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

Not Applicable

• Conditions: COVID-19
• Interventions: Device: Seraph 100

• Registration Number: NCT04547257
• Lead Sponsor: ExThera Medical Europe BV

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Status Verified: 2021-04
• Study Start: 2021-05-04
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Subjects with confirmed SARS-CoV-2 infection
2. Be ≥ 18 years old and ≤90 years old
3. Acute respiratory distress syndrome assessed by a modified Sequential Organ Failure Assessment score of at least 2 points
4. At least one additional organ dysfunction assessed by a modified Sequential Organ Failure Assessment score of at least 1 point
5. Written or electronic consent of the subjects who are legally competent and have the capacity to give consent

Exclusion Criteria

1. Subject is currently participating in another clinical investigation
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
3. 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
4. Have Child-Pugh Class C cirrhosis
5. Have platelet count <30.000/uL
6. Contraindications for heparin sodium for injection
7. Subjects demonstrating any contraindication for this treatment as described in the IFU
8. Subjects with known allergy of polyethylene and copolyester
9. Subjects with hospital-acquired SARS-CoV-2 infections
10. Subject is held in an institution by court or official order
11. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Seraph 100	Extracorporeal therapy with Seraph 100 blood filter

Primary Outcome Measures

Name	Time	Method
Change in Organ failure	48 hours after initial treatment	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Klinikum Aschaffenburg-Alzenau; 🇩🇪 Aschaffenburg, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain