Interim analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry

Abstract

Background The Seraph®100 Microbind Affinity Blood Filter® is a hemoperfusion device that is licensed for the reduction of pathogens, including several viruses, in the blood. It received Emergency Use Authorization (EUA) for the treatment of severe coronavirus disease 2019 (COVID-19) by the FDA. Several studies have shown that the blood viral load of SARS-CoV-2 correlates with adverse outcomes and removal of the nucleocapsid of the SARS-CoV-2 virus by the Seraph®100 has been recently demonstrated. The aim of this registry was to evaluate safety and efficacy of Seraph®100 treatment for COVID-19 patients. Methods Twelve hospitals from six countries representing two continents documented patient and treatment characteristics as well as outcome parameters without reimbursement. Additionally, mortality and safety results of the device were reported. One hundred-and-two treatment sessions in 82 patients were documented in the registry. Four patients were excluded from mortality analysis due to incomplete outcome data, which were available in the other 78 patients. Results Overall, a 30-day mortality rate of 46.2% in the 78 patients with complete follow up was reported. Median treatment time was 5.00 [4.00–13.42] h. and 43.1% of the treatments were performed as hemoperfusion only. Adverse events of the Seraph®100 treatment were reported in 8.8% of the 102 treatments and represented premature end of treatment due to circuit failure. Patients that died were treated later in their ICU stay and onset of COVID symptoms. They also had higher ferritin levels. Multivariate Cox regression revealed that delayed Seraph®100 treatment after ICU admission (>60 hours) as well as bacterial superinfection were associated with mortality. While average predicted mortality rate according to SOFA score in ICU patients was 56.7% the observed mortality was 50.7%. In non-ICU patients 4C-Score average predicted a mortality rate of 38.0% while the observed mortality rate was 11.1% Conclusions The treatment of COVID-19 patients with Seraph®100 is well tolerated and the circuit failure rate was lower than previously reported for KRT in COVID-19 patients. Mortality corelated with late initiation of Seraph treatment after ICU admission and bacterial superinfection infection. Compared to predicted mortality according to 4C-Score and SOFA Score, mortality of Seraph®100 treated patients reported in the registry was lower.

Safety and efficacy of the Seraph® 100 Microbind® Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study

“…Therefore, other renal replacement therapy modalities could not be investigated in this study. However, outside of this investigation the device has been used in the setting of prolonged intermittent renal replacement therapy [29], continues kidney replacement therapy [31] and standalone hemoperfusion [32].…”

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

“…Notably, this is in the context of a critically ill patient population and treatments that lasted for a prolonged period of time (median of 13 hr). This low rate of SAEs is consistent with the only other large series of Seraph 100 in patients with COVID 19, which reported nine adverse events over the course of 102 treatments ( 20 ). Most of these events were circuit failure, and none were considered serious.…”

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

“…A recently published interim analysis of a multicenter observational study in 12 hospitals monitoring 102 treatment sessions in 82 patients confirmed that the treatment was well tolerated. 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 ).…”