Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- death
研究概览
简要总结
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.
详细描述
Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.
Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.
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 yrs
- •positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
- •Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
- •Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >1.8 mg/dl
- •need for mechanical ventilation or continuous positive airway pressure (CPAP)
- •signed informed consent unless unfeasible for the critical condition
排除标准
- •Moderate to severe ARDS lasting more than 10 days
- •proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
- •consent denied
结局指标
主要结局
death
时间窗: within 7 days
death from any cause
次要结局
- length of intensive care unit stay(within 7 days)
- immune response(at days 1, 3 and 7)
- time to CPAP weaning(within 7 days)
- viral load(at days 1, 3 and 7)
- time to extubation(within 7 days)
研究者
Cesare Perotti
Head, Immunohematology & Transfusion Service
Fondazione IRCCS Policlinico San Matteo di Pavia