- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04320732
Risk Factors for Community- and Workplace Transmission of COVID-19
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Arne Søraas, MD, PhD
- Telefonnummer: +4790652904
- E-mail: Arne.Vasli.Lund.Soraas@rr-research.no
Undersøgelse Kontakt Backup
- Navn: John Arne Dahl, PhD
- E-mail: j.a.dahl@medisin.uio.no
Studiesteder
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Oslo, Norge, 0424
- Rekruttering
- Oslo University Hospital
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Kontakt:
- John A Dahl, PhD
- Telefonnummer: +4741456596
- E-mail: j.a.dahl@medisin.uio.no
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- Norwegian adult
Exclusion Criteria:
- Unable to consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Individuals tested for COVID-19 infection with negative test
Confirmed by routine laboratory diagnosis
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Healthy individuals
Recruitet from the general population
|
No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Risk groups for COVID-19 exposure
Including, but not limited to healthcare workers.
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Patients admitted to hospital
Without COVID-19 infection.
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No intervention, only prospective observation of behavior will be conducted by a questionnaire.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of COVID-19 infection
Tidsramme: 1 year
|
Diagnosed with serology or direct viral detection
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REK-124170
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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