CoronavirusNCT04320732
Risk Factors for Community- and Workplace Transmission of COVID-19
An observational study of Coronavirus, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Observation of behavior and COVID-19 infection will be conducted.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250,000 participants
- Where
- 1 siteNorway
- Study dates
- 27 Mar 2020to 20 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Norwegian adult
Who cannot join
- Unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
John Arne Dahl, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Arne Søraas, PhD, +4790652904, Arne.Vasli.Lund.Soraas@rr-research.no
John A Dahl, PhD, +4741456596, j.a.dahl@medisin.uio.no
About this study
The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.
Read the 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.
- Conditions
- Coronavirus
- Being tested
- Observation of behavior and COVID-19 infection will be conducted.
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of behavior and COVID-19 infection will be conducted.Behavioural
No intervention, only prospective observation of behavior will be conducted by a questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Observation of behavior and COVID-19 infection will be conducted. | |
| Individuals tested for COVID-19 infection with negative test | Confirmed by routine laboratory diagnosis Receives: Behavioral: Observation of behavior and COVID-19 infection will be conducted. | |
| Healthy individuals | Recruitet from the general population Receives: Behavioral: Observation of behavior and COVID-19 infection will be conducted. | |
| Risk groups for COVID-19 exposure | Including, but not limited to healthcare workers. Receives: Behavioral: Observation of behavior and COVID-19 infection will be conducted. | |
| Patients admitted to hospital | Without COVID-19 infection. Receives: Behavioral: Observation of behavior and COVID-19 infection will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 infection
Diagnosed with serology or direct viral detection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start27 Mar 2020
- Primary completion27 Mar 2025 (estimated)
- Study completion20 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Age Labs AS
- Responsible party
- Principal investigator, Arne Vasli Lund Søraas, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320732
- Sponsor's protocol ID
- REK-124170
- Status last verified
- Nov 2021
- First submitted
- 23 Mar 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Community- and Workplace Transmission of COVID-19
- ClinicalTrials.gov ID
- NCT04320732
- Acronym / sponsor ID
- REK-124170
- Conditions
- Coronavirus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Age Labs AS
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 27 Mar 2025 (estimated)
- Study completion
- 20 Mar 2030 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Norwegian adult
Key exclusion criteria (1 listed)
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of behavior and COVID-19 infection will be conducted.No intervention, only prospective observation of behavior will be conducted by a questionnaire. | Behavioural | Healthy individuals, Individuals tested for COVID-19 infection with negative test, Individuals with COVID-19 infection, Patients admitted to hospital, Risk groups for COVID-19 exposure |
Primary outcome
Rate of COVID-19 infection
Time frame: 1 year
Diagnosed with serology or direct viral detection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Individual participant dataSharing planned: No. European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Arne Dahl, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arne Søraas, MD, PhD (+4790652904, Arne.Vasli.Lund.Soraas@rr-research.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of COVID-19 infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.