MARTINEZ, Calif.– Physicians across the country are using ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) under emergency use authorization from the U.S. Food and Drug Administration to treat critically ill COVID patients resulting in statistically significant improvements in survival rate among patients whose blood was filtered with the Seraph 100.
The first multicenter randomized controlled trial of the Seraph 100, which has successfully treated hundreds of COVID patients, will be studying the treatment’s ability to reduce ICU length of stay, hospital duration and mortality in patients suffering from septic shock..
“The initial findings in our observational study for COVID patients have been very promising. This feasibility study will get us another step closer to help assess whether or not this therapy has a role in the care of all septic patients, not just COVID,” said Col. Kevin K. Chung, MD, a leading critical care physician and PURIFY investigator.
The study will evaluate the safety and efficacy of pathogen-removing extracorporeal blood purification therapy in critically ill patients with pathogen-associated shock utilizing ExThera’s Seraph 100 filter. This trial is sponsored by the Henry M. Jackson Foundation for the Advancement of Military Medicine and is in collaboration with the Uniformed Services University (USU) of the Health Sciences. Interventional multicenter randomized controlled trials are rare in extracorporeal therapies and require robust signals of efficacy improvement as demonstrated in this case by the PURIFY OBS study.
“ExThera is proud to be saving lives during the COVID-19 pandemic under our FDA Emergency Use Authorization,” said ExThera Medical CEO Robert Ward. “We are confident this new trial will further the expansion of Seraph 100 use in the United States, not only in the treatment of COVID-19 patients but also in deadly sepsis caused by other viral, bacterial and fungal bloodstream infections.”
Enrollment is slated to begin this Fall.
“The more we are able to study the Seraph 100 in a clinical setting will only help us reach more patients fighting COVID-19, which continues to be a concern across the United States,” said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, MD.
The study’s primary outcome measures include the following:
- Efficacy: ICU-free days in the first 28 days
- Alive and not in the ICU (for at least a full 24 hours) in the first 28 days from the time of randomization
- Safety: Adverse Events
- SAEs and >/= grade 3 AEs per CTCAE v5 evaluated from enrollment until the end of hospitalization
The study’s secondary outcome measures include the following: mortality evaluated in-hospital at 28 days; ventilator free days in the first 28 days; vasopressor-free days in the first 28 days; kidney replacement therapy-free days in the first 28 days; hospital stay duration; and survival, 90 days after enrollment.
As this study will also serve as the investigational device exemption (IDE) research needed for Seraph 100’s FDA clearance, the first 10 patients enrolled will study additional parameters demonstrating avoidance of antibiotic adsorption as has been demonstrated in the past.
