Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19 - CP022

ExThera Medical Corporation0 个研究点目标入组 42 人开始时间: 2020年12月28日最近更新: 2024年8月19日

研究概览

暂无简介。

•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

发起方