Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
- Conditions
- COVID-19
- Registration Number
- DRKS00022857
- Lead Sponsor
- ExThera Medical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
1. Subjects with confirmed SARS-CoV-2 infection
2. Be = 18 years old and = 90 years old
3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent
1. Subject is currently participating in another clinical investigation
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
4. Have neutropenia (absolute neutrophil count <500 cells/uL)
5. Have Child-Pugh Class C cirrhosis
6. Have platelet count <30.000/uL
7. Contraindications for heparin sodium for injection
8. Subjects demonstrating any contraindication for this treatment as described in the IFU
9. Subjects with known allergy of polyethylene and copolyester
10. Subjects with hospital-acquired SARS-CoV-2 infections
11. Subject is held in an institution by court or official order
12. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours
- Secondary Outcome Measures
Name Time Method Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 – 20, with higher scores indicating more dysfunction)<br>Time frame: [During ICU stay at 12h, 24h, 36h, 96h after treatment]<br><br>All-cause mortality<br>Time frame: [28 days]<br>• Organ dysfunction-free days<br>Time frame: [Daily during ICU stay]<br>• Reduction of Intensive Care Unit (ICU) complications<br>Time frame: [Daily during ICU stay]<br>• Ventilator-free days (VFDs)<br>Time frame: [Daily during ICU stay]<br>• Length of stay (LOS) at ICU and hospital ward<br>• Reduction of prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)<br>Time frame: [From baseline to 48 hours]