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

NCT04413955 | Completed FDA Device

• 1 other identifier: 001-Seraph®-100 for SARS-CoV-2
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

• Rate of known, expected, or unanticipated adverse device effects

  Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction

  From the initiation of therapy through 24 hours after therapy has been completed

Secondary Outcomes (8)

• Change in cardiovascular hemodynamic stability

  24 hours prior to therapy through 24 hours after therapy has been completed

• Change in cardiovascular hemodynamic support

  24 hours prior to therapy through 24 hours after therapy has been completed

• Change in pulmonary/respiratory status

  24 hours prior to therapy through 24 hours after therapy has been completed

• Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6

  24 hours prior to therapy through 24 hours after therapy has been completed

• Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP

  24 hours prior to therapy through 24 hours after therapy has been completed

Interventions

Seraph®-100 Microbind® Affinity Blood Filter DEVICE

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

Also known as: Seraph

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients in intensive care units in the US

You may qualify if:

• Confirmed COVID-19 infection
• Confirmed or imminent respiratory failure
• At least one of the following conditions
• Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)
• Severe disease, defined as:
• dyspnea,
• respiratory frequency ≥ 30 bpm,
• blood oxygen saturation ≤ 93%,
• partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
• lung infiltrates \> 50% within 24 to 48 hours
• Life-threatening disease, defined as:
• respiratory failure,
• septic shock, and/or
• multiple organ dysfunction or failure

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• ExThera Medical Corporation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Sun X, Yang S, Al-Dossary AA, Broitman S, Ni Y, Guan M, Yang M, Li J. Nanobody-Functionalized Cellulose for Capturing SARS-CoV-2. Appl Environ Microbiol. 2022 Mar 8;88(5):e0230321. doi: 10.1128/aem.02303-21. Epub 2022 Jan 5.

  PMID: 34985974 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1)