Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections

SeaStar Medical

Status

Completed

Conditions

AKI

COVID

ARDS

Treatments

Device: SCD

Study type

Interventional

Funder types

Industry

Identifiers

NCT04395911

SCD-005

Details and patient eligibility

About

Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.

Enrollment

22 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.