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Virus Therapy
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
N/A
Waitlist Available
Led By Usman Shah, MD
Research Sponsored by Aethlon Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (date of consent) to day 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a device called the Hemopurifier® that filters blood to remove viruses. It targets patients with severe or critical COVID-19 who need different treatments. The device works by cleaning the blood outside the body to help patients recover.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (date of consent) to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (date of consent) to day 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of device related adverse events
Incidence of serious adverse events
Incidence of treatment emergent adverse events
Secondary study objectives
Acute Physiology and Chronic Health Evaluation (APACHE)
C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests
D-dimer
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hemopurifier®Experimental Treatment1 Intervention
The Hemopurifier® will be placed within the extracorporeal circuit, all connections secured, treatment will utilize a blood pump at a flow rate of up to 200mL/min. The patients will be monitored for adverse events, device deficiencies and the development of hemodynamic instability. The treatment session will be for 4-6 hours once daily for 4 consecutive days.
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Who is running the clinical trial?
Aethlon Medical Inc.Lead Sponsor
2 Previous Clinical Trials
10 Total Patients Enrolled
Usman Shah, MDPrincipal InvestigatorHoag Memorial Hospital Presbyterian
Steven LaRosa, MDStudy DirectorAethlon Medical Inc.