Convalescent Plasma in the Treatment of Covid-19
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of days in need of oxygen
研究概览
简要总结
One hundred patients hospitalized and in need of oxygen treatment due to Covid-19 should be randomized and 50% treated with 200 ml convalescent plasma x 3 and 50% given ordinary treatment.
Primary outcome is number of days the patients need oxygen within 28 days from inclusion.
Secondary outcome is number of days in hospital, number of days in respirator and mortality.
Side effects of treatment is monitored.
详细描述
Subjects with previous verified COVID-19 are asked to donate plasma 14 days or later after recovery. IgG antibodies against Covid-19 are measured and only subjects with high titers are accepted. Plasmaphereses is done and up to 600 ml plasma is drawn and aliquoted in 200 ml portions.
Patients with acute respiratory symptoms, verified Covid-19, hospitalized and in need of oxygen treatment are asked to participate in the study. The patients are randomized 50/50 to get either convalescent plasma or routine treatment without plasma. The patients randomized to get plasma will have infusion of 200 ml blood group compatible convalescent plasma daily during three days from different donors.
The clinical course will be carefully monitored and days with oxygen requirement will be compared between the groups. Secondary clinical outcomes as mortality, need of assisted ventilation, total days in hospital and side effects to treatment will be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Verified diagnosis of Covid-19
- •<94% oxygen saturation
- •willingness to participate
- •ability to sign informed consent
排除标准
- •unability to understand information and sign informed consent
- •immunosuppressed patient
结局指标
主要结局
Number of days in need of oxygen
时间窗: 28 days
Number of days in need of oxygen within 28 days from inclusion
次要结局
- Number of days before discharge from hospital(3 months)
- Mortality within 3 months(3 months)
- Number of days before need of assisted ventilation(28 days)
研究者
Mona Landin-Olsson
MD Prof, Senior consultant
Skane University Hospital