Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study
NCT04606498 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2022-11-01
Summary
This is a multi-center, observational study that will enroll 1) patients with severe COVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2) patients (medical record data) that have been previously treated with the Seraph® 100 after the date of the EUA approval (17 April 2020), but before the date that the study is approved at the study site, and 3) a convenience sample of patients (medical record data) in a historical control group who were admitted to the ICU at participating sites with severe COVID-19 infection, meeting the EUA treatment criteria, but not treated with Seraph® 100 up to the time the PURIFY-OBS protocol is approved at the site
Conditions
- Covid19
Interventions
- OTHER
-
Observational
Observational study only - no intervention
Sponsors & Collaborators
-
Uniformed Services University of the Health Sciences
collaborator FED -
Henry M. Jackson Foundation for the Advancement of Military Medicine
lead OTHER
Principal Investigators
-
Ian Stewart, MD · USUHS/WRNMMC
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-18
- Primary Completion
- 2022-10-31
- Completion
- 2023-01-01
Countries
- United States
Study Locations
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