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

Completed

• Conditions: SARS-CoV-2 Positive Patients

• Registration Number: NCT04724434
• Lead Sponsor: Hegau-Bodensee-Klinikum Singen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-04
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-26
• Primary Completion: 2021-07-17
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 526

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Hospitalization	Between 1 year after enrollment and 5 years after last patient in	Primary endpoint

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hegau-Bodensee-Klinikum Singen; 🇩🇪 Singen, Baden-Württemberg, Germany