Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19
Organizational Data
- DRKS-ID:
- DRKS00022857
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2020-12-28
- Last update in DRKS:
- 2021-07-30
- Registration type:
- Prospective
Acronym/abbreviation of the study
CP022
URL of the study
Brief summary in lay language
To check the safety and effectiveness of the blood filter in patients with COVID-19.
Brief summary in scientific language
Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the treatment of patients with COVID-19.
Health condition or problem studied
- Free text:
- COVID-19
- Healthy volunteers:
- No Entry
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.
Endpoints
- 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
- 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]
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Spain
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Vivantes Klinikum Berlin Berlin
- University medical center Essen
- Medical center Klinikum Aschaffenburg-Alzenau Aschaffenburg-Alzenau
- Medical center Hospital Vall d'Hebron Barcelona
- Medical center Hospital Clinico San Carlos Madrid
Recruitment period and number of participants
- Planned study start date:
- 2021-01-15
- Actual study start date:
- 2021-05-04
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 42
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 90 Years
- Additional 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 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 11. Subject is held in an institution by court or official order 12. Subject is dependent on the sponsor or investigator so that consent can no longer be considered voluntary
Addresses
Primary Sponsor
- Address:
- ExThera Medical CorporationRobert Ward757 Arnold Drive, Ste BCA 94553 MartinezUnited States
- Telephone:
- 001-510-809-2502
- Fax:
- 001-510-809-2502
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.extheramedical.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Vivantes Klinikum NeukölnProf. Dr. Herwig GerlachRudowerstrasse 4812351 BerlinGermany
- Telephone:
- +4930130142361
- Fax:
- +4930130142497
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vivantes.de
Contact for Public Queries
- Address:
- Vivantes Klinikum NeukölnProf. Dr. Herwig GerlachRudowerstrasse 4812351 BerlinGermany
- Telephone:
- +4930130142361
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Vivantes Klinikum NeukölnProf. Dr. Herwig GerlachRudowerstrasse 4812351 BerlinGermany
- Telephone:
- +4930130142361
- Fax:
- +4930130142497
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vivantes.de
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- ExThera Medical Corporation757 Arnold Drive, Ste BCA 94553 MartinezUnited States
- Telephone:
- 001-510-809-2502
- Fax:
- 001-510-809-2502
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.extheramedical.com
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission des Landes BerlinFehrbelliner Platz 110707 BerlinGermany
- Telephone:
- +49-30-902291220
- Fax:
- +49-30-90283383
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-04-24
- Ethics committee number:
- 00012588
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-12-11
Further identification numbers
- Other primary registry ID:
- NCT04547257 - ClinicalTrials.gov
- EudraCT Number:
- No Entry
- Other secondary IDs:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- To be determined
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry