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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2021-07-21

Brief Summary

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Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.

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Detailed Description

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Conditions

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AKI ARDS COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCD

Cytopheretic device

Group Type OTHER

SCD

Intervention Type DEVICE

cytopheretic device

Interventions

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SCD

cytopheretic device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No