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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395911
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
SeaStar Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
AKI ARDS COVID Device: SCD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 10, 2020
Actual Primary Completion Date : July 5, 2021
Actual Study Completion Date : July 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
SCD
Cytopheretic device
 Device: SCD
cytopheretic device


Outcome Measures
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Primary Outcome Measures :
  1. Mortality at Day 60 [ Time Frame: 60 days post treatment ]
    All cause mortality at Day 60

  2. Dialysis Dependency [ Time Frame: 60 days post treatment ]
    Dialysis Dependency at Day 60

  3. Ventilation at Day 28 [ Time Frame: 28 days post treatment ]
    Ventilation free survival at Day 28


Secondary Outcome Measures :
  1. Dialysis Dependency [ Time Frame: 28 days post treatment ]
    Dialysis Dependency at Day 28

  2. Mortality at Day 28 [ Time Frame: 28 days post treatment ]
    All cause mortality at Day 28

  3. Urinary output change [ Time Frame: 10 days of treatment ]
    Change from baseline in urine output

  4. P02/FiO2 change [ Time Frame: 10 days of treatment ]
    Change from baseline in PO2/FiO2

  5. Safety Assessments [ Time Frame: 10 days of treatment ]
    Assessment of SAEs, AE and UADEs

  6. SCD Integrity [ Time Frame: 10 days of treatment ]
    Assessment of device performance


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395911


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
SeaStar Medical
More Information
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Responsible Party: SeaStar Medical
ClinicalTrials.gov Identifier: NCT04395911    
Other Study ID Numbers: SCD-005
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases