Follow-up Study of COVID-19 Patients in the District Konstanz

NCT04724434 | Completed DMC

• 1 other identifier: 20-1020
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2 Positive Patients

Keywords

COVID-19 Virus disease; SARS-CoV-2; Hospitalization; Quality of life; EQ-5D-5L; Cardiomyopathy, Kansas City (KCCQ-12)

Outcome Measures

Primary Outcomes (1)

• Rate of Hospitalization

  Primary endpoint

  Between 1 year after enrollment and 5 years after last patient in

Secondary Outcomes (2)

• EQ-5D-5L

  Between 1 year after enrollment and 5 years after last patient in

• KCCQ-12

  Between 1 year after enrollment and 5 years after last patient in

Study Arms (2)

Study group

Patients with positive test for SARS-CoV-2 by PCR

Control group

Patients with negative SARS-CoV-2 antibody test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient must meet all of the following criteria.
• Positive test for SARS-CoV-2 by PCR
• Signed informed consent and privacy policy
• Volunteer must meet all of the following criteria.
• No contact to SARS-CoV-2 positive patients
• negative SARS-CoV-2 antibody test
• Signed informed consent and privacy policy

You may not qualify if:

• Patient/Volunteer will be excluded if any of the following conditions apply:
• Patient/Volunteer age \< 18 years
• Patient/Volunteer who are unable to read the information and understand the nature of the study
• Patient/Volunteer participate in any other clinical study

Sponsors & Collaborators

• Hegau-Bodensee-Klinikum Singen: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Hegau-Bodensee-Klinikum Singen

Singen, Baden-Wurttemberg, 78224, Germany

Location

Related Publications (2)

• Haberland E, Haberland J, Richter S, Schmid M, Hromek J, Zimmermann H, Geng S, Winterer H, Schneider S, Kollum M. Seven Months after Mild COVID-19: A Single-Centre Controlled Follow-Up Study in the District of Constance (FSC19-KN). Int J Clin Pract. 2022 Aug 12;2022:8373697. doi: 10.1155/2022/8373697. eCollection 2022.

  PMID: 36035510 BACKGROUND

• Kohler AK, Richter S, Schmid M, Zimmermann H, Winterer H, Schneider S, Kollum M. Three-Year Follow-Up of COVID-19 Cases in District of Constance, Germany. A Prospective, Controlled Cohort Study (FSC19-KN). J Clin Med. 2025 Feb 21;14(5):1439. doi: 10.3390/jcm14051439.

  PMID: 40094912 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

In the Control group a SARS-CoV-2 antibody test will be performed.

MeSH Terms

Conditions

COVID-19; Cardiomyopathies

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Marc Kollum, PD Dr. med.

  Hegau-Bodensee-Klinikum Singen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology and Internal Medicine

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 26, 2021
• Study Start: December 4, 2020
• Primary Completion: July 17, 2021
• Study Completion: December 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

DE (1)