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Risk Factors for Community- and Workplace Transmission of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320732
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Age Labs AS
Information provided by (Responsible Party):
Arne Vasli Lund Søraas, Oslo University Hospital

Tracking Information
First Submitted Date March 23, 2020
First Posted Date March 25, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date March 27, 2020
Estimated Primary Completion Date March 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2020)
Rate of COVID-19 infection [ Time Frame: 1 year ]
Diagnosed with serology or direct viral detection
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Community- and Workplace Transmission of COVID-19
Official Title Risk Factors for Community- and Workplace Transmission of COVID-19
Brief Summary The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.
Detailed Description

Summary The data collected will identify real-life risk factors for getting the COVID-19 diagnosis.

The Oslo University Hospital/University of Oslo web-based solution "nettskjema" will be used to collect data and consent forms.

The impact of knowing the risk factors for COVID-19 is tremendous because it can enable governments to conduct more targeted public health measurements than today to reduce the spread of the virus.

Detailed description Research into an ongoing COVID-19 outbreak is difficult because patients are isolated, and supplies of personal protective equipment (PPE) supplies are limited. The risk of transmission to study personal is non-negligible even when PPE is available.

A study design based on an electronic questionnaire and consent from delivered from the Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant "TSD" service has therefore been chosen.

The study will be a case-control study based on a combined electronic consent form and questionnaire that the participants will fill in using a smartphone and electronic identification.

The groups that will be included are:

  • Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease
  • Hospitalized patients without COVID-19
  • Healthcare personal or other groups with an increased risk of COVID-19
  • Healthy volunteers

Participants may be followed with repeated questionnaires prospectively.

Biological samples Biological samples may hold crucial information about the susceptibility to COVID-19 and for susceptibility to the progression of the disease. It is within the scope of the study to analyze such samples from a limited number of participants which will be asked to provide such samples or hospitalized patients that have surplus material. The material will be analyzed with non-genetic methods most suitable to provide such information.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and upper repiratory samples will be collected from some participants.
Sampling Method Probability Sample
Study Population

The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification.

The groups that will be included are:

  • Hospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease
  • Hospitalized patients without COVID-19
  • Healthcare personal or other groups with an increased risk of COVID-19
  • Healthy volunteers

Probability sampling will be conducted, but not solely.

Condition Coronavirus
Intervention Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.
Study Groups/Cohorts
  • Individuals with COVID-19 infection

    Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included.

    Only subjects >18 years old will be included in the study.

    Intervention: Behavioral: Observation of behavior and COVID-19 infection will be conducted.
  • Individuals tested for COVID-19 infection with negative test
    Confirmed by routine laboratory diagnosis
    Intervention: Behavioral: Observation of behavior and COVID-19 infection will be conducted.
  • Healthy individuals
    Recruitet from the general population
    Intervention: Behavioral: Observation of behavior and COVID-19 infection will be conducted.
  • Risk groups for COVID-19 exposure
    Including, but not limited to healthcare workers.
    Intervention: Behavioral: Observation of behavior and COVID-19 infection will be conducted.
  • Patients admitted to hospital
    Without COVID-19 infection.
    Intervention: Behavioral: Observation of behavior and COVID-19 infection will be conducted.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 24, 2020)
250000
Original Estimated Enrollment
 (submitted: March 23, 2020)
50000
Estimated Study Completion Date March 20, 2030
Estimated Primary Completion Date March 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Norwegian adult

Exclusion Criteria:

  • Unable to consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Arne Søraas, MD, PhD +4790652904 Arne.Vasli.Lund.Soraas@rr-research.no
Contact: John Arne Dahl, PhD j.a.dahl@medisin.uio.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT04320732
Other Study ID Numbers REK-124170
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.
Responsible Party Arne Vasli Lund Søraas, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Age Labs AS
Investigators Not Provided
PRS Account Oslo University Hospital
Verification Date June 2020