Status:
COMPLETED
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
Lead Sponsor:
SeaStar Medical
Conditions:
AKI
ARDS
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04395911
Start Date
September 10 2020
End Date
July 21 2021
Last Update
August 5 2021
Active Locations (3)
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1
University of Kentucky
Lexington, Kentucky, United States, 40506
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Henry Ford Health System
Detroit, Michigan, United States, 48202