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

COVID-19 Clinical Trial

— COSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04361500
• Other study ID #: COSA-8998
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2020
• Source: Hannover Medical School
• Contact: Julius J Schmidt, Dr
• Phone: +495115326319
• Email: schmidt.julius[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• COVID-19 infection

• Treatment with the Seraph® 100 Microbind® Affinity Blood Filter

• Voluntary consent to participate in Registry

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Seraph 100
Seraph 100 therapy during a COVID-19 infection

Locations

Country	Name	City	State
Germany	Academic Teaching Hospital Brunswick	Brunswick	Lower Saxony
Germany	Hannover Medical School	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall Survival after Seraph 100 therapy session	30 days
Secondary	Length of ICU stay	Time spend in the ICU after Seraph 100 therapy session	30 days
Secondary	Length of Hospital stay	Time spend in the hospital after Seraph 100 therapy session	30 days
Secondary	Length of ventilator therapy	Time spend on ventilator after Seraph 100 therapy session	30 days
Secondary	Adverse events	Report of any Seraph 100 therapy related adverse events	30 days