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

COVID Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395911
• Other study ID #: SCD-005
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: July 21, 2021

Study information

• Verified date: August 2021
• Source: SeaStar Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 21, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• AKI
• ARDS
• COVID
• Infection

Intervention

Device:
• SCD
cytopheretic device

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
SeaStar Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at Day 60	All cause mortality at Day 60	60 days post treatment
Primary	Dialysis Dependency	Dialysis Dependency at Day 60	60 days post treatment
Primary	Ventilation at Day 28	Ventilation free survival at Day 28	28 days post treatment
Secondary	Dialysis Dependency	Dialysis Dependency at Day 28	28 days post treatment
Secondary	Mortality at Day 28	All cause mortality at Day 28	28 days post treatment
Secondary	Urinary output change	Change from baseline in urine output	10 days of treatment
Secondary	P02/FiO2 change	Change from baseline in PO2/FiO2	10 days of treatment
Secondary	Safety Assessments	Assessment of SAEs, AE and UADEs	10 days of treatment
Secondary	SCD Integrity	Assessment of device performance	10 days of treatment