The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) on February 2 announced a cooperative agreement with the Uniformed Services University of the Health Sciences (USU) to work with a team developing guidelines for treating COVID-19 patients. The agreement also includes USU's The American Genome Center (TAGC) as well as the HJF administered Austere Environments Consortium for Enhanced Sepsis Outcomes (ACESO).
The agreement expands on the Defense Advanced Research Projects Agency's $150 million research program into a pathogen agnostic extracorporeal blood cleansing medical countermeasure capable of responding to any infectious outbreak by conducting a clinical trial assessing blood purification using ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) and BOA™ Biomedical's GARNET™ device as a treatment for COVID-19.
The agreement is a result of the Defense Health Agency approving U.S. Army Colonel and Chair of the USU Department of Medicine Dr. Kevin Chung's proposed Department of Defense (DoD) COVID RESPONSE Consortium (Rapid Evaluation and Study of the Pandemic Outbreak Nationally by Sustaining and leveraging prolonged field care research Efforts). Chung is the Principal Investigator on this new study.
The Director of ACESO, HJF employee Danielle Clark, PhD, is the Associate Investigator on this new consortium. Together, Chung and Clark will lead clinical evaluation of pathogen agnostic, extracorporeal source control techniques for sepsis along with the manufacturers of the devices, ExThera Medical of California and BOA Biomedical Inc. of Boston.
"ACESO specializes in utilizing biomarkers to anticipate the likelihood of severe infection," Clark said. "We are proud to apply our expertise to support this crucial work across the spectrum of COVID care."
This study builds upon data from Chung's oversight of two patients who received ExThera's Seraph® 100 therapy in April 2020, and more than 175 patients who have been treated under an Food and Drug Administration (FDA) Emergency Use Authorization (EUA) since that time. The agreement expands the trial to research effectiveness and impact. It is designed to take advantage of USU's unique nationwide faculty and campus.
BOA's technology has been proven to capture more than 100 clinically relevant pathogens across bacteria, fungi, parasites, viruses, (including SARS-CoV-2) and toxins. This technology also addresses the growing emergence of antibiotic-resistant bacteria, and thus sepsis, which existing therapies cannot combat.
Seraph® 100 was developed to rapidly and safely remove a broad spectrum of pathogens and sepsis mediators from blood to address the ongoing drug resistance crisis and future pandemics (e.g., COVID-19). It is commercially available under European CE mark and U.S. EUA and has been successfully used to treat bacterial, viral and fungal bloodstream infections since 2019.
This project is sponsored by USU; however, the information or content and conclusions do not necessarily represent the official position or policy of, nor should any official endorsement be inferred on the part of, USU, the DoD, or the U.S. Government.