Status:

COMPLETED

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

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsors:

ExThera Medical Corporation

Conditions:

COVID-19

SARS-CoV 2

Eligibility:

All Genders

18+ years

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 ...

Eligibility Criteria

Inclusion

  • Confirmed COVID-19 infection
  • Confirmed or imminent respiratory failure
  • At least one of the following conditions
  • Early acute lung injury (ALI) or early acute respiratory distress syndrome (ARDS)
  • 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
  • Life-threatening disease, defined as:
  • respiratory failure,
  • septic shock, and/or
  • multiple organ dysfunction or failure

Exclusion

  • No Exclusion

Key Trial Info

Start Date :

June 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 31 2022

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04413955

Start Date

June 1 2020

End Date

January 31 2022

Last Update

February 13 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229