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

Last updated: December 15, 2021
Sponsor: ExThera Medical Europe BV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04547257
CP022
  • Ages 18-90
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 FailureAssessment score of at least 2 points
  4. At least one additional organ dysfunction assessed by a modified Sequential OrganFailure Assessment score of at least 1 point
  5. Written or electronic consent of the subjects who are legally competent and have thecapacity to give consent

Exclusion

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation
  2. Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period
  3. Presence of comorbid conditions, or other medical, social, or psychological conditionsthat, in the investigator's opinion, could limit the subject's ability to participatein the clinical investigation or to comply with follow-up requirements, or impact thescientific 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 beconsidered voluntary

Study Design

Total Participants: 42
Study Start date:
May 04, 2021
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Vivantes Klinikum Neukölln

    Berlin, 12351
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Carla Kikken-Jussen

    Vaals, Limburg
    Netherlands

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

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