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

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

Official Title
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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

Conditions
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AKI, ARDS, COVID

Intervention / Treatment
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* Device: SCD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SCD<br>Cytopheretic device | Device: SCD<br>* cytopheretic device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at Day 60 | All cause mortality at Day 60 | 60 days post treatment | 
| Dialysis Dependency | Dialysis Dependency at Day 60 | 60 days post treatment | 
| Ventilation at Day 28 | Ventilation free survival at Day 28 | 28 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Dependency | Dialysis Dependency at Day 28 | 28 days post treatment | 
| Mortality at Day 28 | All cause mortality at Day 28 | 28 days post treatment | 
| Urinary output change | Change from baseline in urine output | 10 days of treatment | 
| P02/FiO2 change | Change from baseline in PO2/FiO2 | 10 days of treatment | 
| Safety Assessments | Assessment of SAEs, AE and UADEs | 10 days of treatment | 
| SCD Integrity | Assessment of device performance | 10 days of treatment |