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

• Sponsor: Hannover Medical School (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04361500
• Collaborator: Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 17.5
• Patients Per Site: 50
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Device: Seraph 100

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Apr 15, 2020
• Anticipated Primary Completion Date: Oct 1, 2020
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Survival [30 days]

   Overall Survival after Seraph 100 therapy session

Secondary Outcome Measures

1. Length of ICU stay [30 days]

   Time spend in the ICU after Seraph 100 therapy session

2. Length of Hospital stay [30 days]

   Time spend in the hospital after Seraph 100 therapy session

3. Length of ventilator therapy [30 days]

   Time spend on ventilator after Seraph 100 therapy session

4. Adverse events [30 days]

   Report of any Seraph 100 therapy related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• COVID-19 infection

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

• Voluntary consent to participate in Registry

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Teaching Hospital Brunswick	Brunswick	Lower Saxony	Germany
2	Hannover Medical School	Hannover		Germany

Sponsors and Collaborators

• Hannover Medical School
• Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hannover Medical School
• ClinicalTrials.gov Identifier: NCT04361500
• Other Study ID Numbers: COSA-8998
• First Posted: Apr 24, 2020
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 24, 2020