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Plasma Adsorption in Patients With Confirmed COVID-19

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ClinicalTrials.gov Identifier: NCT04358003
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Marker Therapeutics AG

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure ARDS Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasma Adsorption in Patients With Confirmed COVID-19 Infection
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Coal Tar

Arm Intervention/treatment
Experimental: 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.
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 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 Measures :
  1. All-cause mortality [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Change in Sequential Organ Failure Assessment [SOFA] scores [ Time Frame: Day 28 ]
    Scale of 0-24 with a higher number indicating a worse outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358003


Contacts
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Contact: Eeke Romo, MD 1-877-339-4228 eua@markerhealth.com

Locations
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United States, New Mexico
UNM Health Science Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Jay Raval, MD    505-925-7765      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Jason Wells, MD    503-963-3030      
United States, Texas
UT Southwestern/Clements Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Nicole De Simone, MD    214-633-4923      
UTMB Recruiting
Galveston, Texas, United States, 77550
Contact: Sean Yates, MD    409-772-1978      
United States, Virginia
Inova Fairfax Medical Campus Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Vikramjit Khangoora, MD    703-776-4001      
Sponsors and Collaborators
Marker Therapeutics AG
Terumo BCT
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Responsible Party: Marker Therapeutics AG
ClinicalTrials.gov Identifier: NCT04358003    
Other Study ID Numbers: MH-007/B
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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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
Keywords provided by Marker Therapeutics AG:
SARS-CoV-2
COVID-19
Spectra Optia Apheresis System
D2000 Cartridge
Terumo BCT
Marker Therapeutics
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Coal Tar
Keratolytic Agents
Dermatologic Agents