Trial document




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  DRKS00021306

Trial Description

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Title

Covid-19 Case-Cluster-Study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Epidemiological exposure data and biological samples will be systematically collected and analysed using a standardised protocol (as proposed by the World Health Organisation (WHO)) to provide estimates of the severity of infection and transmission rate/modalities of the COVID 19 virus.

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Brief Summary in Scientific Language

The aim of the "Covid-19 Case Cluster Study" is to investigate the prevalence of SARS/CoV-2-positive individuals (degree of infestation) in the population of a high-risk area, the virulence of infection with SARS/CoV-2 and the personal and environmental factors that correlate with the virulence of the virus. For this purpose, a representative sample of a region of the high-risk area of the Heinsberg district will be examined for SARS/CoV-2 infection and correlated with a series of anamnestic data. In addition, environmental diagnostics will be carried out on selected individuals to analyse the transmission pathways of the infection.
In addition to sampling, an extended questionnaire will be used to examine infection chains in the participants of the "Kappensitzung" and to determine the behaviour and characteristics of the persons that are decisive for infection.

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

Yes

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Description IPD sharing plan:

On request to the sponsor.

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Organizational Data

  •   DRKS00021306
  •   2020/04/14
  •   [---]*
  •   yes
  •   Approved
  •   Lfd. Nr. 085/20, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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

  •   COVID-19
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Index persons of the Gangelt register as well as household or family members: Collection of biological samples for virus diagnostics from the study participants:
    - adults: 3 EDTA tubes (10 ml), throat swab, spit (saliva)
    - Children: 1 EDTA tube (1 ml), throat swab, spit (saliva), handing out a study questionnaire
    In up to 50 selected households, further virological diagnostics, including the living environment, are to be used to evaluate the extent to which the virus can be transmitted to family members via air and the inanimate environment (surfaces, consumer goods, food, wastewater) and the living environment (pets)
  •   Participants of the "Kappenmeeting" residing in the Heinsberg district as well as household or family members: virus diagnostics like observation group 1 and extended questionnaire
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the prevalence of SARS/CoV-2 positive individuals in the study population, defined as the number of individuals with positive laboratory findings (from at least one of the sample media collected in the study) divided by the total number of study participants.

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Secondary Outcome

Secondary endpoints are
(i) the "level of infestation", defined as the sum of
a. prevalent persons, and
b. healthy individuals with previous positive laboratory findings (prior to the conduct of the study) with concurrent negative laboratory findings in the study, divided by the total number of study participants,
(ii) the rate of unreported cases, defined as the number of persons with positive laboratory results (in the study) but without previous positive laboratory results (before the study was conducted), divided by the total number of study participants,
(iii) the proportion of healthy individuals, defined as the number of individuals with previous positive laboratory results (before the study was conducted) with concurrent negative laboratory results in the study, divided by the total number of study participants,
(iv) the associations of the above measures with the symptoms reported in the questionnaire,
(v) the associations of the above measures with the personal factors recorded in the questionnaire,
(vi) the associations of the above measures with the personal and behavioural factors recorded in the expanded questionnaire; and
(vii) the associations of the above measures with the additional environmental factors collected in the selected households

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2020/03/31
  •   1400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Residence in the Heinsberg district
- Individual surname and random selection as index person (by sampling from the Gangelt municipal register) or participation in the "Kappensitzung"
- Household or family members of the index person/participants of the "Kappensitzung"

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Exclusion Criteria

None.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Virologie/ Universitätklinikum Bonn
    • Mr.  Prof. Dr.  Hendrik  Streeck 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Studienzentrale (SZB)/ Institut für Klinische Chemie und Klinische Pharmakologie/ Universitätsklinikum Bonn
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Institut für Virologie/ Universitätklinikum Bonn
    • Mr.  Prof. Dr.  Hendrik  Streeck 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Institut für Virologie/ Universitätklinikum Bonn
    • Mr.  Prof. Dr.  Hendrik  Streeck 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Arbeit, Gesundheit und Soziales NRW
    • Fürstenwall 25
    • 40219  Düsseldorf
    • Germany
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    •   02118555
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/06
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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.