Trial document




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  DRKS00022409

Trial Description

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Title

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

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Trial Acronym

FSC19-KN

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URL of the Trial

http://www.ZKS-HegauBodensee.de

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022409
  •   2020/12/03
  •   [---]*
  •   yes
  •   Approved
  •   20-1020, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   COVID-19
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Interventions/Observational Groups

  •   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.
  •   Subjects without a positive SARS-CoV-2 test and without contact to SARS-CoV-2 positive patients receive a physical examination including measurement of the breathing rate, heart rate, blood pressure, oxygen saturation and a SARS-CoV-2 antibody test during the initial visit. 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)). 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.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Hospitalization (assessment of adverse events) on annually basis.

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Secondary Outcome

Quality of life measured by questionnaires EQ-5D-5L and Cardiomyopathy in Kansas City (KCCQ-12)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2021/01/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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

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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

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Addresses

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    • Hegau-Bodensee-Klinikum Singen
    • Mr.  PD Dr. med.  Marc  Kollum 
    • Virchow Str. 10
    • 78224  Singen am Hohentwiel
    • Germany
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    • Hegau-Bodensee-Klinikum Singen
    • Mr.  PD Dr. med.  Marc  Kollum 
    • Virchow Str. 10
    • 78224  Singen am Hohentwiel
    • Germany
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    • Hegau-Bodensee-Klinikum Singen
    • Mr.  PD Dr. med.  Marc  Kollum 
    • Virchow Str. 10
    • 78224  Singen am Hohentwiel
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.