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

• ClinicalTrials.gov Identifier: NCT04395911
• Recruitment Status: Completed
• First Posted: May 20, 2020
• Last Update Posted: August 5, 2021
• Sponsor: SeaStar Medical
• Information provided by (Responsible Party): SeaStar Medical

Tracking Information

• First Submitted Date: May 17, 2020
• First Posted Date: May 20, 2020
• Last Update Posted Date: August 5, 2021
• Actual Study Start Date: September 10, 2020
• Actual Primary Completion Date: July 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 18, 2020)

• Mortality at Day 60 [ Time Frame: 60 days post treatment ]
  All cause mortality at Day 60
• Dialysis Dependency [ Time Frame: 60 days post treatment ]
  Dialysis Dependency at Day 60
• Ventilation at Day 28 [ Time Frame: 28 days post treatment ]
  Ventilation free survival at Day 28

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 18, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• AKI
• ARDS
• COVID

Intervention

Device: SCD

cytopheretic device

Study Arms

SCD

Cytopheretic device

Intervention: Device: SCD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2021): 22
• Original Estimated Enrollment (submitted: May 18, 2020): 35
• Actual Study Completion Date: July 21, 2021
• Actual Primary Completion Date: July 5, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04395911
• Other Study ID Numbers: SCD-005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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.

• Responsible Party: SeaStar Medical
• Study Sponsor: SeaStar Medical
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: SeaStar Medical
• Verification Date: August 2021