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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: COVID-19; SARS-CoV 2

Treatments: Device: Seraph®-100 Microbind® Affinity Blood Filter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04413955

001-Seraph®-100 for SARS-CoV-2

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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