Randomized, Controlled, Proof-Of-Concept Trial of CRP-Apheresis for Attenuation of Pulmonary MYocardial and/or Kidney Injury in COvid-19
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 8
- 主要终点
- Necessity and duration of non-invasive/ invasive ventilation
研究概览
简要总结
The 'CAPMYKCO' study is a randomized controlled, open-label, single center proof of concept trial. The aim of this study is to evaluate whether a CRP-apheresis in addition to the current standard therapy is intended to mitigate the severity of the disease course of SARS-CoV-2, especially with regard to tissue injury in the lungs, heart and kidneys and their consequences.
CRP-apheresis should reduce the necessity and duration of non-invasive/invasive ventilation requirements compared to the control group.
The influence of CRP-apheresis on the attenuation of pulmonary, myocardial and/or kidney tissue injury as well as the course of the COVID-19 disease will also be demonstrated by evaluating various biomarkers, several clinical scoring systems, and the duration of intensive care medical treatment.
详细描述
The prognostic value of C-reactive protein (CRP) in assessing disease progression in COVID-19 is well known: The steeper the CRP rise in the days after infection and the higher the CRP concentration at hospitalization, the worse the prognosis. It is believed that CRP concentration not only reflects tissue damage but also causally contributes to the severity of the damage that occurs. CRP apheresis effectively limits CRP rise, which may lead to improved prognosis. CRP apheresis is a therapeutic hemapheresis procedure that selectively removes C-reactive protein from the patient's plasma. Other causal therapies for immediate selective reduction of CRP in the acute phase of disease are not currently available.
In the planned 'CAPMYKCO' study, CRP-apheresis in addition to current standard COVID-19 therapy is expected to mitigate the severity of disease progression, particularly with regard to tissue injury in the lungs, the heart and/or the kidneys and their respective clinical consequences.
CRP-apheresis treatment in COVID-19 patients should reduce the necessity and duration of non-invasive / invasive ventilation compared to the control group.
The influence of CRP-apheresis on the course of the COVID-19 disease will also be demonstrated by evaluating different organ biomarkers and the duration of intensive medical treatment.
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
- •Confirmed SARS CoV-2 infection (PCR-test)
- •Oxygen therapy (maximum 'high-flow' therapy)
- •CRP plasma concentration ≥ 50 mg/l and/or
- •CRP increase ≥ 15 mg/l within 24 h after admission.
- •Completed informed consent and written informed consent.
- •Legal capacity
排除标准
- •Age < 18 years
- •Pregnancy / lactation period
- •Invasive, mechanical ventilation
- •Extracorporeal membrane oxygenation (ECMO)
- •Participation in other interventional trials
- •Extracorporeal membrane oxygenation (ECMO) support
- •Participation in other interventional trials
结局指标
主要结局
Necessity and duration of non-invasive/ invasive ventilation
时间窗: through study completion, an average of 14 days
In the intervention group, a reduced necessity and duration of non-invasive/ invasive ventilation is expected.
次要结局
- Length of intensive care unit stay(through study completion, an average of 14 days)
- Necessity of endotracheal intubation(through study completion, an average of 14 days)
- Reduction of lung injury(through study completion, an average of 14 days)
- Reduction of myocardial damage(up to 10 days)
- Reduction of kidney damage(up to 10 days)
- Improvement in general immune status(up to 10 days)
- Cardiovascular, respiratory and renal SOFA score(through study completion, an average of 14 days)
- Respiratory events(through study completion, an average of 14 days)
- Myocardial events(through study completion, an average of 14 days)
- Renal events(through study completion, an average of 14 days)
- Safety of CRF apheresis(through study completion, an average of 14 days)