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Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19
Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19

NCT04547257

Active Not RecruitingNA

Sponsor: ExThera Medical Corporation

Conditions: COVID-19

Interventions: Seraph 100

Countries: Germany, Spain

Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

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 Child-Pugh Class C cirrhosis
5. Have platelet count \<30.000/uL
6. Contraindications for heparin sodium for injection
7. Subjects demonstrating any contraindication for this treatment as described in the IFU
8. Subjects with known allergy of polyethylene and copolyester
9. Subjects with hospital-acquired SARS-CoV-2 infections
10. Subject is held in an institution by court or official order
11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Locations (5)
  • Aschaffenburg, Germany
  • Berlin, Germany
  • Essen, Germany
  • Barcelona, Spain
  • Madrid, Spain