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.
Study Type
OBSERVATIONAL
Enrollment
15
Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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
Time frame: From the initiation of therapy through 24 hours after therapy has been completed
Change in cardiovascular hemodynamic stability
Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hours prior to therapy through 24 hours after therapy has been completed
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