Testing the Hemopurifier® Device for Treating COVID-19

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Open to people ages 18 years and up

1. Laboratory diagnosis of COVID-19 infection with any of the following disease characteristics:
2. 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.
• Stable blood pressure not requiring vasopressors.
• Established central access, have received recent hemodialysis and are hemodynamically stable (mean arterial pressure > 70 without vasopressors other than low dose for renal perfusion, HR < 120)
• Informed consent from the patient or legal representative using the associated Patient Informed Consent form must be completed.
• Age > 18

1. Stroke (known or suspected).
2. Severe congestive heart failure (NYHA III and IV classes).
3. Biopsy proven cancer not in remission.
4. Patients with acute or chronic liver failure.
5. Known pre-existing non-COVID-19 related hypercoagulability or other coagulopathy.
6. Concurrent CRRT
7. Terminal illness with a life expectancy of < 28 days or for whom a decision of withdrawal of care is in place or imminently anticipated.
8. Patients with known hypersensitivity to any component of the Hemopurifier.
9. Advance directive indicating no desire for heroic measures.
10. . Voluntary refusal of the patient or the designated legal representative.
11. . Contraindications to extracorporeal blood purification therapy such as:
12. Clinically relevant bleeding disorder, ii. Contraindication to anti-coagulation, iii. Pregnancy, iv. Inability to establish functional vascular access, v. Severe hemodynamic instability, vi. Participation in another competing investigational drug, device or vaccine trial, vii. Administration of an angiotensin converting enzyme (ACE) inhibitor in the previous 14 days.
13. . Recent history of unstable or untreated intradialytic hypotension