Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00022857
Date of Registration in DRKS: 2020/12/28
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 00012588, Ethik-Kommission des Landes Berlin

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Secondary IDs

EUDAMED-No. (for studies acc. to Medical Devices act): CIV-20-04-032765

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Health Condition or Problem studied

Free text: COVID-19

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Interventions/Observational Groups

Arm 1: The treatment group will have the bloodfiltration with the Seraph 100 plus antibiotics.
Arm 2: Control Group only receive antibiotics therapy.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Treatment
Assignment: Other
Phase: IIb
Off-label Drug use: 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

DE: Germany
ES: Spain

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Locations of Recruitment

Medical Center Vivantes Klinikum Berlin, Berlin
University Medical Center Essen
Medical Center Klinikum Aschaffenburg-Alzenau, Aschaffenburg-Alzenau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2021/03/15
Target Sample Size: 42
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- ExThera Medical Corporation
- Mr. Robert Ward
- 757 Arnold Drive, Ste B
- CA 94553 Martinez
- United States
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- Telephone: 001-510-809-2502
- Fax: 001-510-809-2502
- E-mail: robert at extheramedical.com
- URL: http://www.extheramedical.com
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Contact for Scientific Queries
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- Vivantes Klinikum Neuköln
- Mr. Prof. Dr. Herwig Gerlach
- Rudowerstrasse 48
- 12351 Berlin
- Germany
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- Telephone: +4930130142361
- Fax: +4930130142497
- E-mail: herwig.gerlach at vivantes.de
- URL: http://www.vivantes.de
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Contact for Public Queries
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- Vivantes Klinikum Neuköln
- Mr. Prof. Dr. Herwig Gerlach
- Rudowerstrasse 48
- 12351 Berlin
- Germany
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- Telephone: +4930130142361
- Fax: [---]*
- E-mail: herwig.gerlach at vivantes.de
- URL: [---]*
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Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)
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- ExThera Medical Corporation
- Mr. Robert Ward
- 757 Arnold Drive, Ste B
- CA 94553 Martinez
- United States
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- Telephone: 001-510-809-2502
- Fax: 001-510-809-2502
- E-mail: robert at extheramedical.com
- URL: http://www.extheramedical.com
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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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.