Status:
COMPLETED
Plasma Adsorption in Patients With Confirmed COVID-19
Lead Sponsor:
Marker Therapeutics AG
Collaborating Sponsors:
Terumo BCT
Conditions:
Respiratory Failure
ARDS
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04358003
Start Date
May 20 2020
End Date
April 1 2022
Last Update
April 11 2022
Active Locations (7)
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1
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
2
UNM Health Science Center
Albuquerque, New Mexico, United States, 87131
3
Providence Portland Medical Center
Portland, Oregon, United States, 97213
4
Reading Hospital
West Reading, Pennsylvania, United States, 19611