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Prevalence of Thrombosis in COVID-Patients

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: NCT04615026
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Alexander Hyhlik-Dürr, University Hospital Augsburg

Study Description
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Brief Summary:
Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.

Condition or disease Intervention/treatment
Covid19 Diagnostic Test: duplex sonography

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Prevalence of Thrombosis in COVID-Patients in Correlation to Humoral and Cellular Immunity
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
COVID 19 patients
all patients with positive SARS-CoV 2 swap
 Diagnostic Test: duplex sonography
all patients with consent receive a duplex ultrasound, blood test, cognitive test and test of smelling
Other Names:
  • test of smell
  • cognitive test
  • blood sample


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of thrombosis [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. correlation to immunity [ Time Frame: 20 minutes ]
  2. Assessment of late complications [ Time Frame: 20 minutes ]

Biospecimen Retention:   Samples Without DNA
Aliquots for proteomics analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all SARS CoV 2 positive patients registered at local health departments (Augsburg) are invited to join the study
Criteria

Inclusion Criteria:

  • SARS CoV 2 positive swap, at least 4 weeks after infection

Exclusion Criteria:

  • under 18 years old no consent anemia
Contacts and Locations
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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): NCT04615026


Contacts
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Contact: Yvonne Gosslau, MD +49821400161977 Yvonne.gosslau@uk-augsburg.de
Contact: Alexander Hyhlik-Duerr, MD +498214002655 alexander.hyhlik-duerr@uk-augsburg.de

Locations
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Germany
University Hospital Augsburg Recruiting
Augsburg, Germany, 86165
Contact: Yvonne Gosslau, MD    +49821400161977    Yvonne.gosslau@uk-augsburg.de   
Contact: Alexander Hyhlik-Duerr, MD    +498214002655    alexander.hyhlik-duerr@uk-augsburg.de   
Sponsors and Collaborators
University Hospital Augsburg
Investigators
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Principal Investigator: Alexander Hyhlik-Duerr, MD University Hospital Augsburg
More Information
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Responsible Party: Alexander Hyhlik-Dürr, Head of department, University Hospital Augsburg
ClinicalTrials.gov Identifier: NCT04615026    
Other Study ID Numbers: COVID Thrombose
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data as pseudonyms

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases