NCT04408209已完成不适用
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Survival
研究概览
简要总结
This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.
详细描述
Convalescent plasma will be collected by plasmapheresis from patients fully recovered from COVID-19 infection and will be administered in patients with severe COVID-19 infection. The results will be compared with an historical matched control.
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
- •Age >18 years
- •Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
- •Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial
- •Severe COVID-19 infection as determined with one of the following:
- •Respiratory rate 30/min
- •Oxygen Hemoglobin Saturation SAT 93
- •CRP >1.5 (upper normal limit <0.5)
- •Ferritin value >100
- •Ratio of PaO2:FiO2 <300mmHg
- •Pulmonary infiltrates in Chest X-Ray or Chest CT scan >50% during 24-48 hours
- •Life threatening infection as determined by one of the following:
- •Respiratory failure
- •Septic Shock
- •Multiple organ failure
- •Signature of informed consent by the patient or legal representative Patients fulfilling criteria 1, 2, 3, 6 and one of criteria 4 or 5 will be eligible for the study.
排除标准
- •Critical illness due to progressive COVID-19 with expected survival time <48 hours
- •Intubated patients >72 hours
- •Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30%
- •Cardiovascular failure requiring 0.5μg/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication
- •Liver Cirrhosis Child C
- •Liver failure with bilirubin >5X ULN and increase of ALT/AST (at least one >10X ULN)
- •Previous history of allergic reaction to blood or blood products transfusion
- •Known IgA deficiency
- •Breast feeding women
- •Pulmonary edema
结局指标
主要结局
Survival
时间窗: Day 60
The primary endpoint of this trial is the survival on day 60.
次要结局
- Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease(Day 21)
研究者
Professor Meletios-Athanasios Dimopoulos
Professor & Rector of the NKU Athens Plasma Cell Dyscrasias Unit Section of Hematology & Medical Oncology Department of Clinical Therapeutics School of Medicine NKU Athens Alexandra Hospital
National and Kapodistrian University of Athens
研究点 (12)
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