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

NCT ID: NCT04361500

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 patients with Seraph 100 therapy

Seraph 100

Intervention Type DEVICE

Seraph 100 therapy during a COVID-19 infection

Interventions

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Seraph 100

Seraph 100 therapy during a COVID-19 infection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- none
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick

UNKNOWN

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academic Teaching Hospital Brunswick

Braunschweig, Lower Saxony, Germany

Site Status RECRUITING

Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julius J Schmidt, Dr

Role: CONTACT

+495115326319

Jan T Kielstein, Prof

Role: CONTACT

+495315952380

Facility Contacts

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Jan T Kielstein, Prof

Role: primary

Julius J Schmidt, Dr

Role: primary

Other Identifiers

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COSA-8998

Identifier Type: -

Identifier Source: org_study_id

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