NCT04358003CompletedNot Applicable
Plasma Adsorption in Patients With Confirmed COVID-19 Infection
Marker Therapeutics AG14 sites in 1 country107 target enrollmentStarted: May 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 107
- Locations
- 14
- Primary Endpoint
- All-cause mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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.
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
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: Day 28
Secondary Outcomes
- Change in Sequential Organ Failure Assessment [SOFA] scores(Day 28)
Investigators
Study Sites (14)
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