Background:
The Seraph®100 Microbind Affinity Blood Filter® is a hemofiltration device that is licensed for pathogen reduction in the blood. This includes several viruses. Removal of the nucleocapsid of the SARS-CoV-2 virus by the Seraph®100 has been recently demonstrated. As viral load has repeatedly been shown to correlate with adverse outcome in severe coronavirus disease 2019 (COVID-19), the aim of this registry was to evaluate safety and efficacy of Seraph®100 treatment for COVID-19.
Methods:
An online registry in which main patient charcteristics, treatment coordinates and outcome parameters was documented without reimbursement. So far 12 hospitals in 4 countries on 2 continents took part in the registry. 75 treatment sessions in 60 patients were documented in the registry.
Results:
Adverse effects of the Seraph® 100 treatment were reported in 2 (2.6 %) of the 75 treatments. Eight (10.6 %) of all the procedures ended prematurely due to circuit failure / clotting. Half of the treatments (47.6 %) were performed as hemoperfusion only. 21.6 % of the treatments were performed in conjuction with intermittent hemodialysis. Median treatment time was 4.21 [4.00 - 8.06] h. Anticoagulation was performed using citrate in 20.6 % of treatments. Patients that died despite treatment with the Seraph® 100 filter had a higher rate of bacterial superinfection, higher level of inflammatory laboratory markers (procalcitonin and ferritin) and higher d-dimer levels. While predicted survival rate in ICU patients was >80 %, the observed survival rate was 47.6 %. In non-ICU patients, 4 C score predicted a survival rate of 31.4-34.9 % while the observed survival rate was 22.2 %.
Conclusion:
Seraph® 100 treatment was well tolerated and circuit failure rate was significantly lower than reported for KRT in COVID-19 patients. All patients that died despite of Seraph® 100 treatment had serious pre-existing medical conditions, coexisting bacterial infections and more pronounced systemic signs of inflammation. Compared to the calculated mortality using established scores, the observed mortality in the Seraph® 100 treated patients was lower.
Trial registration:
ClinicalTrials.gov Identifier: NCT04361500