Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- administration of O2
研究概览
简要总结
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.
Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •> 18 years
- •hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
- •informed consent for plasma infusion
- •informed consent to blood samples storing for future studies.
排除标准
- •pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study
- •immunoglobulin infusion in the last month
- •contraindication to transfusion or previous adverse reaction
结局指标
主要结局
administration of O2
时间窗: up to 30 days
O2 support will be monitored and reported in its various modes of administration (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, mechanical ventilation)
hospital mortality
时间窗: up to 90 days
number of subject deaths
ITU admission
时间窗: up to 30 days
number of patients admitted to ITU after immune plasma transfusion
immune plasma infusion adverse reaction
时间窗: in the first 24-48 hours
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
次要结局
未报告次要终点
研究者
mirko lombardi
consultant
Azienda USL Toscana Nord Ovest