COVID-19, SARS-CoV 2
Conditions
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.
Interventions
DEVICESeraph®-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
Sponsors
ExThera Medical Corporation
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 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: 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: 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 |
| 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 |
Countries
United States
Outcome results
None listed