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

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04320732

Collaborator

Age Labs AS (Other)

250,000

Enrollment

Location

119.8

Anticipated Duration (Months)

2087.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 27, 2020

Anticipated Primary Completion Date :

Mar 27, 2025

Anticipated Study Completion Date :

Mar 20, 2030

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

Rate of COVID-19 infection [1 year]
Diagnosed with serology or direct viral detection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Norwegian adult

Exclusion Criteria:

Unable to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

Oslo University Hospital
Age Labs AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Mar 25, 2020

Last Update Posted:

Dec 13, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

Study Results

No Results Posted as of Dec 13, 2021