 30/min
- •blood oxygen saturation ≤ 93%
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
- •lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening disease is defined as:
- •respiratory failure
- •septic shock, and/or
- •multiple organ dysfunction or failure
排除标准
- •Known contraindication to transfusion or history of prior reactions to transfusion of blood products