Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
Device: SCD
cytopheretic device
Inclusion Criteria:
- Informed consent obtained
- Positive COVID-19 test
- Must be receiving medical care in an intensive care nursing situation
- Non-pregnant females
- Intent to deliver full supportive care through aggressive management utilizing all
available therapies for a minimum of 96 hours.
- Platelet count >30,000/mm3 at Screening
- Clinical diagnosis of AKI requiring CRRT or ARDS
Exclusion Criteria:
- Cardiovascular instability that precludes initiation of continuous renal replacement
therapy (CRRT).
- Irreversible brain damage based on available historical and clinical information.
- Presence of any solid organ transplant at any time.
- Patients with stem cell transplant in the previous 100 days or who have not engrafted.
- Acute or chronic use of circulatory support device other than ECMO such as LVADs,
RVADs, BIVADs.
- Metastatic malignancy which is actively being treated or may be treated with
chemotherapy or radiation during the subsequent three month period after study
treatment.
- Chronic immunosuppression defined as >20 mg prednisone qd alone without other
immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate,
rituximab, mycophenolate, cyclosporine).
- Patient is moribund or chronically debilitated for whom full supportive care is not
indicated.
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in
observational studies (NO TEST DEVICE OR DRUG USED) are allowed to participate.
- Any reason the Investigator deems exclusionary.
University of Kentucky
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States