Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization
研究概览
简要总结
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.
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
- •Patient older than 18 years
- •CALL score ≥ 9 (progression risk score)
- •PCR-confirmed COVID-19 infection with equal or less than 7 days of symptoms (or imaging consistent with COVID-19 pneumonia and confirmed COVID-19 contact)
- •Any symptoms of COVID-19 infection
- •Admission due to COVID-19 infection
- •Signed informed consent
- •ECOG before COVID-19 infection 0-2
排除标准
- •PaFi <200 or mechanical ventilation indication
- •Clinically relevant co-infection at admission
- •Pregnancy or lactation
- •IgA deficiency or IgA nephropathy
- •Immunoglobulin or plasma administration in the last 60 days
- •Contraindication to transfusion or previous allergy to blood-derived products
- •Do-not-resuscitate status
- •Patients receiving other investigational drug for COVID-19 in a clinical trial
- •Any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.
研究组 & 干预措施
COVID-19 convalescent plasma
COVID-19 convalescent plasma 200 ml day 1 and 2 only if worsening of respiratory function or persistence of COVID symptoms for >7 days after enrolment
干预措施: COVID-19 convalescent plasma (Biological)
Early COVID-19 convalescent plasma
COVID-19 convalescent plasma 200 ml day 1 and 2 at admission after confirmation of eligibility
干预措施: COVID-19 convalescent plasma (Biological)
结局指标
主要结局
Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization
时间窗: 1 year follow up
次要结局
- Median length of admission(1 year follow up)
- 30-day mortality (percentage)(1 year follow up)
- Hospital mortality rate (percentage)(1 year follow up)
- Median duration of fever(1 year)
- Median duration of mechanical ventilation(1 year follow up)
- Median length of ICU stay(1 year follow up)
- Readmission rate (percentage)(1 year follow up)
- Median length of viral clearance(1 year follow up)