Seraph-100 Hemoperfusion in SARS-CoV-2-Infected Patients Early in Critical Illness: A Case Series.

There is an urgent need for therapeutic interventions to alter the course of critically ill coronavirus disease 2019 (CO-VID-19) patients. We report our experience with the Seraph-100 Microbind Affinity Blood Filter (Seraph-100) in 4 patients with COVID-19 early in the course of their critical respiratory illnesses. Patients were diagnosed with COVID-19 and were admitted to intensive care with worsening respiratory failure but did not require dialysis or vasopressors. Patients had to have a PaO2 to FiO2 (P/F ratio) <150 to qualify for hemoperfusion therapy. All patients received standard medical therapy including oral vitamins C and D and zinc in addition to intravenous dexamethasone and remdesivir. Patients received a single 5- to 7-h session with Seraph-100 on a conventional dialysis machine (Fresenius 2008T) via a nontunneled central venous dialysis catheter with a goal of processing at least 100 L of blood. Patients received weight-based subcutaneous enoxaparin anticoagulation, as well as systemic intravenous heparin (70 units/kg), just prior to hemofiltration. Treatment with Seraph-100 hemoperfusion was well tolerated, and all patients were able to finish their prescribed therapy. All patients treated with Seraph-100 survived to be discharged from the hospital. Well-designed clinical trials are needed to determine the overall safety and efficacy of the Seraph-100 Microbind Affinity Blood Filter in COVID-19 patients.

Two Patients With Severe COVID Pneumonia Treated With the Seraph-100 Microbind Affinity Blood Filter.

We present 2 patients with rapidly escalating oxygen requirements from severe acute respiratory syndrome coronavirus 2 infection (COVID-19) treated with the Seraph100 Microbind Affinity Blood Filter under Emergency Use Authorization from the US Federal Drug Administration. The Seraph100 is an extracorporeal hemoperfusion filter previously demonstrated to remove viral particles and pro-inflammatory cytokines from the blood. Treatment with the Seraph100 filter was associated with a rapid improvement in oxygenation and both patients were discharged from the hospital without supplemental oxygen.

The Seraph®-100 Microbind Affinity Blood Filter Does Not Affect Vancomycin, Tacrolimus, and Mycophenolic Acid Plasma Concentrations.

Extracorporeal blood purification is considered an adjunct therapy in critically ill patients with life-threatening conditions such as sepsis and septic shock. It consists of cytokine removal, removal of endotoxins, a combination of both, or the removal of pathogens themselves. The latter technique was introduced for clinical application very recently. This case study describes a case of a 69-year-old female lung transplant recipient patient with a persistent VV-ECMO-related septic deep vein thrombosis with continuous renal replacement therapy-dependent acute kidney injury initiated on the Seraph®-100 Microbind Affinity Filter in order to control the persistent bacteraemia with coagulase-negative staphylococci. Drug plasma concentrations (vancomycin, tacrolimus, and mycophenolic acid) were measured before and after the device to calculate absorber-related drug clearance.

Hemoperfusion with high-affinity polyethylene microbeads (Seraph-100®) for the removal of pathogens in chronic critically ill patients: Clinical experience.

Critically ill septic patients present variable clinical trajectories, with some succumbing to hyperinflammatory responses while others develop a chronic critical illness, characterized by a prolonged low-grade inflammation, muscle atrophy, and mechanical ventilation dependency and often develop secondary infections often caused by from low-virulence microorganisms or reactivated latent viruses. The Seraph-100® hemoperfusion cartridge takes advantage from heparin-coated ultra-high molecular weight polyethylene microbeads mimicking pathogen-binding cell receptors and can adsorb both pathogens and damage-associated molecular patterns released by injured tissues. We describe two chronic critically ill patients who developed secondary viral bloodstream infections successfully treated with this device.

The Seraph 100® Microbind Affinity Blood Filter Does Not Alter Levels of Circulating or Mucosal Antibodies in Critical COVID-19 Patients.

