Registry of COVID-19 Patients Treated With the Seraph 100 Microbind Affinity Blood Filter

• Conditions: COVID-19
• Interventions: Device: Seraph 100

• Registration Number: NCT04361500
• Lead Sponsor: Hannover Medical School

Brief Summary

The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.

Detailed Description

During the ongoing COVID-19 pandemic, millions of people have been infected with SARS- Cov-2 worldwide. In the absence of an approved vaccine or medical treatment, there is an emerging need for treatment options, especially in critically ill patients. Multiple pharmacological and non-pharmacological therapies are being investigated. In 2019, the Seraph® 100 Microbind® Affinity Blood Filter (ExThera Medical Corporation, CA, USA) was approved for the removal of pathogens in Europe. On April 17th the FDA granted Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-15
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• COVID-19 infection
• Treatment with the Seraph® 100 Microbind® Affinity Blood Filter
• Voluntary consent to participate in Registry

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients with Seraph 100 therapy	Seraph 100	-

Primary Outcome Measures

Name	Time	Method
Survival	30 days	Overall Survival after Seraph 100 therapy session

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	30 days	Time spend in the ICU after Seraph 100 therapy session
Length of Hospital stay	30 days	Time spend in the hospital after Seraph 100 therapy session
Length of ventilator therapy	30 days	Time spend on ventilator after Seraph 100 therapy session
Adverse events	30 days	Report of any Seraph 100 therapy related adverse events

Trial Locations

Locations (2)

Academic Teaching Hospital Brunswick; 🇩🇪 Brunswick, Lower Saxony, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany