| Registry | NCT04320732 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 250000 (Estimated) |
| Sponsor | Oslo University Hospital (Other); collaborators: Age Labs AS |
| Conditions | Coronavirus |
| Interventions | Observation of behavior and COVID-19 infection will be conducted. (Behavioral) |
| Dates | start 2020-03-27, primary completion 2025-03-27 (estimated), completion 2030-03-20 (estimated), first posted 2020-03-25, last updated 2021-12-13 |
| Locations | 1 site in Norway |
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All trials for Coronavirus All trials of Observation of behavior and COVID-19 infection will be conducted.
The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Individuals with COVID-19 infection | Behavioral: Observation of behavior and COVID-19 infection will be conducted. | 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. | |
| Individuals tested for COVID-19 infection with negative test | Behavioral: Observation of behavior and COVID-19 infection will be conducted. | Confirmed by routine laboratory diagnosis | |
| Healthy individuals | Behavioral: Observation of behavior and COVID-19 infection will be conducted. | Recruitet from the general population | |
| Risk groups for COVID-19 exposure | Behavioral: Observation of behavior and COVID-19 infection will be conducted. | Including, but not limited to healthcare workers. | |
| Patients admitted to hospital | Behavioral: Observation of behavior and COVID-19 infection will be conducted. | Without COVID-19 infection. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Norwegian adult Exclusion Criteria: * Unable to consent
| Facility | City | Country | Status |
|---|---|---|---|
| Oslo University Hospital | Oslo | Norway | Recruiting |