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NCT Number: NCT04724434

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

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.

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Key information

Conditions

SARS-CoV-2 Positive Patients COVID-19 Cardiomyopathies Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hegau-Bodensee-Klinikum Singen

Singen, Baden-Wurttemberg, 78224, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of Hospitalization

    Time frame: Between 1 year after enrollment and 5 years after last patient in

    Primary endpoint

Secondary outcomes

  1. EQ-5D-5L

    Time frame: Between 1 year after enrollment and 5 years after last patient in

    Secondary endpoint

  2. KCCQ-12

    Time frame: Between 1 year after enrollment and 5 years after last patient in

    Secondary endpoint

Sponsors and collaborators

Lead sponsor

Hegau-Bodensee-Klinikum Singen

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Acronym: FSC19-KN

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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