CTRI/2021/10/037591
Not yet recruiting
未知
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- Aethlon Medical Inc
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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