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

The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 250000

Contacts and Locations

• Study Contact: Name: Arne Søraas, MD, PhD; Phone Number: +4790652904; Email: Arne.Vasli.Lund.Soraas@rr-research.no
• Study Contact Backup: Name: John Arne Dahl, PhD; Email: j.a.dahl@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: John A Dahl, PhD; Phone Number: +4741456596; Email: j.a.dahl@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Norwegian adult

Exclusion Criteria:

• Unable to consent

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of COVID-19 infection	Diagnosed with serology or direct viral detection	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Age Labs AS

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): March 27, 2025
• Study Completion (Anticipated): March 20, 2030

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: REK-124170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No