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Clinical Trials/CTRI/2021/10/037591
CTRI/2021/10/037591
Not yet recruiting
未知

Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device

Aethlon Medical Inc0 sites0 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

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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