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

Abstract

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.

SciScore for 10.1101/2021.04.20.21255810: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Ethics	IRB: The Blood purification with Seraph®100 Microbind Affinity Blood Filter® for the treatment of severe COVID-19: An Observational Study (PURIFY-OBS-1) was reviewed and approved by the Advarra institutional review board in accordance with all applicable Federal regulations governing human research protections (Clinicaltirals.gov Identifier NCT04606498).
Sex as a biological variable	not detected.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.

Table 2: Resources

Software and Algorithms
Sentences	Resources
Study personnel entered data into an on-line electronic data capture form in REDCap (Vanderbilt University, Nashville, TN).	REDCap suggested: (REDCap, RRID:SCR_003445)
Data…

SciScore for 10.1101/2021.04.20.21255810: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Ethics	IRB: The Blood purification with Seraph®100 Microbind Affinity Blood Filter® for the treatment of severe COVID-19: An Observational Study (PURIFY-OBS-1) was reviewed and approved by the Advarra institutional review board in accordance with all applicable Federal regulations governing human research protections (Clinicaltirals.gov Identifier NCT04606498).
Sex as a biological variable	not detected.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.

Table 2: Resources

Software and Algorithms
Sentences	Resources
Study personnel entered data into an on-line electronic data capture form in REDCap (Vanderbilt University, Nashville, TN).	REDCap suggested: (REDCap, RRID:SCR_003445)
Data were analyzed using Stata version 16.1 (StataCorp, College Station, TX).	StataCorp suggested: (Stata, RRID:SCR_012763)

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

Although our study demonstrates promising results, limitations exist. Firstly, this is a retrospective analysis and not a randomized controlled trial. Since each study site had slightly different local criteria for initiating therapy with Seraph 100, we were unable to establish standardized criteria for historical control subjects. Each site was asked to apply their clinical practice criteria to patients treated at their institution prior to the availability of the Seraph 100 at their site to select control patients. This introduces the possibility of selection bias in the control group. Secondly, treatment times were not standardized and ranged from 15 minutes to over 2 days. Lastly, while the majority of patients in both groups were treated with remdesivir and glucocorticoids, these treatments were not standardized and data on other treatments (such as convalescent plasma, baricitinib, and tocilizumab) were not recorded.

Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

Identifier	Status	Title
NCT04606498	Recruiting	Blood Purification With Seraph 100 Microbind Affinity Blood …

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

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