TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 48
- 主要终点
- Number of patients who meet invasive mechanical ventilation or death
研究概览
简要总结
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.
Patients with pneumonia due to SARS-CoV-2 will be randomized to receive or not convalescent plasma collected by recovered patients with previous diagnosis of COVID19
详细描述
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.
Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized to receive or not convalescent plasma.
Patients in the plasma group will receive 200-300 ml of plasma collected by recovered patients with previous diagnosis of COVID19, plus standard therapy; Patients in the control group will receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.
Patients will be followed until day n30 from randomization.
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
- •Age ≥ 18 years old
- •adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (<= 10 days) according to the following definitions:
- •Suggestive radiological imaging (CT, RX, ultrasound);
- •Respiratory failure not fully explained by heart failure or fluid overload;
- •PaO2/FiO2 200-350 mmHg;
- •Signed informed consent
排除标准
- •need of non invasive or invasive mechanical ventilation at the time of randomization;
- •PaO2/FiO2 <200;
- •patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
- •patients who expressly refuse to adhere the clinical study;
- •use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
- •patients participating to other clinical trial.
结局指标
主要结局
Number of patients who meet invasive mechanical ventilation or death
时间窗: at 30 days
Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 \<150 or death
次要结局
- Mortality rates(30 days)
- Hospitalization time(30 days)
- Adverse events(30 days)
- Time to invasive mechanical ventilation or death(30 days)
- Time to virologic recover(30 days)
研究者
Elena Toschi
Research Coordinator
Istituto Superiore di Sanità