COVID-19
Conditions
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.
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.
Interventions
DEVICESeraph 100
Seraph 100 therapy during a COVID-19 infection
Sponsors
Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick
Hannover Medical School
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 30 days | Overall Survival after Seraph 100 therapy session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | 30 days | Time spend in the ICU after Seraph 100 therapy session |
| Length of Hospital stay | 30 days | Time spend in the hospital after Seraph 100 therapy session |
| Length of ventilator therapy | 30 days | Time spend on ventilator after Seraph 100 therapy session |
| Adverse events | 30 days | Report of any Seraph 100 therapy related adverse events |
Countries
Germany
Contacts
Primary ContactJulius J Schmidt, Dr
Backup ContactJan T Kielstein, Prof
Outcome results
None listed