Safety & Effectiveness Evaluation of Seraph 100 in Treatment of Pts With COVID-19 (CP022)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Seraph 100

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Klinikum Aschaffenburg-Alzenau
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukölln
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Extracorporeal therapy with Seraph 100 blood filter	Device: Seraph 100; Bloodfiltration with Seraph 100
No Intervention: Control; patients receive antibiotics only as standard of care

What is the study measuring?

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
All-cause mortality	All-cause mortality	28 days
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
N (%) of patients with treatment emergent adverse events	N (%) of patients with treatment emergent adverse events	Occurrence within the 28 days follow-up period
Laboratory data	Laboratory data (blood test, hematology, chemistry, coagulation, and blood gases)	Daily during ICU stay (up to 28 days)
Vital signs score	Vital signs score	Daily during ICU stay (up to 28 days)
Physical examination score	Physical examination score	Daily during ICU stay (up to 28 days)
Reduction of viral load	Reduction of viral load	During treatment (minimum treatment duration is 5 hours, maximum treatment duration is 24 hours)

Collaborators and Investigators

• Sponsor: ExThera Medical Corporation
• Collaborators: Vivantes Clinic Neukölln
• Investigators: Principal Investigator: Herwig Gerlach, Prof., Vivantes Neukoelln Berlin

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: CP022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.
• IPD Sharing Time Frame: in 9 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes