Plasma Adsorption in Patients With Confirmed COVID-19

Marker Therapeutics

Status: Completed

Conditions: Respiratory Failure; ARDS

Treatments: Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04358003

MH-007/B

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Plasma Adsorption Cartridge

Experimental group

Description:

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.

Treatment:

Device: Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)