Follow-up Study of COVID-19 Patients in the District Kons... | NCT04724434

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

NCT04724434

Sponsor

Hegau-Bodensee-Klinikum Singen

Status

Completed

Last Update Posted

Mar 12, 2025Actual

Enrollment

526Actual

Phase

Not provided

Conditions

SARS-CoV-2 Positive Patients

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2020Actual

Primary Completion Date

Jul 17, 2021Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Jan 23, 2021

First Posted Date

Jan 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 12, 2025Actual

Name	Class
Department of Health and Human Services	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

526Actual

Label	Type	Description	Intervention Names
Study group		Patients with positive test for SARS-CoV-2 by PCR
Control group		Patients with negative SARS-CoV-2 antibody test

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A Inclusion Criteria of SARS-CoV-2 positive patients:

Patient must meet all of the following criteria.

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

B Inclusion Criteria of the control Group:

Volunteer must meet all of the following criteria.

No contact to SARS-CoV-2 positive patients
negative SARS-CoV-2 antibody test
Signed informed consent and privacy policy

Exclusion Criteria:

Patient/Volunteer will be excluded if any of the following conditions apply:

Patient/Volunteer age < 18 years
Patient/Volunteer who are unable to read the information and understand the nature of the study
Patient/Volunteer participate in any other clinical study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Marc Kollum, PD Dr. med.	Hegau-Bodensee-Klinikum Singen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hegau-Bodensee-Klinikum Singen		Singen	Baden-Wurttemberg	78224	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36035510	Background	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.
40094912

ID	Term
D000086382	COVID-19
D009202	Cardiomyopathies

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections