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

Enrolling by invitation
COVID-19
SARS-CoV 2

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States

ExThera Medical Corporation
NCT Number
MeSH Terms
COVID-19