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

Completed

• Conditions: COVID-19; SARS-CoV 2

• Registration Number: NCT04413955
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study Start: 2020-06-01
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Confirmed COVID-19 infection

• Confirmed or imminent respiratory failure

• At least one of the following conditions

  1. Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)

  2. 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

  3. Life-threatening disease, defined as:

     • respiratory failure,
     • septic shock, and/or
     • multiple organ dysfunction or failure

Exclusion Criteria

• No Exclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of known, expected, or unanticipated adverse device effects	From the initiation of therapy through 24 hours after therapy has been completed	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

Secondary Outcome Measures

Name	Time	Method
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	Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device
Change in cardiovascular hemodynamic stability	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
Change in cardiovascular hemodynamic support	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device
Change in pulmonary/respiratory status	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in D-Dimer before and after treatment with the Seraph®-100 device
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	Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in Ferritin before and after treatment with the Seraph®-100 device
Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC	24 hours prior to therapy through 24 hours after therapy has been completed	Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States