Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.
详细描述
This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.
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
- •Male or Female
- •18 years of age or older
- •Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing
- •Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-
- •Severe disease, defined as 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, and/or
- •lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening disease, defined as one or more of the following:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure
- •Patients or their legally authorized representative must provide informed consent.
排除标准
- •Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- •Patients who have received pooled immunoglobulin in past 30 days
- •Contraindication to transfusions or history of prior reactions to transfusion blood products