MARTINEZ, Calif.—After encouraging preliminary results in the treatment of critically ill COVID-19 patients at a military hospital in the U.S. and fourteen other hospitals in Europe, the U.S. Department of Defense (DOD) has selected ExThera’s Seraph 100 Microbind Affinity Blood Filter (Seraph 100) as one of its main interventions in a pivotal, U.S.-based randomized controlled trial. Financial support for the multi-center trial will be provided by the DOD, and the trial will be run by investigators at the Uniformed Services University in Bethesda, Maryland.
Seraph 100 is the first device approved for the reduction of pathogens in blood. As a patient’s blood flows through the Seraph filter, it passes over tiny beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are captured and adsorbed onto the surface of the beads, and removed from the bloodstream. The blood is returned to the patient with blood cells and proteins intact. Seraph targets the pathogens that cause the infection, while binding and removing harmful substances generated by both the pathogen and the body’s response to the infection.
COVID-19 patients, including those with preexisting medical conditions, have been treated with Seraph 100 after showing serious symptoms of the virus. Initial reports indicate that Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with poor patient outcome: IL-6, Ferritin, D-dimers, LDH, and Nt-proBNP all decreased during Seraph 100 treatments of COVID-19 patients. The device appears to help improve patient outcomes by providing additional time for supportive care while reducing the sources of inflammation. It may also prevent further damage by reducing SARS-CoV-2 virus/RNA in the bloodstream.
“We are excited to have this opportunity and confident that this large DOD clinical trial will firmly establish the safety and efficacy of Seraph 100 as a treatment for COVID-19 treatment,” said Bob Ward, National Academy of Engineering, president and CEO of ExThera. “A successful trial will also support the use of Seraph 100 as a broad-spectrum countermeasure against future pandemics, especially during the critical period before vaccines are available.”
Seraph 100 earned its CE Mark in the third quarter of 2019. It’s widely available in Europe, where it is the subject of a large clinical trial for treatment of a variety of bloodstream infections (BSI). Prior to the COVID-19 pandemic, It was being used to treat individual cases of sepsis and drug-resistant BSIs in the prevention of septic shock. But over the past few months, most clinical cases have involved COVID-19.
In the treatment of bacterial infections, Seraph 100 has quickly reduced drug-resistant bloodstream pathogens and consistently improved patients’ oxygen saturation. The binding of the SARS-CoV-2 virus together with the ability to treat secondary bacterial infections reportedly makes Seraph 100 therapy unique in the treatment of COVID-19.
In contrast to other blood purification technologies, which only remove molecules, Seraph 100 quickly lowers the concentration of viruses, bacteria and fungi in whole blood. In preclinical testing and in clinical use, Seraph 100 has been shown to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens — providing a long-awaited therapy that addresses the severe problem of drug-resistance, and new and future microbial threats like the COVID-19 virus.
The U.S. Food and Drug Administration granted Seraph 100 Emergency Use Authorization (EUA) during the current pandemic. Under the EUA, Seraph 100 is broadly available in the U.S. for COVID-19 treatments.