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

April 22, 2020 updated by: Hannover Medical School

Registry for the Evaluation of Safety and Effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the Therapy of COVID-19 Patients (COSA)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hannover, Germany
        • Recruiting
        • Hannover Medical School
        • Contact:
        • Principal Investigator:
          • Julius J Schmidt
        • Sub-Investigator:
          • Bernhard MW Schmidt
    • Lower Saxony
      • Brunswick, Lower Saxony, Germany
        • Recruiting
        • Academic Teaching Hospital Brunswick
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 patients with Seraph 100 therapy
Device: Seraph 100
Seraph 100 therapy during a COVID-19 infection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: 30 days
Time spend in the ICU after Seraph 100 therapy session
30 days
Length of Hospital stay
Time Frame: 30 days
Time spend in the hospital after Seraph 100 therapy session
30 days
Length of ventilator therapy
Time Frame: 30 days
Time spend on ventilator after Seraph 100 therapy session
30 days
Adverse events
Time Frame: 30 days
Report of any Seraph 100 therapy related adverse events
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2020

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSA-8998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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