NCT04375098已完成2 期
Efficacy and Safety of Early Anti-SARS-COV-2 Convalescent Plasma in Patients Admitted for COVID-19 Infection: a Randomized Phase II Trial
适应症
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.
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
- 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)
- Median length of admission(1 year follow up)
- Readmission rate (percentage)(1 year follow up)
- Median length of viral clearance(1 year follow up)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 DiseaseSevere COVID-19 DiseaseNCT04542967Hospital Central Militar150
已完成
2 期
Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory FailureCOVID-19NCT04428021A.O.U. Città della Salute e della Scienza180
Unknown
1 期
COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected PatientsModerate COVID-19 Pneumonia, Severe COVID-19 PneumoniaPneumonia, ViralNCT04474340Ministry of Health, Kuwait300
Unknown
2 期
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized SettingCovid19NCT04840459Sohail Rao1,000
终止
2 期
Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19COVIDSARS-CoV 2NCT04393727Azienda Ospedaliero, Universitaria Pisana1