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

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

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

Study Overview

• Status: Completed
• Conditions: AKI; COVID; ARDS
• Intervention / Treatment: Device: SCD

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SCD; Cytopheretic device	Device: SCD; cytopheretic device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SeaStar Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SCD-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unidentified participant data collected for this study will be submitted to a CRO for data analysis. All data will be submitted to the Sponsor.
• IPD Sharing Time Frame: Data will be collected throughout the study conduct.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes