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

Purpose

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.

Conditions

  • COVID-19
  • SARS-CoV 2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT04413955
Status
Enrolling by invitation
Sponsor
Children's Hospital Medical Center, Cincinnati