Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study

Status unconfirmed

Conditions studied: Covid19

In brief

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

Key facts

Study ID

NCT04606498

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

200

Starts

2020-12-18

Expected to finish

2023-01-01

Last updated by the study team

2022-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prospective Seraph® 100
• Subject must be 18 years of age
• Per the FDA Approve EUA:
• Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:
• Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• Severe disease, defined as:
• Dyspnea,
• Respiratory frequency ≥ 30/min,
• 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; or
• Life-threatening disease, defined as:
• Respiratory failure,
• Septic shock, and/or
• Multiple organ dysfunction or failure. 2. Prospective study patients (or their Legally Authorized Representative (LAR)) provides informed consent. Patients or their legally authorized representative will be consented in their main language if they are not fluent in English.
• Prospective study patient is willing to complete all study visits as required by the protocol 4. For Military Treatment Facility (MTF) enrollment only - must be DEERS eligible for care at the MTF
• Retrospective Seraph® 100
• Subject must be 18 years of age
• Per the FDA Approve EUA:
• Subject must have confirmed COVID-19 infection and be admitted to the ICU with confirmed or imminent respiratory failure and any one of the following conditions:
• Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
• Severe disease, defined as:
• Dyspnea,
• Respiratory frequency ≥ 30/min,
• Blood oxygen saturation ≤ 93%,

You may not qualify if…

• Prospective
• Unwilling to provide informed consent
• Unable to provide informed consent and no LAR available to provide permission
• Retrospective No specific exclusion criteria. However, patients treated with Seraph® 100 prior to approval of the study at a site and who remains admitted to the hospital at the time the study is approved, will be given the opportunity to participate in the study by signing consent for their health data to be collected (and not biospecimens).
• Historical Controls:
• Patients who remain admitted to the hospital at the time that the study is approved at the study site will be excluded.

Where it is running

• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Advent Health — Orlando, Florida, United States
• Southeast Georgia Health System - Brunswick Campus — Brunswick, Georgia, United States
• Eisenhower Army Medical Center (EAMC) — Fort Gordon, Georgia, United States
• Ian Stewart — Bethesda, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Forrest General Hospital — Hattiesburg, Mississippi, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Baylor Scott & White — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Methodist Hospital — San Antonio, Texas, United States
• University Of Texas Health San Antonio (UTHSA)- University Health — San Antonio, Texas, United States
• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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