Clinical trial NCT04395911: 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
Overall status: COMPLETED
Phase: NA
Conditions: AKI
ARDS
COVID
Lead sponsor: SeaStar Medical
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mortality at Day 60
timeFrame: 60 days post treatment
measure: Dialysis Dependency
timeFrame: 60 days post treatment
measure: Ventilation at Day 28
timeFrame: 28 days post treatment
Secondary outcomes:
measure: Dialysis Dependency
timeFrame: 28 days post treatment
measure: Mortality at Day 28
timeFrame: 28 days post treatment
measure: Urinary output change
timeFrame: 10 days of treatment
measure: P02/FiO2 change
timeFrame: 10 days of treatment
measure: Safety Assessments
timeFrame: 10 days of treatment
measure: SCD Integrity
timeFrame: 10 days of treatment
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: