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

Coronavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320732
• Other study ID #: REK-124170
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: March 20, 2030

Study information

• Verified date: November 2021
• Source: Oslo University Hospital
• Contact: Arne Søraas, MD, PhD
• Phone: +4790652904
• Email: Arne.Vasli.Lund.Soraas[@]rr-research.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250000
• Est. completion date: March 20, 2030
• Est. primary completion date: March 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Norwegian adult

Exclusion Criteria:

• Unable to consent

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Age Labs AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of COVID-19 infection	Diagnosed with serology or direct viral detection	1 year