RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 6
- 主要终点
- Survival
研究概览
简要总结
The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by the study participant or their legally appointed representative.
- •Age ≥ 18 years
- •Evidence of acute SARS-CoV-2 infection, confirmed by PCR testing
- •Invasive ventilation
- •Fever ≥ 38.5°C, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°C
- •D-dimers ≥ 2mg/L
- •Dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days
排除标准
- •Age > 85 years
- •Pre-existing treatment limitations
- •Pregnancy
- •Confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
- •ST-segment elevation myocardial infarction (STEMI)
- •Participation in an intervention study elsewhere
结局指标
主要结局
Survival
时间窗: 30 days after randomization
Intention to treat analysis
次要结局
- Ventilator-free days(15, 30, 60, 90 days after randomization)
- Frequency of typical complications associated to therapeutic plasma exchange(through study completion, an average of 1 year)
- Survival(15, 30, 60, 90, 365 days after randomization)
- Length of hospital an ICU stay(through study completion, an average of 1 year)
- Improvement defined as two points on seven point ordinal WHO scale(through study completion, an average of 1 year)
- Reduction of vasopressors after TPE treatments(through study completion, an average of 1 year)
- Incidence of acute kidney injury, renal replacement therapy and renal recovery(15, 30, 60, 90 days after randomization)
- Reduction of inflammation mediators, (auto-)antibodies, and coagulation-associated molecules and their temporal correlation to TPE(through study completion, an average of 1 year)
- D-dimer-dependent assessment of therapeutic efficacy.(through study completion, an average of 1 year)
研究者
Christian Nusshag
MD, Attending, Department of Nephrology
University Hospital Heidelberg