Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)

March 10, 2025 updated by: PD Dr. med. Marc Kollum, Hegau-Bodensee-Klinikum Singen

Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)

This is a prospective single-center study for the follow-up of SARS-CoV-2 positive patients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patients with SARS-CoV-2 infection are currently being treated in the clinics of the LKN's health network at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations. So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part of this study, the disease progression of these patients will be monitored. Study objective: Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regarding their secondary diseases and quality of life.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Singen, Baden-Württemberg, Germany, 78224
        • Hegau-Bodensee-Klinikum Singen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The SARS-CoV-2 positive patients in the Konstanz district are invited to participate in the study by information letter. The addressing and sending of the study documents will take place via the Health Department of the district of Konstanz. The study team only gets knowledge of those positively tested patients who responded to the cover letter and declare their informed consent to the study.

Probands for the control group will be contacted and invited to the study by announcements in local newspapers and flyers in our hospital. Only those probands are included to the study, who can be matched to one participant of the SARS-CoV-2 positive group by age, gender and cardiovascular risk factors such as smoking, diabetes mellitus and arterial hypertension.

Description

Inclusion Criteria:

A Inclusion Criteria of SARS-CoV-2 positive patients:

Patient must meet all of the following criteria.

  1. Positive test for SARS-CoV-2 by PCR
  2. Signed informed consent and privacy policy

B Inclusion Criteria of the control Group:

Volunteer must meet all of the following criteria.

  1. No contact to SARS-CoV-2 positive patients
  2. negative SARS-CoV-2 antibody test
  3. Signed informed consent and privacy policy

Exclusion Criteria:

Patient/Volunteer will be excluded if any of the following conditions apply:

  1. Patient/Volunteer age < 18 years
  2. Patient/Volunteer who are unable to read the information and understand the nature of the study
  3. Patient/Volunteer participate in any other clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
Patients with positive test for SARS-CoV-2 by PCR
Control group
Patients with negative SARS-CoV-2 antibody test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Hospitalization
Time Frame: Between 1 year after enrollment and 5 years after last patient in
Primary endpoint
Between 1 year after enrollment and 5 years after last patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D-5L
Time Frame: Between 1 year after enrollment and 5 years after last patient in
Secondary endpoint
Between 1 year after enrollment and 5 years after last patient in
KCCQ-12
Time Frame: Between 1 year after enrollment and 5 years after last patient in
Secondary endpoint
Between 1 year after enrollment and 5 years after last patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hegau-Bodensee-Klinikum Singen

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Marc Kollum, PD Dr. med., Hegau-Bodensee-Klinikum Singen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

July 17, 2021

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 23, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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