Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19

Study Overview
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Brief Summary
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Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19

Detailed Description
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This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the treatment of patients with confirmed SARS-CoV-2 infection. The clinical investigation will be conducted at 3 centers in Germany and at 2 centers in Spain. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only). Subjects will be followed for 28 days. For viral quantification, study-related serum samples are done immediately before the initial treatment with Seraph 100 starts in the treatment group or immediately after randomization into the control group. Additionally, serum sampling at timepoint 12 hours is applicable for both treatment and control group.

Official Title
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Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Device: Seraph 100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with confirmed SARS-CoV-2 infection Be ≥ 18 years old and ≤90 years old Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point Written or electronic consent of the subjects who are legally competent and have the capacity to give consent Exclusion Criteria: Subject is currently participating in another clinical investigation Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results Have Child-Pugh Class C cirrhosis Have platelet count <30.000/uL Contraindications for heparin sodium for injection Subjects demonstrating any contraindication for this treatment as described in the IFU Subjects with known allergy of polyethylene and copolyester Subjects with hospital-acquired SARS-CoV-2 infections Subject is held in an institution by court or official order Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The primary objective is to demonstrate the safety and effectiveness of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of SARS-CoV-2 infected patients, measured by the reduction of established and suspected prognostic parameters.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Extracorporeal therapy with Seraph 100 blood filter | Device: Seraph 100<br>* Bloodfiltration with Seraph 100<br>|
| No Intervention: Control<br>patients receive antibiotics only as standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Organ failure | Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 48 hours | 48 hours after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Organ Failure | Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 20, with higher scores indicating more dysfunction) | Daily during ICU stay from the start of the initial treatment until day 4 | 
| All-cause mortality | All-cause mortality | 28 days | 
| Organ dysfunction-free days | Organ dysfunction-free days | Daily during ICU stay (up to 28 days) | 
| Intensive Care Unit (ICU) complications | Intensive Care Unit (ICU) complications | Daily during ICU stay (up to 28 days) | 
| Ventilator-free days (VFDs) | Ventilator-free days (VFDs) | Daily during ICU stay (up to 28 days) | 
| Length of stay (LOS) at ICU and hospital ward | Length of stay (LOS) at ICU and hospital ward | During ICU and hospital ward stay (up to 28 days) | 
| Prognosis Factors | Prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2) | From baseline up to 48 hours | 
| Recurrence of sepsis | Recurrence of sepsis | 7 days | 
| Persistence of sepsis | Persistence of sepsis | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19