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

NCT ID: NCT04724434

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

526 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-04

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Positive Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

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

No interventions assigned to this group

Control group

Patients with negative SARS-CoV-2 antibody test

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patient must meet all of the following criteria.

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


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Department of Health and Human Services

FED

Sponsor Role collaborator

Hegau-Bodensee-Klinikum Singen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PD Dr. med. Marc Kollum

Head of Cardiology and Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Kollum, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Hegau-Bodensee-Klinikum Singen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hegau-Bodensee-Klinikum Singen

Singen, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36035510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40094912 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-1020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.