Registry of COVID-19 Patients Treated With the Seraph 100... | NCT04361500

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

NCT04361500

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Seraph 100

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Actual

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Oct 1, 2021Estimated

First Submitted Date

Apr 22, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Name	Class
Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 patients with Seraph 100 therapy			Device: Seraph 100

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seraph 100	Device	Seraph 100 therapy during a COVID-19 infection	COVID-19 patients with Seraph 100 therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Overall Survival after Seraph 100 therapy session	30 days

Secondary Outcomes

Measure	Description	Time Frame
Length of ICU stay	Time spend in the ICU after Seraph 100 therapy session	30 days
Length of Hospital stay	Time spend in the hospital after Seraph 100 therapy session

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with prooven COVID-19 infection with confirmed or imminent respiratory failure and Treatment with the Seraph® 100 Microbind® Affinity Blood Filter.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julius J Schmidt, Dr	Contact	+495115326319		schmidt.julius@mh-hannover.de
Jan T Kielstein, Prof	Contact	+495315952380		kielstein@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Teaching Hospital Brunswick	Recruiting	Braunschweig	Lower Saxony		Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided