A Multicenter Evaluation of the Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19

Abstract

OBJECTIVES: The Seraph100 Microbind Affinity Blood Filter (Seraph 100) (ExThera Medical, Martinez, CA) is an extracorporeal therapy that can remove pathogens from blood, including severe acute respiratory syndrome coronavirus 2. The aim of this study was to evaluate safety and efficacy of Seraph 100 treatment for COVID-19. DESIGN: Retrospective cohort study. SETTING: Nine participating ICUs. PATIENTS: COVID-19 patients treated with Seraph 100 (n = 53) and control patients matched by study site (n = 53). INTERVENTION: Treatment with Seraph 100. MEASUREMENTS AND MAIN RESULTS: At baseline, there were no differences between the groups in terms of sex, race/ethnicity, body mass index, and need for mechanical ventilation. However, patients in the Seraph 100 group were younger (median age, 54 yr; interquartile range [IQR], 41–65) compared with controls (median age, 64 yr; IQR, 56–69; p = 0.009). Charlson comorbidity index scores were lower in the Seraph 100 group (2; IQR, 0–3) compared with the control group (3; IQR, 2–4; p = 0.006). Acute Physiology and Chronic Health Evaluation II scores were also lower in Seraph 100 subjects (12; IQR, 9–17) compared with controls (16; IQR, 12–21; p = 0.011). The Seraph 100 group had higher vasopressor-free days with an incidence rate ratio of 1.30 on univariate analysis. This difference was not significant after adjustment. Seraph 100-treated subjects were less likely to die compared with controls (32.1% vs 64.2%; p = 0.001), a difference that remained significant after adjustment. However, no difference in mortality was observed in a post hoc analysis utilizing an external control group. In the full cohort of 86 treated patients, there were 177 total treatments, in which only three serious adverse events were recorded. CONCLUSIONS: Although this study did not demonstrate consistently significant clinical benefit across all endpoints and comparisons, the findings suggest that broad spectrum, pathogen agnostic, blood purification can be safely deployed to meet new pathogen threats while awaiting targeted therapies and vaccines.

Rationale for sequential extracorporeal therapy (SET) in sepsis

“…The US Department of Defense funded an observational clinical trial to evaluate Seraph-100 efficacy for treating COVID-19 (ClinicalTrials.gov, NCT04606498). Using preliminary data from the first 99 patients (53 treated patients and 46 controls), a nearly fourfold improved survivability odds was observed for Seraph-100-treated patients versus controls [ 40 ]. Data from a COVID-19 registry documenting Seraph-100-treated patients also demonstrated improved survival [ 41 ].…”

Effect of extracorporeal hemoadsorption in critically ill patients with COVID-19: A narrative review

“…On univariate analysis, Seraph 100 treatment was associated with decreased mortality with an odds ratio of 0.26 (95% CI: 0.12-0.59). However, a survival benefit with Seraph 100 treatment compared with the external Penn Medicine cohort was not observed in a post hoc analysis (102).…”

Activated Platelets and Platelet-Derived Extracellular Vesicles Mediate COVID-19-Associated Immunothrombosis

“…Mortality was correlated with late initiation of the treatment as well as with bacterial super-infection ( Schmidt et al, 2022 ). Although the efficacy of this approach has yet to be consistently demonstrated, current data suggest that it can be deployed as an adjunct measure until directed pharmacologic countermeasures are available ( Chitty et al, 2022 ).…”