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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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229