SARS-CoV-2 Positive PatientsFSC19-KNNCT04724434
Follow-up Study of COVID-19 Patients in the District Konstanz
An observational study of SARS-CoV-2 Positive Patients, run by Hegau-Bodensee-Klinikum Singen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Positive Patients
- How many people
- 526 participants
- Where
- 1 siteGermany
- Study dates
- 4 Dec 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Show all 9Show fewer
- No contact to SARS-CoV-2 positive patients
- negative SARS-CoV-2 antibody test
- Signed informed consent and privacy policy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)
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.
- 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)
- Medical subject headings
- COVID-19, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with positive test for SARS-CoV-2 by PCR | |
| Control group | Patients with negative SARS-CoV-2 antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hospitalization
Primary endpoint
Measured: Between 1 year after enrollment and 5 years after last patient in
Secondary outcomes (2)
EQ-5D-5L
Secondary endpoint
Measured: Between 1 year after enrollment and 5 years after last patient in
KCCQ-12
Secondary endpoint
Measured: Between 1 year after enrollment and 5 years after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start4 Dec 2020
- Primary completion17 Jul 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Positive PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hegau-Bodensee-Klinikum Singen
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, PD Dr. med. Marc Kollum, Hegau-Bodensee-Klinikum Singen
- Investigators
- Marc Kollum, PD Dr. med., Principal investigator, Hegau-Bodensee-Klinikum Singen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724434
- Sponsor's protocol ID
- 20-1020
- Acronym
- FSC19-KN
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36035510Kohler AK, Richter S, Schmid M, Zimmermann H, Winterer H, Schneider S, Kollum M. Three-Year Follow-Up of COVID-19 Cases in District of Constance, Germany. A Prospective, Controlled Cohort Study (FSC19-KN). J Clin Med. 2025 Feb 21;14(5):1439. doi: 10.3390/jcm14051439.
PubMed 40094912
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Prospective Controlled Follow-up Study of COVID-19 Patients in the District Konstanz (FSC19-KN)
- ClinicalTrials.gov ID
- NCT04724434
- Acronym / sponsor ID
- FSC19-KN / 20-1020
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Hegau-Bodensee-Klinikum SingenUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with positive test for SARS-CoV-2 by PCR |
| Control group | – | –Patients with negative SARS-CoV-2 antibody test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (9 listed)
- Patient must meet all of the following criteria.
- Positive test for SARS-CoV-2 by PCR
- Signed informed consent and privacy policy
- Volunteer must meet all of the following criteria.
- No contact to SARS-CoV-2 positive patients
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Hospitalization
Time frame: Between 1 year after enrollment and 5 years after last patient in
Primary endpoint
2 secondary outcomes
EQ-5D-5L
Time frame: Between 1 year after enrollment and 5 years after last patient in
KCCQ-12
Time frame: Between 1 year after enrollment and 5 years after last patient in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 36035510Haberland 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.
- Background: PubMed 40094912Kohler AK, Richter S, Schmid M, Zimmermann H, Winterer H, Schneider S, Kollum M. Three-Year Follow-Up of COVID-19 Cases in District of Constance, Germany. A Prospective, Controlled Cohort Study (FSC19-KN). J Clin Med. 2025 Feb 21;14(5):1439. doi: 10.3390/jcm14051439.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kollum, PD Dr. med. principal investigator
Hegau-Bodensee-Klinikum Singen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Positive Patients, run by Hegau-Bodensee-Klinikum Singen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hospitalization (time frame: Between 1 year after enrollment and 5 years after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.