PURIFY-OBS-1 is an observational study evaluating the safety and efficacy of Seraph 100® Microbind Affinity Blood Filter (Seraph 100) use for COVID-19 patients with respiratory failure admitted to the intensive care unit (ICU). The Seraph 100 is a hemoperfusion device containing heparin-coated beads that can bind to, and reduce levels of, some circulating pathogens and inflammatory molecules. This study evaluated whether treatment with the Seraph 100 affected circulating and mucosal antibody levels in critically ill COVID-19 subjects. SARS-CoV-2 anti-spike and anti-nucleocapsid IgG and IgA levels in serum were evaluated at enrollment and on days 1, 4, 7, and 28 after Seraph 100 application, while anti-spike and nucleocapsid IgG, IgA, and secretory IgA levels in tracheal aspirates were evaluated at enrollment and on days 1, 2, 3, 7, and 28. Serum samples were also collected from the pre- and post-filter lines at 1 and 4 h following Seraph 100 application to evaluate the direct impact of the filter on circulating antibody levels. Treatment with the Seraph 100 did not alter the levels of circulating or mucosal antibodies in critically ill COVID-19 subjects admitted to the ICU.

In Vitro Simulated Hemoperfusion on Seraph®-100 as a Promising Strategy to Counteract Sepsis.

Blood purification represents a treatment option for sepsis, improving inflammation and the hyper-activated immune system. This study investigates the binding efficacy of Seraph®-100 against 108 CFU/mL of Staphylococcus aureus (S. aureus), Pseudomonas aeruginosa (P. aeruginosa), and Escherichia coli (E. coli) during a simulated hemoperfusion treatment. The fluorescence-activated cell sorting (FACS) technique was used to evaluate the bacteria reduction, whereas kinetic analysis and cultures revealed bacterial detection and counting at established time points. At the end of the experiment, the filter was cut at three different levels, obtaining suspensions for cultures and scanning electron microscopy (SEM) analyses. The FACS technique revealed a 78.77% reduction of the total bacterial load at the end of the treatment, with maximum filter sequestration occurring in the first 30 min of the treatment. Non-linear regression analysis of kinetic experiments (T0-240 min) highlighted a lower growth rate of S. aureus than the other two Gram bacteria, demonstrating a greater affinity without influencing a reduction rate of 99% for all three bacteria. The analyses of the suspension aliquots of the filter sections confirmed these data, revealing 1 × 108 CFU/mL, equal to the initial bacterial charge. Furthermore, the filter head adsorbed approximately 50% of bacteria, whereas the remaining amount was equally distributed between the body and the tail, as corroborated by SEM analysis. In conclusion, Seraph®-100 adsorbed 108 CFU/mL of S. aureus, E. coli, and P. aeruginosa during an in vitro simulated hemoperfusion session.

Efficacy of hemoperfusion with Seraph-100 in series with single pass albumin dialysis in acute hepatitis B infection: A case report.

Acute and acute-on-chronic liver failure is a cause of death in patients suffering from viral hepatitis, and many cases need liver transplantation. Infection from hepatitis B virus may range from asymptomatic to severe acute and fulminant hepatitis. In this setting, treatment is mainly supportive as there is no consensus on antiviral therapy based on non-nucleoside reverse transcriptase inhibitors. Single-pass albumin dialysis is a liver-support technique for patients suffering from liver failure, that has shown effectiveness in the removal of both water-soluble and albumin-bound toxins, which accumulate due to impairment of the liver's cleansing function. We report here the case of a 62-year-old male who presented with a severe acute hepatitis B infection, liver failure, and marked hyperbilirubinemia. Treatment with single-pass albumin dialysis combined with a hemoperfusion device was successful in improving clinical, physiological, and laboratory parameters.

Treatment for Severe Coronavirus Disease 2019 With the Seraph-100 Microbind Affinity Blood Filter.

To determine whether Seraph-100 (Exthera Medical Corporation, Martinez, CA) treatment provides clinical benefit for severe coronavirus disease 2019 cases that require mechanical ventilation and vasopressor support. DATA SOURCES: The first two patients in the United States treated with the novel Seraph-100 device. These cases were reviewed by the Food and Drug Administration prior to granting an emergency use authorization for treatment of coronavirus disease 2019. STUDY SELECTION: Case series. DATA EXTRACTION: Vasopressor dose, mean arterial pressure, temperature, interleukin-6, C-reactive protein, and other biomarker levels were documented both before and after Seraph-100 treatments. DATA SYNTHESIS: Vasopressor dose, temperature, interleukin-6, and C-reactive protein levels declined after Seraph-100 treatments. Severe acute respiratory syndrome coronavirus 2 viremia was confirmed in the one patient tested and cleared by the completion of treatments. CONCLUSIONS: Seraph-100 use may improve hemodynamic stability in coronavirus disease 2019 cases requiring mechanical ventilation and vasopressor support. These findings warrant future study of a larger cohort with the addition of mortality and total hospital day outcomes.