Plasma Adsorption in Patients With Confirmed COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; ARDS
• Intervention / Treatment: Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences (UAMS)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • UNM Health Science Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Clements Hospital
    • Galveston, Texas, United States, 77550
      • UTMB
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sequential Organ Failure Assessment [SOFA] scores	Scale of 0-24 with a higher number indicating a worse outcome	Day 28

Collaborators and Investigators

• Sponsor: Marker Therapeutics AG
• Collaborators: Terumo BCT

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): November 26, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Spectra Optia Apheresis System; D2000 Cartridge; Terumo BCT; Marker Therapeutics
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: MH-007/B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes