Plasma Adsorption in Patients With Confirmed COVID-19
1 other identifier
interventional
107
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedStudy Start
First participant enrolled
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 11, 2022
April 1, 2022
1.5 years
April 20, 2020
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
Day 28
Secondary Outcomes (1)
Change in Sequential Organ Failure Assessment [SOFA] scores
Day 28
Study Arms (1)
Plasma Adsorption Cartridge
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marker Therapeutics AGlead
- Terumo BCTcollaborator
Study Sites (7)
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205, United States
UNM Health Science Center
Albuquerque, New Mexico, 87131, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
UT Southwestern/Clements Hospital
Dallas, Texas, 75390, United States
UTMB
Galveston, Texas, 77550, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Related Publications (1)
Choi C, De Simone N, Webb CB, Lahsaei P, Yates SG, Raval JS, Harkins MS, Hillebrand DJ, Belli A, Schlapobersky NA, Ipe TS, Banez-Sese GC, Khangoora VS, Nathan SD, Demko TM, Young DC, Caron S, Sarode R. Plasma Adsorption with the MTx.100 Column in Critically Ill COVID-19 Patients: A Prospective Study and Propensity Score Analysis. J Intensive Care Med. 2025 Mar;40(3):314-319. doi: 10.1177/08850666241280031. Epub 2024 Sep 12.
PMID: 39267408DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 22, 2020
Study Start
May 20, 2020
Primary Completion
November 26, 2021
Study Completion
April 1, 2022
Last Updated
April 11, 2022
Record last verified: 2022-04