Clinical Trials

Learn More About Seraph 100 in Use

PURIFY Program

Initiated at Uniformed Services University of the Health Sciences (USUHS), the program is an off-shoot of the DARPA dialysis-like therapy (DLT) program aimed at developing and/or evaluating adjunctive therapies in a pandemic setting when no proven therapies are available. Seraph 100 is being tested in the ongoing PURIFY Program.

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US IDE Multicenter Prospective Randomized Controlled Trial: PURIFY-RCT

Multi-center, randomized controlled trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock. Patients will be randomized to receive either Arm 1: Seraph 100 treatment plus ‘State of the Art’ or Arm 2: ‘State of the Art’ care alone. “State of the Art care” will be defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock.

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Multi-center, observational 3-arm cohort study composed of subjects with informed consent (1) treated with Seraph 100 after the date of the EUA approval (retrospective), (2) additional eligible admitted patients also meeting inclusion/exclusion criteria (prospective), and (3) Historical matched control group composed of admitted patients at participating sites with severe COVID-19 infection, meeting EUA treatment criteria, but not treated with Seraph 100 (matched control).

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European COVID-19 Registry

Registry of COVID-19 patients treated with the Seraph 100 Microbind Affinity Blood Filter (COSA) with the purpose to investigate the effectiveness and safety of the Seraph 100 in the treatment of COVID-19 patients.

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European Post Market Study

Safety and performance evaluation of Seraph 100 in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection. 21 clinical sites in 8 countries are participating in this study including major teaching hospitals and medical centers in Austria, Belgium, France, Germany, Italy, the Netherlands, Poland, and the United Kingdom.

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Seraph 100 CE Mark Clinical Trial (completed)

ExThera Medical completed a multi-center, non-randomized European trial for Seraph 100 in 2019. The study enrolled patients at four centers in Germany. 

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