NCT04747158已完成2 期
COVID-19 Convalescent Plasma Therapy
Universidad Nacional de Asunción2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年8月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Overall survival (30-day mortality)
研究概览
简要总结
This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 [COVID-19] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).
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
- 否
入选标准
- •18 Years and older
- •Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
- •Patients with no more than 15 days from the onset of symptoms
- •Signed informed consent
排除标准
- •Severely ill patients admitted directly to the ICU.
- •Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
- •History of previous hypersensitivity to plasma transfusions.
- •History of immunoglobulin A (IgA) deficiency
- •Pregnancy
结局指标
主要结局
Overall survival (30-day mortality)
时间窗: 30 days
To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.
次要结局
- Change in inflammatory marker: ferritin(0, 7 and 14 days)
- Median length of hospital stay(30 days)
- Change in clinical status(0, 3, 7 and 14 days)
- Change in inflammatory marker: D dimer(0, 7 and 14 days)
- Change in inflammatory marker: leukocytes(0, 7 and 14 days)
- Serum Antibody Titers(0, 3 and 7 days)
- Transfer to ICU(30 days)
- Transfusion related events(4 hours)
研究者
研究点 (2)
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