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

SARS-CoV-2 Positive Patients Clinical Trial

— FSC19-KN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04724434
• Other study ID #: 20-1020
• Status: Active, not recruiting
• Start date: December 4, 2020
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Hegau-Bodensee-Klinikum Singen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 526
• Est. completion date: July 2026
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Positive Patients

Locations

Country	Name	City	State
Germany	Hegau-Bodensee-Klinikum Singen	Singen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Hegau-Bodensee-Klinikum Singen	Department of Health and Human Services

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Hospitalization	Primary endpoint	Between 1 year after enrollment and 5 years after last patient in
Secondary	EQ-5D-5L	Secondary endpoint	Between 1 year after enrollment and 5 years after last patient in
Secondary	KCCQ-12	Secondary endpoint	Between 1 year after enrollment and 5 years after last patient in