Respiratory FailureNCT04358003
Plasma Adsorption in Patients With Confirmed COVID-19
A study testing Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) in people with Respiratory Failure and ARDS, run by Marker Therapeutics AG at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, ARDS
- What is being tested?
- Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 May 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UNM Health Science Center
Albuquerque, New Mexico, 87131
UT Southwestern/Clements Hospital
Dallas, Texas, 75390
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
UTMB
Galveston, Texas, 77550
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
Providence Portland Medical Center
Portland, Oregon, 97213
Reading Hospital
West Reading, Pennsylvania, 19611
About this study
Official title: Plasma Adsorption in Patients With Confirmed COVID-19 Infection
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.
- Conditions
- Respiratory Failure, ARDS
- Being tested
- Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
- Keywords
- SARS-CoV-2, COVID-19, Spectra Optia Apheresis System, D2000 Cartridge, Terumo BCT, Marker Therapeutics
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)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.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Adsorption Cartridge | Experimental | 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. Receives: Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: Day 28
Secondary outcomes (1)
Change in Sequential Organ Failure Assessment [SOFA] scores
Scale of 0-24 with a higher number indicating a worse outcome
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start20 May 2020
- Primary completion26 Nov 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marker Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Terumo BCT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358003
- Sponsor's protocol ID
- MH-007/B
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 39267408
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Adsorption in Patients With Confirmed COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04358003
- Acronym / sponsor ID
- MH-007/B
- Conditions
- Respiratory Failure, ARDS
- Keywords
- SARS-CoV-2, COVID-19, Spectra Optia Apheresis System, D2000 Cartridge, Terumo BCT, Marker Therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Marker Therapeutics AGIndustry (pharma, biotech, devices)
- Collaborators
- Terumo BCT
- Study start
- 20 May 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma Adsorption Cartridge | Experimental | Device: 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 use with the Spectra Optia® Apheresis System (Optia SPD Protocol) for up to 4 hours (treatment cycle) for up to seven (7) days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years old
- Admitted to ICU
- Diagnosis of SARS-CoV-2 with any one of the following conditions:
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Plasma Adsorption Cartridge |
Primary outcome
All-cause mortality
Time frame: Day 28
1 secondary outcome
Change in Sequential Organ Failure Assessment [SOFA] scores
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 39267408Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) in people with Respiratory Failure and ARDS, run by Marker Therapeutics AG at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.