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

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

  • AKI
  • ARDS
  • COVID

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