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

Sponsor
SeaStar Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT04395911
Collaborator
(none)
22
Enrollment
3
Locations
1
Arm
10.3
Actual Duration (Months)
7.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SCD
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 10, 2020
Actual Primary Completion Date :
Jul 5, 2021
Actual Study Completion Date :
Jul 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: SCD

Cytopheretic device

Device: SCD
cytopheretic device

Outcome Measures

Primary Outcome Measures

  1. Mortality at Day 60 [60 days post treatment]

    All cause mortality at Day 60

  2. Dialysis Dependency [60 days post treatment]

    Dialysis Dependency at Day 60

  3. Ventilation at Day 28 [28 days post treatment]

    Ventilation free survival at Day 28

Secondary Outcome Measures

  1. Dialysis Dependency [28 days post treatment]

    Dialysis Dependency at Day 28

  2. Mortality at Day 28 [28 days post treatment]

    All cause mortality at Day 28

  3. Urinary output change [10 days of treatment]

    Change from baseline in urine output

  4. P02/FiO2 change [10 days of treatment]

    Change from baseline in PO2/FiO2

  5. Safety Assessments [10 days of treatment]

    Assessment of SAEs, AE and UADEs

  6. SCD Integrity [10 days of treatment]

    Assessment of device performance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40506
2 University of Michigan Ann Arbor Michigan United States 48109
3 Henry Ford Health System Detroit Michigan United States 48202

Sponsors and Collaborators

  • SeaStar Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SeaStar Medical
ClinicalTrials.gov Identifier:
NCT04395911
Other Study ID Numbers:
  • SCD-005
First Posted:
May 20, 2020
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 5, 2021