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Interim analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry
Julius J Schmidt1, Dan Nicolae Borchina2, Mariet Van't Klooster3
1Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany.
Insights
The Seraph® 100 blood filter is safe for COVID-19 patients, with lower mortality rates observed compared to predicted scores. Delayed treatment and bacterial infections were linked to higher mortality risks.
Area of Science:
- Medical Devices
- Infectious Diseases
- Critical Care Medicine
Background:
- The Seraph® 100 Microbind® Affinity Blood Filter is an FDA-authorized hemoperfusion device for pathogen reduction, including viruses.
- It has shown potential in reducing SARS-CoV-2 nucleocapsid levels, a marker correlated with adverse outcomes in severe COVID-19.
- This registry aimed to assess the safety and efficacy of Seraph® 100 in treating COVID-19 patients.
Purpose of the Study:
- To evaluate the safety and efficacy of the Seraph® 100 device in COVID-19 patients.
- To analyze factors associated with mortality in patients treated with the Seraph® 100 filter.
- To compare observed mortality rates with predicted mortality scores.
Main Methods:
- A registry study involving 12 hospitals across six countries documented 102 treatment sessions in 82 COVID-19 patients.
- Data collected included patient characteristics, treatment details, and outcome parameters, with mortality and safety results reported.
- Mortality analysis was performed on 78 patients with complete follow-up data.
Main Results:
- The 30-day mortality rate was 46.2% in patients with complete follow-up.
- Adverse events were reported in 8.8% of treatments, primarily due to circuit failure.
- Delayed Seraph® 100 treatment (>60 hours post-ICU admission) and bacterial superinfection were significantly associated with mortality.
Conclusions:
- Seraph® 100 treatment is well-tolerated in COVID-19 patients, with a low circuit failure rate compared to kidney replacement therapy.
- Observed mortality rates in Seraph® 100-treated patients were lower than predicted by SOFA and 4C scores.
- Timely initiation of treatment and management of bacterial superinfections are crucial for improving outcomes.
Background:
The Seraph® 100 Microbind® Affinity Blood Filter is a haemoperfusion device that is licensed for the reduction of pathogens, including several viruses, in the blood. It received Emergency Use Authorization for the treatment of severe coronavirus disease 2019 (COVID-19) by the Food and Drug Administration (FDA). Several studies have shown that the blood viral load of severe acute respiratory syndrome coronavirus 2 (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 the 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. A total of 102 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. The median treatment time was 5.00 h (4.00-13.42) and 43.1% of the treatments were performed as haemoperfusion only. Adverse events of the Seraph® 100 treatment were reported in 8.8% of the 102 treatments and represented the premature end of treatment due to circuit failure. Patients who died were treated later in their intensive care unit (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 h), as well as bacterial superinfection, were associated with mortality. While average predicted mortality rate according to Sequential Organ Failure Assessment (SOFA) score in ICU patients was 56.7%, the observed mortality was 50.7%. In non-ICU patients, Coronavirus Clinical Characterisation Consortium (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 kidney replacement therapy (KRT) in COVID-19 patients. Mortality correlated with late initiation of Seraph treatment after ICU admission and bacterial superinfection. Compared with predicted mortality according to 4C and SOFA scores, mortality of Seraph® 100-treated patients reported in the registry was lower.
