Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
研究概览
简要总结
The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:
- the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;
- the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;
- the impact of plasma transfusion on the reduction of viral load and inflammation
- safety and tolerability
- clinical efficacy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab;
- •radiologically confirmed pneumonia;
- •SpO2 > 92o/o and < 96% (room air);
- •ongoing thromboembolic prophylaxis.
排除标准
- •Participation to another COVID-19 trial;
- •severe COVID-19 disease (SpO2 < 93o/o in room air);
- •severe allergic transfusion reactions or anaphylaxis in the patient history;
- •documented lgA deficiency;
- •unstable heart disease with signs of circulatory overload;
- •malignancies or other concomitant diseases with poor short-term prognosis;
- •pregnancy.
结局指标
主要结局
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
时间窗: At plasma donation
Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma
时间窗: Change from baseline at day 21
Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)
时间窗: Change from baseline at day 7
Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs
时间窗: Change from day of diagnosis at day 1
Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7
次要结局
- Number of patients with improvement in the 7-points Ordinal Scale(At day 7)
- Proportion of patients with adverse events, severity of adverse events(At day 21)
研究者
Enos Bernasconi
Prof Dr med
Ente Ospedaliero Cantonale, Bellinzona