CTRI/2021/10/037591尚未招募未知
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •4. 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
- •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
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