A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Disease progression measured by WHO scale
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).
详细描述
This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.
After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients ≥18 years of age
- •Hospitalized with COVID-19-related acute respiratory symptoms
- •Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 ("Hospitalized, no oxygen therapy) or 4 ("Hospitalized, on oxygen by mask or nasal prongs")
- •Laboratory-confirmed COVID-19
- •First signs of infection occurring no more than 14 days prior to enrollment
排除标准
- •Receipt of pooled immunoglobulin in the past 30 days
- •Contraindication to transfusion or history of prior reactions to transfusion blood products
- •Admission to intensive care unit at any point during hospital course prior to enrollment
研究组 & 干预措施
anti-SARS-CoV-2 plasma
Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma
干预措施: anti-SARS-CoV-2 plasma (Drug)
Placebo
Patients receive one dose (250-300ml) of placebo (albumin 5%)
干预措施: Placebo (Other)
结局指标
主要结局
Disease progression measured by WHO scale
时间窗: Day 0 through Day 28 (or hospital discharge)
Disease progression from the state at randomization (with a "3" or "4" on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is "6" or greater on the WHO scale) during the study period
次要结局
- Comparison of decrease of median and maximum WHO score per group(Day 0 through Day 28 (or hospital discharge))
- Comparison of time to reach score of "6" or greater on the WHO scale(Day 0 through Day 28 (or hospital discharge))
- Comparison of maximum WHO score per group(Day 0 through Day 28 (or hospital discharge))
- Comparison of time to clinical improvement per group(Day 0 through Day 28 (or hospital discharge))
研究者
Kashif Khan
Principal Investigator
University of Southern California