Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-11 @ 7:40 AM
Study NCT ID:
NCT04595903
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2020-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Sponsor:
Aethlon Medical Inc.
Organization:
Study Overview
Official Title:
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of eligible COVID-ICU patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
Detailed Description:
Up to 40 ICU patients with severe or critical illness due to confirmed COVID-19 infection will be enrolled in up to 20 investigational sites. Patients will receive a four to six-hour treatment with the Hemopurifier® extracorporeal therapy daily for up to four days until discontinued because of clinical improvement or deterioration or upon the decision of the Principal Investigator. The patients will be monitored closely with vital signs and for hemodynamic stability. Patients will be followed for adverse events and device deficiencies. Blood work will be obtained.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: