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

NCT04395911 | Completed FDA Device

• 1 other identifier: SCD-005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

AKI; ARDS; COVID

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Dialysis Dependency

  28 days post treatment

• Mortality at Day 28

  28 days post treatment

• Urinary output change

  10 days of treatment

• P02/FiO2 change

  10 days of treatment

• Safety Assessments

  10 days of treatment

Study Arms (1)

SCD

OTHER

Cytopheretic device

Device: SCD

Interventions

SCD DEVICE

cytopheretic device

SCD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SeaStar Medical: lead

Study Sites (3)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 20, 2020
• Study Start: September 10, 2020
• Primary Completion: July 5, 2021
• Study Completion: July 21, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be collected throughout the study conduct.
• Access Criteria: 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.

Locations

US (3)