Plasma Adsorption in Patients With Confirmed COVID-19

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

More Information

• Responsible Party: Marker Therapeutics AG
• ClinicalTrials.gov Identifier: NCT04358003
• Other Study ID Numbers: MH-007/B
• First Posted: April 22, 2020
• Last Update Posted: February 23, 2021
• Last Verified: February 2021

• 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:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Coal Tar; Keratolytic Agents; Dermatologic Agents