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

Stopped early · Not applicable

Conditions studied: COVID-19

In brief

This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).

Key facts

Study ID

NCT04595903

Run by

Aethlon Medical Inc.

People needed

1

Starts

2022-06-01

Expected to finish

2022-11-14

Last updated by the study team

2022-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
• i. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS) ii. Severe disease, defined as:
• dyspnea,
• respiratory frequency ≥ 30/min,
• blood oxygen saturation ≤ 93%,,
• partial pressure of arterial oxygen to fraction of inspired oxygen ratio of <300 and/or
• lung infiltrates >50% within 24 to 48 hours; iii. Life-threatening disease, defined as:
• respiratory failure,
• septic shock, and/or
• multiple organ dysfunction or failure.
• Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management
• Subject has maintained a MAP of > or = 65 without an increased dose of vasopressors for at least 2 hours and has clinical evidence of adequate volume status per investigative site criteria
• Informed consent from the patient or legally authorized representative
• Age > 18

You may not qualify if…

• Stroke (known or suspected) within the last 3 months.
• Severe congestive heart failure (NYHA III and IV classes).
• Biopsy proven cancer not in remission.
• 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 26weeks' duration or chronic (Child Pugh C) liver disease.
• Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy
• Terminal illness with a life expectancy of < 28 days or for whom a decision of withdrawal of care is in place or imminently anticipated or patients who have received prior extracorporeal therapy and had persistent, unstable hypotension.
• Patients with known hypersensitivity to any component of the Hemopurifier.
• Advance directive indicating to withhold life-sustaining treatment (except Cardiopulmonary Resuscitation).
• 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 < 50,000 cells/microliter

Where it is running

• Hoag Hospital - Irvine — Irvine, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• UC Davis Health System — Sacramento, California, United States
• University of Miami Hospital — Miami, Florida, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Valley Baptist Medical Center — Harlingen, Texas, United States

Full record on ClinicalTrials.gov

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