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Clinical Trials in Spain / NCT04547257
Active, not recruiting Not applicable

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

NCT04547257 · tracked via the Priya Life Science Spain tracker
Sponsor
ExThera Medical Corporation
Phase
Not applicable
Started
2021-05-04
Last updated
2026-04-20

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Seraph 100

Seraph 100: Bloodfiltration with Seraph 100

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Klinikum Aschaffenburg-Alzenau Aschaffenburg Germany
Vivantes Klinikum Neukölln Berlin Germany
Universitätsklinikum Essen Essen Germany
Hospital Universitari Vall d'Hebron Barcelona Spain
Hospital Clinico San Carlos Madrid Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04547257 on ClinicalTrials.gov ↗ ← All trials in Spain