The Use of Hyperimmune Plasma for the Treatment of COVID-19 Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 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), which originated in Wuhan, China, has become a major concern all over the world.
Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. 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 and womens , 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
- 是
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) positive
- •signed informed consent unless unfeasible for the critical condition
排除标准
- •proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
- •consent denied
结局指标
主要结局
Death
时间窗: within 30 days
death from any cause
次要结局
- viral load(at days 1, 3 and 7)
- length of intensive care unit stay(within 7 days)
- length of hospitalization(within 30 days)
- immune response(at days 1, 3 and 7)
- time to extubation(within 7 days)
研究者
ANNA FALANGA
Prof
A.O. Ospedale Papa Giovanni XXIII