Back to resultsSafety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
Primary Purpose
AKI, ARDS, COVID
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCD
Sponsored by
About this trial
This is an interventional treatment trial for AKI
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.
Sites / Locations
- University of Kentucky
- University of Michigan
- Henry Ford Health System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SCD
Arm Description
Cytopheretic device
Outcomes
Primary Outcome Measures
Mortality at Day 60
All cause mortality at Day 60
Dialysis Dependency
Dialysis Dependency at Day 60
Ventilation at Day 28
Ventilation free survival at Day 28
Secondary Outcome Measures
Dialysis Dependency
Dialysis Dependency at Day 28
Mortality at Day 28
All cause mortality at Day 28
Urinary output change
Change from baseline in urine output
P02/FiO2 change
Change from baseline in PO2/FiO2
Safety Assessments
Assessment of SAEs, AE and UADEs
SCD Integrity
Assessment of device performance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04395911
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaStar Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AKI, ARDS, COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCD
Arm Type
Other
Arm Description
Cytopheretic device
Intervention Type
Device
Intervention Name(s)
SCD
Intervention Description
cytopheretic device
Primary Outcome Measure Information:
Title
Mortality at Day 60
Description
All cause mortality at Day 60
Time Frame
60 days post treatment
Title
Dialysis Dependency
Description
Dialysis Dependency at Day 60
Time Frame
60 days post treatment
Title
Ventilation at Day 28
Description
Ventilation free survival at Day 28
Time Frame
28 days post treatment
Secondary Outcome Measure Information:
Title
Dialysis Dependency
Description
Dialysis Dependency at Day 28
Time Frame
28 days post treatment
Title
Mortality at Day 28
Description
All cause mortality at Day 28
Time Frame
28 days post treatment
Title
Urinary output change
Description
Change from baseline in urine output
Time Frame
10 days of treatment
Title
P02/FiO2 change
Description
Change from baseline in PO2/FiO2
Time Frame
10 days of treatment
Title
Safety Assessments
Description
Assessment of SAEs, AE and UADEs
Time Frame
10 days of treatment
Title
SCD Integrity
Description
Assessment of device performance
Time Frame
10 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
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