Blood Purification With Seraph 100 Microbind Affinity Blood Filter for Treatment of Severe COVID19 Observational Study
PURIFY-OBS-1
1 other identifier
observational
200
1 country
14
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedNovember 1, 2022
October 1, 2022
1.9 years
October 26, 2020
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time spent on medications used to increase blood pressure
list type of medication and length of medication for Blood pressure
Measure from start of medication (day 0) to day 28 of study
Secondary Outcomes (5)
Time spent on mechanical ventilation
From intubation date through extubation or day 28 of study
Time spent in the intensive care unit (ICU)
admission to ICU (day 0) through ICU discharge or up to day 28 of study
Time spent in the hospital
from hospital admission (day 0) to discharge or up to day 28
Time spent on dialysis
Start of dialysis treatment (day 0) to end of dialysis or up to day 28
Mortality
From diagnosis of Covid (day 0) to date of death up to day 28
Study Arms (3)
1- Retrospective
Retrospective Seraph® 100 - this group will be composed of subjects that were treated with 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. A waiver of informed consent will be requested from the Institutional Review Board (IRB) to allow the collection of these retrospective data
2 - Prospective
Prospective Seraph® 100 - To identify prospective Seraph® 100 patients, the individual site investigators will review currently admitted ICU patients for inclusion criteria and exclusion criteria. The study team will then ask the physician caring for the patient to contact the study team should the patient require therapy with Seraph® 100. Additionally, the study team will review the medical records of admitted patients to see if they have recently been started on Seraph. Patients found to meet eligibility will be offered the opportunity to consent and participate in the study. Note that patients that were started on Seraph® 100 before the date of approval but are still admitted, will not be eligible to give biospecimens.
3 - Historical Control
The historical control group will be a sample of convenience, composed of patients 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. A waiver of informed consent will be requested from the IRB to allow the collection of these retrospective data
Interventions
Observational study only - no intervention
Eligibility Criteria
This multi-center, observational study will attempt to recruit all patients treated with the Seraph® 100 under EUA #200165 in the United States at both civilian and military hospitals.
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.
- +34 more criteria
You may not qualify if:
- Prospective
- Unwilling to provide informed consent
- Unable to provide informed consent and no LAR available to provide permission
- Historical Controls:
- Patients who remain admitted to the hospital at the time that the study is approved at the study site will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Advent Health
Orlando, Florida, 32803, United States
Southeast Georgia Health System - Brunswick Campus
Brunswick, Georgia, 31520, United States
Eisenhower Army Medical Center (EAMC)
Fort Gordon, Georgia, 30905, United States
Ian Stewart
Bethesda, Maryland, 20814, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
Forrest General Hospital
Hattiesburg, Mississippi, 39401, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Baylor Scott & White
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
University Of Texas Health San Antonio (UTHSA)- University Health
San Antonio, Texas, 78229, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Biospecimen
Biospecimen (blood, urine, sputum, swabs) will be collected at D0, before initiation of extracorporeal treatment, and on study days 1, 2, 3, 4, 7, 28, and 90-180. Since a goal of this study is to recruit as many subjects as possible (predominantly for safety purposes), if a patient is started on Seraph® 100 prior to being recruited for the study, lab collection will begin at the next time point. For example, if a patient is started on Seraph® 100 on a Sunday and the patient is not enrolled until Monday, study day 0 labs will be marked as missing and lab collection will begin on study day 1.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Stewart, MD
USUHS/WRNMMC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 28, 2020
Study Start
December 18, 2020
Primary Completion
October 31, 2022
Study Completion
January 1, 2023
Last Updated
November 1, 2022
Record last verified: 2022-10