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Registry of COVID-19 Patients Treated With the Seraph 100 Microbind Affinity Blood Filter (COSA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361500
Recruitment Status : Unknown
Verified April 2020 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.

Condition or disease Intervention/treatment
COVID-19 Device: Seraph 100

Detailed Description:
During the ongoing COVID-19 pandemic, millions of people have been infected with SARS- Cov-2 worldwide. In the absence of an approved vaccine or medical treatment, there is an emerging need for treatment options, especially in critically ill patients. Multiple pharmacological and non-pharmacological therapies are being investigated. In 2019, the Seraph® 100 Microbind® Affinity Blood Filter (ExThera Medical Corporation, CA, USA) was approved for the removal of pathogens in Europe. On April 17th the FDA granted Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Registry for the Evaluation of Safety and Effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the Therapy of COVID-19 Patients (COSA)
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
COVID-19 patients with Seraph 100 therapy Device: Seraph 100
Seraph 100 therapy during a COVID-19 infection




Primary Outcome Measures :
  1. Survival [ Time Frame: 30 days ]
    Overall Survival after Seraph 100 therapy session


Secondary Outcome Measures :
  1. Length of ICU stay [ Time Frame: 30 days ]
    Time spend in the ICU after Seraph 100 therapy session

  2. Length of Hospital stay [ Time Frame: 30 days ]
    Time spend in the hospital after Seraph 100 therapy session

  3. Length of ventilator therapy [ Time Frame: 30 days ]
    Time spend on ventilator after Seraph 100 therapy session

  4. Adverse events [ Time Frame: 30 days ]
    Report of any Seraph 100 therapy related adverse events



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 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with prooven COVID-19 infection with confirmed or imminent respiratory failure and Treatment with the Seraph® 100 Microbind® Affinity Blood Filter.
Criteria

Inclusion Criteria:

  • COVID-19 infection
  • Treatment with the Seraph® 100 Microbind® Affinity Blood Filter
  • Voluntary consent to participate in Registry

Exclusion Criteria:

- none


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): NCT04361500


Contacts
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Contact: Julius J Schmidt, Dr +495115326319 schmidt.julius@mh-hannover.de
Contact: Jan T Kielstein, Prof +495315952380 kielstein@yahoo.com

Locations
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Germany
Academic Teaching Hospital Brunswick Recruiting
Brunswick, Lower Saxony, Germany
Contact: Jan T Kielstein, Prof       kielstein@yahoo.com   
Hannover Medical School Recruiting
Hannover, Germany
Contact: Julius J Schmidt, Dr       schmidt.julius@mh-hannover.de   
Principal Investigator: Julius J Schmidt         
Sub-Investigator: Bernhard MW Schmidt         
Sponsors and Collaborators
Hannover Medical School
Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT04361500    
Other Study ID Numbers: COSA-8998
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases