NCT04361500

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DEVICE	Seraph 100	Seraph 100 therapy during a COVID-19 infection

Timeline

• Start date: 2020-04-15
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated device study