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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

Tracking Information
First Submitted Date  ICMJE May 17, 2020
First Posted Date  ICMJE May 20, 2020
Last Update Posted Date August 5, 2021
Actual Study Start Date  ICMJE September 10, 2020
Actual Primary Completion Date July 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • AKI
  • ARDS
  • COVID
Intervention  ICMJE Device: SCD
cytopheretic device
Study Arms  ICMJE SCD
Cytopheretic device
Intervention: Device: SCD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2021)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2020)
35
Actual Study Completion Date  ICMJE July 21, 2021
Actual Primary Completion Date July 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04395911
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE SeaStar Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SeaStar Medical
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP