Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 SARS-CoV 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Seraph

Eligibility Criteria

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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