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.
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
Other Name: Seraph
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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States