AKI, ARDS, COVID
Conditions
Brief summary
Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
Interventions
DEVICESCD
cytopheretic device
Sponsors
SeaStar Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at Day 60 | 60 days post treatment | All cause mortality at Day 60 |
| Dialysis Dependency | 60 days post treatment | Dialysis Dependency at Day 60 |
| Ventilation at Day 28 | 28 days post treatment | Ventilation free survival at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| P02/FiO2 change | 10 days of treatment | Change from baseline in PO2/FiO2 |
| Dialysis Dependency | 28 days post treatment | Dialysis Dependency at Day 28 |
| SCD Integrity | 10 days of treatment | Assessment of device performance |
| Safety Assessments | 10 days of treatment | Assessment of SAEs, AE and UADEs |
| Mortality at Day 28 | 28 days post treatment | All cause mortality at Day 28 |
| Urinary output change | 10 days of treatment | Change from baseline in urine output |
Countries
United States
Outcome results
None listed