Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
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A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Patients Developing Acute Kidney Injury (AKI) or Acute Respiratory Distress Syndrome (ARDS) Associated With COVID-19 Infection
Actual Study Start Date :
September 10, 2020
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Informed consent obtained
Positive COVID-19 test
Must be receiving medical care in an intensive care nursing situation
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
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Unidentified participant data collected for this study will be submitted to a CRO for data analysis. All data will be submitted to the Sponsor.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Data will be collected throughout the study conduct.
Participant data will be accessible to the Investigational Site and CRO through a secured electronic data capture system. CRO personnel will be responsible for data verification. De-identified Participant information will be accessible to the CRO and the Sponsor.