Clinical trial NCT04724434: Follow-up Study of COVID-19 Patients in the District Konstanz
Official title: Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Hegau-Bodensee-Klinikum Singen
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2021-01-26
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Hospitalization
timeFrame: Between 1 year after enrollment and 5 years after last patient in
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: Between 1 year after enrollment and 5 years after last patient in
measure: KCCQ-12
timeFrame: Between 1 year after enrollment and 5 years after last patient in
Other outcomes:
Locations:
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum Singen
state: Baden-Württemberg
Study officials:
affiliation: Hegau-Bodensee-Klinikum Singen
name: Marc Kollum, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.