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

Study Overview
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Brief Summary
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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.

Official Title
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Seraph®-100 Microbind® Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry

Conditions
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COVID-19, SARS-CoV 2

Intervention / Treatment
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* Device: Seraph®-100 Microbind® Affinity Blood Filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No Exclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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