Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of participants completing plasma infusion for COVID-19
研究概览
简要总结
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
详细描述
This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will be collected from all participants at eight timepoints, and clinical data will be collected for 30 days or until discharge/death.
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
盲法说明
Masking will not be used. Participants randomized to standard care will not receive a sham treatment.
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 of age or older
- •COVID-19 positive by PCR or assay within 72 hours or less
- •Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening
排除标准
- •mechanically ventilated
- •prisoners
- •receiving resuscitation with blood products for hemorrhagic shock
- •receiving an investigational therapy for COVID-19
- •diagnosed with severe comorbidities
- •not expected to survive more than 24 hours
结局指标
主要结局
Number of participants completing plasma infusion for COVID-19
时间窗: Track patient progress for 30 days post transfusion.
Identification of patient population who are COVID-19-positive and transfused with plasma
Number of participants intubated
时间窗: Track patient progress for 30 days post transfusion
Participants who are intubated during hospital stay
次要结局
- Prothrombin time blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Factor VIII blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- National Early Warning Score change(Track patient progress for 30 days post transfusion)
- In hospital mortality(Track patient progress for 30 days post transfusion)
- Syndecan-1 blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Intensive care unit-free Days(Track patient progress for 30 days post transfusion)
- Angiopoietin 1&2 blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Soluble Tie2 blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Fibrinogen blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Sequential Organ Failure Assessment (SOFA) score change(Track patient progress for 30 days post transfusion)
- Ventilator-free Days(Track patient progress for 30 days post transfusion)
- Partial thromboplastin time blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Von Willebrand Factor Antigen blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Soluble Thrombomodulin blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- D-dimer blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
- Thromboelastography blood test(0, 12, 24, 48, 72 hours. Day 7, 14 and 30.)
研究者
Rondi Gelbard
Associate Professor, Department of Surgery
University of Alabama at Birmingham