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Plasma Adsorption in Patients With Confirmed COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358003
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Marker Therapeutics AG

Tracking Information
First Submitted Date  ICMJE April 20, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE May 20, 2020
Actual Primary Completion Date November 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
All-cause mortality [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
Change in Sequential Organ Failure Assessment [SOFA] scores [ Time Frame: Day 28 ]
Scale of 0-24 with a higher number indicating a worse outcome
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
Change in SOFA scores [ Time Frame: Day 28 ]
Change in sequential organ failure assessment scores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plasma Adsorption in Patients With Confirmed COVID-19
Official Title  ICMJE Plasma Adsorption in Patients With Confirmed COVID-19 Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Failure
  • ARDS
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2022)
107
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2020)
2000
Actual Study Completion Date  ICMJE April 1, 2022
Actual Primary Completion Date November 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04358003
Other Study ID Numbers  ICMJE MH-007/B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Marker Therapeutics AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Marker Therapeutics AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Terumo BCT
Investigators  ICMJE Not Provided
PRS Account Marker Therapeutics AG
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP