Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 115
- 主要终点
- reduction in oxygen and ventilation support
研究概览
简要总结
Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.
详细描述
Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.
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
- •18 years or older
- •must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
- •females of child-bearing potential must have a negative serum pregnancy test
- •subject and/or LAR willing to provide informed consent
- •patient agrees to storage of specimens for future testing
- •Inclusion Criteria Recipient:
- •18 years or older
- •must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
- •subject and/or LAR willing to provide informed consent
- •patient agrees to storage of specimens for future testing
排除标准
- •18 years or older
- •receipt of pooled immunoglobulin in past 30 days
- •contraindication to transfusion or history of prior reactions to transfusion blood products
- •females who are identified as donors must not be pregnant
研究组 & 干预措施
best supportive care
Oxygen therapy
干预措施: oxygen therapy (Other)
convalescent plasma
This arm will receive convalescent plasma
干预措施: high-titer anti-Sars-CoV-2 plasma (Biological)
结局指标
主要结局
reduction in oxygen and ventilation support
时间窗: through study completion, an average of 4 weeks
reduction in oxygen and ventilation support
次要结局
未报告次要终点