- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04320732
Risk Factors for Community- and Workplace Transmission of COVID-19
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Arne Søraas, MD, PhD
- Telefoonnummer: +4790652904
- E-mail: Arne.Vasli.Lund.Soraas@rr-research.no
Studie Contact Back-up
- Naam: John Arne Dahl, PhD
- E-mail: j.a.dahl@medisin.uio.no
Studie Locaties
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Oslo, Noorwegen, 0424
- Werving
- Oslo University Hospital
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Contact:
- John A Dahl, PhD
- Telefoonnummer: +4741456596
- E-mail: j.a.dahl@medisin.uio.no
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- Norwegian adult
Exclusion Criteria:
- Unable to consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of COVID-19 infection
Tijdsspanne: 1 year
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Diagnosed with serology or direct viral detection
|
1 year
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REK-124170
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .