Plasma Adsorption in Patients With Confirmed COVID-19

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

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-04-01

Brief Summary

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To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.

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Detailed Description

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Conditions

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Respiratory Failure ARDS

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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Plasma Adsorption Cartridge

Subjects will receive one treatment per day with the D2000 Cartridge for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) for up to 4 hours (treatment cycle) for up to seven (7) days.

Group Type EXPERIMENTAL

Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

Intervention Type DEVICE

Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected.

Study Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician.

Interventions

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Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected.

Study Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* Admitted to ICU
* Diagnosis of SARS-CoV-2 with any one of the following conditions:

1. Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
2. Severe disease, defined as:

1. dyspnea,
2. respiratory frequency ≥ 30/min
3. blood oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
5. lung infiltrates \> 50% within 24 to 48 hours; or
3. Life-threatening disease, defined as:

1. respiratory failure,
2. septic shock, and/or
3. multiple organ dysfunction or failure.
* Patient fact sheet is provided to the subject.
* Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.

Exclusion Criteria

* Treatment limitation or a do not attempt to resuscitate in place
* Pregnancy
* Significant or uncontrolled bleeding
* In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No