se of Hemopurifier Device For The Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037591
- Lead Sponsor
- Aethlon Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method