Vall d'Hebron Barcelona Hospital Campus has been the first center in Europe to include patients in a clinical trial that will test the efficacy of a new blood filter for the treatment of COVID-19. The hospital will also take part of a clinical trial to test this filter on sepsis patients. This system, known as Seraph 100, is able to bind to microorganisms in the blood and reduce the amount of viruses or bacteria that are present. It will now be studied its ability to improve the clinical evolution of patients who have the infection. This technology has been developed by ExThera Medical and was tested by the Defense Advanced Research Projects Agency (DARPA) of the United States Department of Defense. It will now be validated in Spain, among other countries, at the Vall d'Hebron Barcelona Hospital Campus and the Hospital Clínico San Carlos de Madrid, together with the Cardiolink company.
The system is based on the fact that, sometimes, the severity of infections is associated with the amount of pathogens that exist in the blood, since it involves a very strong systemic immune response. “It has already been proven that Seraph 100 is capable of reducing the viral load in the blood. Now, in the case of COVID-19, we want to study whether eliminating SARS-CoV-2 from the blood is enough to reduce the severity of patients", explains Dr. Ricard Ferrer, head of the Hospital's Intensive Medicine Service Vall d'Hebron University and head of the Shock, Organic Dysfunction and Resuscitation Research Group (SODIR) of the Vall d'Hebron Research Institute (VHIR). Studies carried out so far have shown that in certain cases this system can improve lung function and oxygen saturation in critically ill COVID-19 patients.
When a pathogen infects the body, it often needs to bind to a molecule called heparan sulfate that is found on the surface of cells. The Seraph 100 filter consists of a set of small particles formed by a material similar to this heparan sulfate in cells. Thus, it has been shown that many types of pathogens, among which is SARS-CoV-2, can bind to the filter as they bind to cells. This technology works in a similar way to a haemodialysis system, filtering the blood, with the aim that the microorganisms bind to the filter and are eliminated from the bloodstream. A session of about 4-6 hours would be enough to clean a large part of the pathogens found in the blood.
In addition to testing Seraph 100 in COVID-19 patients, a second trial will look at its effectiveness in killing bacteria in the blood in cases of sepsis. In these cases, broad-spectrum antibiotics are also administered. “We hope to be able to treat sepsis before we know which specific pathogen is causing the infection, and therefore, before we know which is the optic antibiotic”, comments Dr. Ferrer, who further adds that “Seraph 100 would allow us to offer a treatment for infections by bacteria resistant to the most common antibiotics, since the filter is completely nonspecific”.
Seraph 100, like other types of filters that have been used for years in Intensive Care Units, is not only capable of binding microorganisms but also mediators of inflammation. For example, it is capable of eliminating molecules involved in the cytokine storm that is related to the severity of infections.
Until now, no side effects associated with the use of this system have been observed, so the researchers consider that it could be a novel treatment opportunity for all those critical patients due to infections of different types. As ExThera Medical assures, safety profile is consistent with standard extracorporeal labelling. However, contrary to other extracorporeal treatments, improvements in hemodynamic stability are often observed due to Seraph 100’s unique mechanism.
About Seraph 100
Seraph 100 is a technology that has been developed by ExThera Medical and was tested by the Defense Advanced Research Projects Agency (DARPA) of the Department of Defense of the United States. It was already tested in 300 patients with COVID-19 in the USA. In Europe, it was approved by pathogens removal, including SARS-CoV-2 and has been available since 2019 and tested with some infections with positive outcomes.
Two clinical trials, sponsored by ExThera Medical, are now ongoing to verify the impact of the use of this system on the evolution of patients with COVID-19 and sepsis, where the Vall d'Hebron Barcelona Hospital Campus and the Hospital Clínico San Carlos de Madrid participate, together with the Cardiolink company in Spain. In relation to the study with COVID-19, 42 patients from Spain and Germany will participate. In the case of sepsis, 232 patients in 25 hospitals in 9 EU member states will be recruited for the Post Market Study to analyse the reduction of the pathogen load in septic patients.