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

Not Applicable

Completed

• Conditions: ARDS; COVID; AKI
• Interventions: Device: SCD

• Registration Number: NCT04395911
• Lead Sponsor: SeaStar Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Start: 2020-09-10
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCD	SCD	Cytopheretic device

Primary Outcome Measures

Name	Time	Method
Dialysis Dependency	60 days post treatment	Dialysis Dependency at Day 60
Mortality at Day 60	60 days post treatment	All cause mortality at Day 60
Ventilation at Day 28	28 days post treatment	Ventilation free survival at Day 28

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States