Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- RNA in SARS-CoV-2
研究概览
简要总结
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
详细描述
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patients must be 18 years of age or older
- •Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- •Patient agrees to storage of specimens for future testing.
排除标准
- •Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
- •Receipt of pooled immunoglobulin in past 30 days
- •Contraindication to transfusion or history of prior reactions to transfusion blood products
结局指标
主要结局
RNA in SARS-CoV-2
时间窗: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
ICU Admissions
时间窗: 90 days after transfusion
Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
Hospital Mortality
时间窗: 90 days after transfusion
Total number of subject deaths.
Hospital Length of Stay (LOS)
时间窗: 90 days after transfusion
The total number of days subjects were admitted to the hospital.
次要结局
- Type of respiratory support(90 days after transfusion or until hospital discharge (whichever comes first))
- Duration of respiratory support(90 days after transfusion or until hospital discharge (whichever comes first))
研究者
Michael J. Joyner, M.D.
Principal Investigator
Mayo Clinic