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Safety & Performance Evaluation of Seraph 100 in Treatment of Pts With COVID-19 (CP022)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547257
Recruitment Status : Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
ExThera Medical Corporation
Information provided by (Responsible Party):
ExThera Medical Europe BV

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

Condition or disease Intervention/treatment Phase
COVID-19 Device: Seraph 100 Not Applicable

Detailed Description:

This is a prospective, open-label, randomized, controlled clinical investigation designed to evaluate the safety and performance of Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection (BSI).

Subjects from treatment and control group will follow standard of care treatment. Control group will not be treated with Exthera Medical Seraph 100 Affinity Blood Filter (Seraph 100).

The clinical investigation will be conducted at approximately 3 centers in Germany. Subjects will be randomized to the treatment group (Seraph 100 + standard of care) versus control group (standard of care only).

Subjects will be followed until the last subject completes their 28-day follow-up phone call. Clinical Investigation follow-up will occur at Baseline (confirmation of eligibility), Day 0 or Treatment, Follow-up visits after 12 hours, at Day 1, after 36 hours, at Day 2, Day 3, Day 7 and Follow-up phone call at 28 days

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The primary objectives are to demonstrate the safety and performance of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the clinical improvement of COVID-19 patient, measured by the reduction of established and suspected prognostic parameters
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of Seraph 100 Filter in the Treatment of Patients With COVID-19
Estimated Study Start Date : December 15, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : April 15, 2021

Arm Intervention/treatment
Experimental: Treatment
Extracorporal therapy with Seraph 100 blood filter
Device: Seraph 100
Bloodfiltration with Seraph 100

No Intervention: Control
patients receive antibiotics only as standard of care



Primary Outcome Measures :
  1. Change in Organ failure [ Time Frame: upto 48 hours ]
    Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-24 hours, with higher scores indicating more dysfunction) from baseline to 48 hours


Secondary Outcome Measures :
  1. Change in Organ Failure [ Time Frame: During ICU stay at 12hours, 24hours, 36hours, 96hours after treatment ]
    Change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range 0 - 24 hours, with higher scores indicating more dysfunction

  2. All-cause mortality [ Time Frame: up to 28 days ]
    All-cause mortality

  3. Change in Viral load [ Time Frame: up to 5 hours ]
    Reduction of viral load

  4. Organ dysfunction-free days [ Time Frame: up to 28 days ]
    Organ dysfunction-free days

  5. ICU complications [ Time Frame: Daily during ICU stay up to 28 days ]
    Reduction of Intensive Care Unit (ICU) complications

  6. Ventilator-free days (VFDs [ Time Frame: Daily ICU stay up to 28 days ]
    Ventilator-free days (VFDs

  7. Length of stay (LOS) at ICU [ Time Frame: Daily up to 28 days ]
    Length of stay (LOS) at ICU and hospital ward

  8. Prognosis Factors [ Time Frame: up to 48 hours ]
    Change of prognosis factors (D-Dimere, Troponin T, Ferritin, NTpro-BNP, LDH, IL6, sIL2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with confirmed COVID-19 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547257


Contacts
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Contact: Carla Kikken-Jussen + 31 43 8200 399 carla@extheramedical.com

Locations
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Netherlands
Carla Kikken-Jussen
Vaals, Limburg, Netherlands
Contact: Carla Kikken-Jussen    +31 43 8200 399    carla@extheramedical.com   
Contact: Natascha de Jong    +31682500427    natascha@extheramedical.com   
Sponsors and Collaborators
ExThera Medical Europe BV
ExThera Medical Corporation
Investigators
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Principal Investigator: Herwig Gerlach, Prof. Vivantes Neukoelln Berlin
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Responsible Party: ExThera Medical Europe BV
ClinicalTrials.gov Identifier: NCT04547257    
Other Study ID Numbers: CP022
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Sponsor will be responsible for determining whether to register the clinical investigation on www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of Medical Journal Editors guidelines, or any other applicable guidelines.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: in 9 months
URL: http://extheramedical.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ExThera Medical Europe BV:
COVID-19