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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
SCD 		Cytopheretic device
  • Device: SCD
    cytopheretic device

Recruiting Locations

More Details

NCT ID
NCT04395911
Status
Completed
Sponsor
SeaStar Medical

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.