ARDS, Respiratory Failure
Conditions
Keywords
SARS-CoV-2, COVID-19, Spectra Optia Apheresis System, D2000 Cartridge, Terumo BCT, Marker Therapeutics
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.
Interventions
DEVICEMarker 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.
Sponsors
Terumo BCT
Marker Therapeutics AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sequential Organ Failure Assessment [SOFA] scores | Day 28 | Scale of 0-24 with a higher number indicating a worse outcome |
Countries
United States
Outcome results
None listed