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
研究组 & 干预措施
Standard Arm
Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection.
Intervention Arm
Participants randomized to the intervention arm will receive standard care plus an infusion of thawed plasma, starting rate 30 ml/hour for 24 hours, increased to 50 ml/hour if deemed to be hypovolemic (low fluid volume). Only non-convalescent (COVID-antibody-free) plasma will be used.
干预措施: Thawed plasma (Biological)
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
- Intensive care unit-free Days(Track patient progress for 30 days post transfusion)
- Fibrinogen 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.)
- 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.)
- Prothrombin time 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