Back to resultsPlasma Adsorption in Patients With Confirmed COVID-19
Primary Purpose
Respiratory Failure, ARDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring SARS-CoV-2, COVID-19, Spectra Optia Apheresis System, D2000 Cartridge, Terumo BCT, Marker Therapeutics
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Admitted to ICU
Diagnosis of SARS-CoV-2 with any one of the following conditions:
- Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
Severe disease, defined as:
- dyspnea,
- respiratory frequency ≥ 30/min
- blood oxygen saturation ≤ 93%
- partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
- lung infiltrates > 50% within 24 to 48 hours; or
Life-threatening disease, defined as:
- respiratory failure,
- septic shock, and/or
- 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
Sites / Locations
- University of Arkansas for Medical Sciences (UAMS)
- UNM Health Science Center
- Providence Portland Medical Center
- Reading Hospital
- UT Southwestern/Clements Hospital
- UTMB
- Inova Fairfax Medical Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plasma Adsorption Cartridge
Arm Description
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.
Outcomes
Primary Outcome Measures
All-cause mortality
Secondary Outcome Measures
Change in Sequential Organ Failure Assessment [SOFA] scores
Scale of 0-24 with a higher number indicating a worse outcome
Full Information
NCT ID
NCT04358003
First Posted
April 20, 2020
Last Updated
April 7, 2022
Sponsor
Marker Therapeutics AG
Collaborators
Terumo BCT
1. Study Identification
Unique Protocol Identification Number
NCT04358003
Brief Title
Plasma Adsorption in Patients With Confirmed COVID-19
Official Title
Plasma Adsorption in Patients With Confirmed COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marker Therapeutics AG
Collaborators
Terumo BCT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, ARDS
Keywords
SARS-CoV-2, COVID-19, Spectra Optia Apheresis System, D2000 Cartridge, Terumo BCT, Marker Therapeutics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma Adsorption Cartridge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change in Sequential Organ Failure Assessment [SOFA] scores
Description
Scale of 0-24 with a higher number indicating a worse outcome
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Admitted to ICU
Diagnosis of SARS-CoV-2 with any one of the following conditions:
Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
Severe disease, defined as:
dyspnea,
respiratory frequency ≥ 30/min
blood oxygen saturation ≤ 93%
partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
lung infiltrates > 50% within 24 to 48 hours; or
Life-threatening disease, defined as:
respiratory failure,
septic shock, and/or
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
Facility Information:
Facility Name
University of Arkansas for Medical Sciences (UAMS)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UNM Health Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
UT Southwestern/Clements Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UTMB
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Plasma Adsorption in Patients With Confirmed COVID-19
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