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NCT04413955 · ClinicalTrials.gov registry record
Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 15
- Enrollment target
NCT04413955: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04413955 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413955 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study 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 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.
Primary Outcome
Monitor and report on adverse events and unanticipated adverse device effects experienced by patients receiving treatment with the Seraph®-100 for COVID-19, including but not limited to: bleeding, clotting, cardiac dysrhythmia, hypotension, increase in oxygen requirement, hemolytic anemia, and allergic/anaphylactic reaction
Interventions
- DEVICE Seraph®-100 Microbind® Affinity Blood Filter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-01-31 |
What the finished NCT04413955 record still lists
NCT04413955 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Seraph®-100 Microbind® Affinity Blood Filter is the first listed.
NCT04413955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04413955 about?
NCT04413955 is a clinical study titled "Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA". 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 pa...
What is the current status of trial NCT04413955?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2020-06-01. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT04413955?
The interventions under investigation include: Seraph®-100 Microbind® Affinity Blood Filter (DEVICE).
Who is sponsoring clinical trial NCT04413955?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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