Name (Synonyms) | Correlation | |
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D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
Description: 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
Measure: Rate of known, expected, or unanticipated adverse device effects Time: From the initiation of therapy through 24 hours after therapy has been completedDescription: Measure change in Mean Arterial Pressure before and after treatment with the Seraph®-100 device
Measure: Change in cardiovascular hemodynamic stability Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in required Vasopressor Dosages before and after treatment with the Seraph®-100 device
Measure: Change in cardiovascular hemodynamic support Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in required Respiratory Support before and after treatment with the Seraph®-100 device
Measure: Change in pulmonary/respiratory status Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in Interleukin-6 (IL-6) before and after treatment with the Seraph®-100 device
Measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: IL-6 Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in C-Reactive Protein (CRP) before and after treatment with the Seraph®-100 device
Measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: CRP Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in Ferritin before and after treatment with the Seraph®-100 device
Measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: Ferritin Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in D-Dimer before and after treatment with the Seraph®-100 device
Measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: D-Dimer Time: 24 hours prior to therapy through 24 hours after therapy has been completedDescription: Measure change in Absolute Lymphocyte Count (ALC) before and after treatment with the Seraph®-100 device
Measure: Change in laboratory measures of cytokine reactions and/or viral sepsis: ALC Time: 24 hours prior to therapy through 24 hours after therapy has been completed