NCT04606498: PURIFY-OBS-1

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

Status unknown Last updated 1 November 2022

What this trial tests

trial testing Observational in Covid19 in 200 participants. Status unknown.

Timeline

18 December 2020

Primary endpoint
31 October 2022

1 January 2023

Quick facts

Lead sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	18 December 2020
Primary completion	31 October 2022
Estimated completion	1 January 2023
Sites	14 locations across United States

Drugs / interventions tested

• Observational — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rationale for sequential extracorporeal therapy (SET) in sepsis.
   Ronco C, Chawla L, Husain-Syed F, Kellum JA. · · 2023 · cited 47× · PMID 36750878 · DOI 10.1186/s13054-023-04310-2
2. A Multicenter Evaluation of the Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19.
   Chitty SA, Mobbs S, Rifkin BS, Stogner SW, et al · · 2022 · cited 29× · PMID 35506015 · DOI 10.1097/cce.0000000000000662
3. Interim analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry.
   Schmidt JJ, Borchina DN, Van't Klooster M, Bulhan-Soki K, et al · · 2022 · cited 29× · PMID 34875087 · DOI 10.1093/ndt/gfab347
4. A Review of Extracorporeal Blood Purification Techniques for the Treatment of Critically Ill Coronavirus Disease 2019 Patients.
   Niazi NS, Nassar TI, Stewart IJ, Honore PM, et al · · 2022 · cited 18× · PMID 35417433 · DOI 10.1097/mat.0000000000001761
5. Expanding the potential therapeutic options of hemoperfusion in the era of improved sorbent biocompatibility.
   Damianaki A, Stambolliu E, Alexakou Z, Petras D. · · 2023 · cited 6× · PMID 37098671 · DOI 10.23876/j.krcp.22.223
6. Extracorporeal Blood Purification Is Appropriate in Critically Ill Patients with COVID-19 and Multiorgan Failure: PRO.
   Chung KK, Olson SW. · · 2022 · cited 3× · PMID 35582175 · DOI 10.34067/kid.0006632020
7. The Seraph 100^® Microbind Affinity Blood Filter Does Not Alter Levels of Circulating or Mucosal Antibodies in Critical COVID-19 Patients.
   Conner TL, Vir P, Laing ED, Stewart IJ, et al · · 2024 · PMID 39189236 · DOI 10.3390/antib13030065
8. Interim-analysis of the COSA (COVID-19 Patients Treated With the Seraph® 100 Microbind® Affinity Filter) Registry
   Schmidt JJ, Borchina DN, Klooster Mv, Soki K, et al · · 2021 · DOI 10.21203/rs.3.rs-557453/v1