NCT04615026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

November 3, 2020

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of thrombosis

    20 minutes

Secondary Outcomes (2)

  • correlation to immunity

    20 minutes

  • Assessment of late complications

    20 minutes

Study Arms (1)

COVID 19 patients

all patients with positive SARS-CoV 2 swap

Diagnostic Test: duplex sonography

Interventions

duplex sonographyDIAGNOSTIC_TEST

all patients with consent receive a duplex ultrasound, blood test, cognitive test and test of smelling

Also known as: test of smell, cognitive test, blood sample
COVID 19 patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all SARS CoV 2 positive patients registered at local health departments (Augsburg) are invited to join the study

You may qualify if:

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

You may not qualify if:

  • under 18 years old no consent anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg

Augsburg, 86165, Germany

Location

Related Publications (1)

  • Schmidbauer L, Kirchberger I, Gosslau Y, Warm TD, Hyhlik-Durr A, Linseisen J, Meisinger C. The association between the number of symptoms and the severity of Post-COVID-Fatigue after SARS-CoV-2 infection treated in an outpatient setting. J Neurol. 2023 Jul;270(7):3294-3302. doi: 10.1007/s00415-023-11752-9. Epub 2023 May 23.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aliquots for proteomics analysis

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alexander Hyhlik-Duerr, MD

    University Hospital Augsburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

November 4, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations