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Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA

NCT04413955 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-02-13

No results posted yet for this study

Summary

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients.

Conditions

Interventions

DEVICE

Seraph®-100 Microbind® Affinity Blood Filter

Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood

Sponsors & Collaborators

  • ExThera Medical Corporation

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-12-31
Completion
2022-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04413955 on ClinicalTrials.gov