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

Completed · Not applicable

Conditions studied: AKI, ARDS, COVID

In brief

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

Key facts

Study ID

NCT04395911

Run by

SeaStar Medical

People needed

22

Starts

2020-09-10

Expected to finish

2021-07-21

Last updated by the study team

2021-08-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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