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

NCT04547257 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP022
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Organ Failure

  Daily during ICU stay from the start of the initial treatment until day 4

• All-cause mortality

  28 days

• Organ dysfunction-free days

  Daily during ICU stay (up to 28 days)

• Intensive Care Unit (ICU) complications

  Daily during ICU stay (up to 28 days)

• Ventilator-free days (VFDs)

  Daily during ICU stay (up to 28 days)

Other Outcomes (5)

• N (%) of patients with treatment emergent adverse events

  Occurrence within the 28 days follow-up period

• Laboratory data

  Daily during ICU stay (up to 28 days)

• Vital signs score

  Daily during ICU stay (up to 28 days)

Study Arms (2)

Treatment

EXPERIMENTAL

Extracorporeal therapy with Seraph 100 blood filter

Device: Seraph 100

Control

NO INTERVENTION

patients receive antibiotics only as standard of care

Interventions

Seraph 100 DEVICE

Bloodfiltration with Seraph 100

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ExThera Medical Corporation: lead
• Vivantes Clinic Neukölln: collaborator

Study Sites (5)

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, 63739, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Herwig Gerlach, Prof.

  Vivantes Neukoelln Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: September 14, 2020
• Study Start: May 4, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: in 9 months

Locations

ES (2); DE (3)