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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04724434

Acronym

FSC19-KN

Enrollment

526

Registered

2021-01-26

Start date

2020-12-04

Completion date

2024-12-31

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results