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

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