NCT04361500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 22, 2020

Last Update Submit

April 22, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Survival

    Overall Survival after Seraph 100 therapy session

    30 days

Secondary Outcomes (4)

  • Length of ICU stay

    30 days

  • Length of Hospital stay

    30 days

  • Length of ventilator therapy

    30 days

  • Adverse events

    30 days

Study Arms (1)

COVID-19 patients with Seraph 100 therapy

Device: Seraph 100

Interventions

Seraph 100DEVICE

Seraph 100 therapy during a COVID-19 infection

COVID-19 patients with Seraph 100 therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academic Teaching Hospital Brunswick

Braunschweig, Lower Saxony, Germany

RECRUITING

Hannover Medical School

Hanover, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Julius J Schmidt, Dr

CONTACT

+495115326319schmidt.julius@mh-hannover.de

Jan T Kielstein, Prof

CONTACT

+495315952380kielstein@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

April 15, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)