NCT04547257

Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19

Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: ExThera Medical Europe BV · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19

Detailed description

This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection. The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only). Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.

Conditions

• COVID-19

Interventions

Type	Name	Description
DEVICE	Seraph 100	Bloodfiltration with Seraph 100

Timeline

• Start date: 2021-05-04
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2020-09-14
• Last updated: 2022-01-06

Locations

5 sites across 2 countries: Germany, Spain

Regulatory

• FDA-regulated device study