NCT04595903

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Aethlon Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DEVICE	Hemopurifier	Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2020-10-22
• Last updated: 2022-12-20

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study