Plasma Adsorption in Patients With Confirmed COVID-19

Completed · Not applicable

Conditions studied: Respiratory Failure, ARDS

In brief

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.

Key facts

Study ID

NCT04358003

Run by

Marker Therapeutics AG

People needed

107

Starts

2020-05-20

Expected to finish

2022-04-01

Last updated by the study team

2022-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Admitted to ICU
• Diagnosis of SARS-CoV-2 with any one of the following conditions:
• Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• Severe disease, defined as:
• dyspnea,
• respiratory frequency ≥ 30/min
• blood oxygen saturation ≤ 93%
• partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
• lung infiltrates > 50% within 24 to 48 hours; or
• Life-threatening disease, defined as:
• respiratory failure,
• septic shock, and/or
• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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