Prevalence of Thrombosis in COVID-Patients

Prevalence of Thrombosis in COVID-Patients in Correlation to Humoral and Cellular Immunity

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: duplex sonography

• Study Type: Observational
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86165
    • University Hospital Augsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• under 18 years old no consent anemia

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of thrombosis	20 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
correlation to immunity	20 minutes
Assessment of late complications	20 minutes

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Alexander Hyhlik-Duerr, MD, University Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: COVID Thrombose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: data as pseudonyms

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No