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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04320732
Other study ID # REK-124170
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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