Single Center Prospective Controlled Follow-up Study of COVID-19 Patients District Konstanz (FSC19-KN)
Organizational Data
- DRKS-ID:
- DRKS00022409
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2020-12-03
- Last update in DRKS:
- 2023-03-23
- Registration type:
- Prospective
Acronym/abbreviation of the study
FSC19-KN
URL of the study
http://www.ZKS-HegauBodensee.de
Brief summary in lay language
It is a prospective single-center research project for the follow-up of SARS-CoV-2 positive patients in the district of Konstanz. Currently, as part of the coronavirus (SARS-CoV-2) pandemic, patients with SARS-CoV-2 infection are inpatients in the clinics of the health network of the district of Konstanz with the locations Singen (Hegau-Bodensee Klinikum) and Konstanz (Konstanz Clinic) treated. So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part of this research project, the course of the disease in these patients should be monitored in order to identify and treat late complications at an early stage.
Brief summary in scientific language
Participants will be patients from the Constance district. Potential participants have given their consent to participate in the study. The patients are identified by the health department of the district of Konstanz. Patients with a positive molecular biological detection (PCR) for SARS-CoV-2 are included. The patients are written to and asked to give their consent to clinical follow-up. If the consent and the data protection release are available, the clinical parameters of the patients are recorded. For the control group, volunteer test persons are sought by newspaper advertisements or flyers and their consent to participate is obtained. The patients and test persons are invited to an initiation visit. Standardized clinical parameters are collected, the questionnaires are filled out together and a SARS-CoV-2 antibody test is carried out. The follow-up period is 5 years, whereby the clinical events (hospitalization) are queried annually by telephone and the questionnaires are documented in the telephone interview.
Health condition or problem studied
- Free text:
- COVID 19
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- SARS-CoV-2 positive patients receive a physical examination including measurement of breathing rate, heart rate, blood pressure, oxygen saturation and a SARS-CoV-2 antibody test during the initial visit. In addition, a 6-minute walking test is performed and the patient answers 2 questionnaires (EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)). During the annual surveys, the need for hospitalization is asked by telephone and the 2 questionnaires (EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)) are filled out.
- Arm 2:
- Subjects without a positive SARS-CoV-2 test and without contact with SARS-CoV-2 positive patients will receive a physical examination at the initial visit including measurement of respiratory rate, heart rate, blood pressure, oxygen saturation, a SARS-CoV-2 antibody test. In addition, a 6-minute walk test is performed and the patient answers 2 questionnaires (EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)). At the annual interviews, the need for hospitalisation is asked by telephone and the 2 questionnaires (EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)) are completed.
Endpoints
- Primary outcome:
- Hospitalisation and recording of diseases on an annual basis (1-5 years after study inclusion).
- Secondary outcome:
- Quality of life measured by questionnaires EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Hegau-Bodensee Klinikum Singen Singen am Hohentwiel
Recruitment period and number of participants
- Planned study start date:
- 2021-01-01
- Actual study start date:
- 2021-01-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 400
- Final Sample Size:
- 526
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 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 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
Exclusion Criteria for all Participants 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
Addresses
Primary Sponsor
- Address:
- Hegau-Bodensee-Klinikum SingenPD Dr. med. Marc KollumVirchow Str. 1078224 Singen am HohentwielGermany
- Telephone:
- 07731/89-2600
- Fax:
- 07731/89-2605
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.glkn.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Hegau-Bodensee-Klinikum SingenPD Dr. med. Marc KollumVirchow Str. 1078224 Singen am HohentwielGermany
- Telephone:
- 07731/89-2600
- Fax:
- 07731/89-2605
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.glkn.de
Contact for Public Queries
- Address:
- Hegau-Bodensee-Klinikum SingenPD Dr. med. Marc KollumVirchow Str. 1078224 Singen am HohentwielGermany
- Telephone:
- 07731/89-2600
- Fax:
- 07731/89-2605
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.glkn.de
Principal Investigator
- Address:
- Hegau-Bodensee-Klinikum SingenPD Dr. med. Marc KollumVirchow Str. 1078224 Singen am HohentwielGermany
- Telephone:
- 07731/89-2600
- Fax:
- 07731/89-2605
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.glkn.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-07-24
- Ethics committee number:
- 20-1020
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-11-05
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry