Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The goal of the study is to evaluate the use of the Hemopurifier device in
研究概览
简要总结
This is a Treatment of SARS CoV 2 Virus Disease COVID 19 in Humans with Hemopurifier Device. The study population will be patients with COVID 19 who are severely affected or at high risk for severe disease. Up to 15 patients with COVID-19 infection confirmed by SARS-CoV-2 RT-PCR will be enrolled.The patient must have either a double lumen hemodialysis catheter an arteriovenous fistula or graft for treatment. Patients will receive a four hour treatment with the Hemopurifier extracorporeal therapy once daily for up to four days or until discontinued because of clinical improvement or deterioration or upon decision of the Principal Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Laboratory confirmed diagnosis of COVID-19 infection with any of the following disease characteristics 1A Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS) 1B Severe disease, defined as one of the following dyspnea, respiratory frequency more than or equal to 30/min blood oxygen saturation less than or equal to 93 percentage partial pressure of arterial oxygen to fraction of inspired oxygen ratio of more than 300 and or lung infiltrates more than 50 percentage within 24 to 48 hours 1C Life-threatening disease, defined as one of the following respiratory failure septic shock and or multiple organ dysfunction or failure 2 Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management 3 Informed consent from the patient or legal representative
- •Age more than 18 years.
排除标准
- •1 Stroke known or suspected within the last 3 months 2 Severe congestive heart failure NYHA III and IV classes 3 Acute an international normalized ratio INR of greater than 1 5 and any degree of mental alteration encephalopathy in a patient without preexisting cirrhosis and with an illness of less than 26 weeks duration or chronic Childs Pugh C liver disease 4 Known preexisting non COVID 19 related hypercoagulability or another coagulopathy 5 Inability to maintain a mean arterial pressure of more or 65 mm Hg despite vasopressors and fluid resuscitation 6 Patients with known hypersensitivity to any component of the Hemopurifier 7 Lack of commitment for full medical support 8 Contraindications to extracorporeal blood purification therapy such as i Clinically relevant bleeding disorder ii Contraindication to anti-coagulation iii Pregnancy iv Inability to establish functional vascular access v Participation in another competing investigational drug device or vaccine trial vi Administration of an angiotensin converting enzyme ACE inhibitor in the previous 14 days vii Platelet count less than 50000 cells microliter 9 Recent history of unstable or untreated intradialytic hypotension 10 Subject is currently enrolled in an investigational drug or device trial Patient may be enrolled if they have received an investigational agent previously and it is more than 5 half lives since the last dose 11 Any condition that in the opinion of the investigator would preclude the subject from being a suitable candidate for enrolment such as end stage chronic illness with no reasonable expectation of survival to hospital discharge.
结局指标
主要结局
The goal of the study is to evaluate the use of the Hemopurifier device in
时间窗: After each Hemopurifier treatment on day 1 to day 4 48 hours 96 hours 7 day 15 day and 28 day
the treatment of SARS CoV 2 Virus Disease COVID-19
时间窗: After each Hemopurifier treatment on day 1 to day 4 48 hours 96 hours 7 day 15 day and 28 day
次要结局
- The secondary objective is to evaluate efficacy of the Hemopurifier in(patients with COVID 19 based on in hospital morbidity and mortality)