Trial document




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  DRKS00022857

Trial Description

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Title

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

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Trial Acronym

CP022

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URL of the Trial

http://www.extheramedical.com

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Brief Summary in Lay Language

To check the safety of the Blood filter in patients with COVID-19.

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Brief Summary in Scientific Language

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

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

To be determined

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Organizational Data

  •   DRKS00022857
  •   2020/12/28
  •   [---]*
  •   no
  •   Approved
  •   00012588, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   CIV-20-04-032765 
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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   The treatment group will have the bloodfiltration with the Seraph 100 plus antibiotics.
  •   Control Group only receive antibiotics therapy.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   IIb
  •   N/A
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Primary Outcome

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

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Secondary Outcome

Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 – 20, with higher scores indicating more dysfunction)
Time frame: [During ICU stay at 12h, 24h, 36h, 96h after treatment]

All-cause mortality
Time frame: [28 days]
• Organ dysfunction-free days
Time frame: [Daily during ICU stay]
• Reduction of Intensive Care Unit (ICU) complications
Time frame: [Daily during ICU stay]
• Ventilator-free days (VFDs)
Time frame: [Daily during ICU stay]
• Length of stay (LOS) at ICU and hospital ward
• Reduction of prognosis factors (D-Dimer, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2)
Time frame: [From baseline to 48 hours]

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Countries of Recruitment

  •   Germany
  •   Spain
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2021/03/15
  •   42
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

1. Patients 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

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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 neutropenia (absolute neutrophil count <500 cells/uL)
5. Have Child-Pugh Class C cirrhosis
6. Have platelet count <30.000/uL
7. Contraindications for heparin sodium for injection
8. Subjects demonstrating any contraindication for this treatment as described in the IFU
9. Subjects with known allergy of polyethylene and copolyester
10. Subjects with hospital-acquired SARS-CoV-2 infections

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Addresses

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    • ExThera Medical Corporation
    • Mr.  Robert  Ward 
    • 757 Arnold Drive, Ste B
    • CA 94553  Martinez
    • United States
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    • Vivantes Klinikum Neuköln
    • Mr.  Prof. Dr.  Herwig  Gerlach 
    • Rudowerstrasse 48
    • 12351  Berlin
    • Germany
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    • Vivantes Klinikum Neuköln
    • Mr.  Prof. Dr.  Herwig  Gerlach 
    • Rudowerstrasse 48
    • 12351  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • ExThera Medical Corporation
    • Mr.  Robert  Ward 
    • 757 Arnold Drive, Ste B
    • CA 94553  Martinez
    • United States
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.