This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
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.
Device: Hemopurifier
Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
Inclusion Criteria:
1. 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:
1. respiratory failure,
2. septic shock, and/or
3. 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. 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
4. Informed consent from the patient or legally authorized representative
5. Age > 18
Exclusion Criteria:
1. Stroke (known or suspected) within the last 3 months.
2. Severe congestive heart failure (NYHA III and IV classes).
3. Biopsy proven cancer not in remission.
4. 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.
5. Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy
6. 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.
7. Patients with known hypersensitivity to any component of the Hemopurifier.
8. Advance directive indicating to withhold life-sustaining treatment (except
Cardiopulmonary Resuscitation).
9. 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
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
Steven LaRosa, MD, Study Director
Aethlon Medical Inc.