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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 : March 31, 2020
Sponsor:
Collaborator:
Age Labs AS
Information provided by (Responsible Party):
Arne Vasli Lund Søraas, Oslo University Hospital

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.

Condition or disease Intervention/treatment
Coronavirus Behavioral: Observation of behavior and COVID-19 infection will be conducted.

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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors for Community- and Workplace Transmission of COVID-19
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : March 27, 2022
Estimated Study Completion Date : March 20, 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.

Individuals tested for COVID-19 infection with negative test
Confirmed by routine laboratory diagnosis
Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.

Healthy individuals
Recruitet from the general population
Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.

Risk groups for COVID-19 exposure
Including, but not limited to healthcare workers.
Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.

Patients admitted to hospital
Without COVID-19 infection.
Behavioral: Observation of behavior and COVID-19 infection will be conducted.
No intervention, only prospective observation of behavior will be conducted by a questionnaire.




Primary Outcome Measures :
  1. Rate of COVID-19 infection [ Time Frame: 1 year ]
    Diagnosed with serology or direct viral detection


Biospecimen Retention:   Samples With DNA
Blood and upper repiratory samples will be collected from some participants.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Norwegian adult

Exclusion Criteria:

  • Unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320732


Contacts
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Contact: Arne Søraas, MD, PhD +4790652904 Arne.Vasli.Lund.Soraas@rr-research.no
Contact: John Arne Dahl, PhD j.a.dahl@medisin.uio.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Arne Søraas, PhD    +4790652904    Arne.Vasli.Lund.Soraas@rr-research.no   
Contact: John A Dahl, PhD    +4741456596    j.a.dahl@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Age Labs AS
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Responsible Party: Arne Vasli Lund Søraas, Principal Investigator, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04320732    
Other Study ID Numbers: REK-124170
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases