NCT04358003|CompletedFDA Device
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Sponsor study identifier
interventional
107
1 country
7
Study Start
May 20, 2020
Actual (reported)Primary Completion
November 26, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2020
Actual (reported)April 22, 2020
Actual (reported)May 20, 2020
Actual (reported)November 26, 2021
Actual (reported)April 1, 2022
Actual (reported)All-cause mortality
Day 28
Change in Sequential Organ Failure Assessment [SOFA] scores
Day 28
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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.
107 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2020
First Posted
April 22, 2020
Study Start
May 20, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 26, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Last Updated
April 11, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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