COVID-19COVIDUS-NORNCT04422691
Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection
An observational study of COVID-19 and Pneumonia, Viral, run by St. Olavs Hospital at 9 sites in Norway.
Trial summary
In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- COVID-19, Pneumonia, Viral, Pulmonary Infection
- What is being tested?
- Lung ultrasound
- How many people
- 5 participants
- Where
- 9 sitesNorway
- Study dates
- 1 Jul 2020to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pasients referred to the ED with signs and symptoms suspected of COVID-19 (including cough, dyspnea, fever), patient already diagnosed with COVID-19, and patients with risk of being in contact with corona virus will be eligible for study enrollment.
Who may be able to join
- All emergency department patients with suspected or diagnosed COVID-19.
Who cannot join
- Negative screening for COVID-19
- recent negative COVID-19 test
- no indication for isolation in the Emergency Department
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Haukeland universitetssykehus
Bergen
Nordland Hospital
Bodø
Drammen sykehus
Drammen
Sørlandet sykehus, Kristiansand
Kristiansand
Akershus University Hospital
Oslo
Ullevål University Hospital
Oslo
Sykehuset Telemark HF
Skien
Stavanger Universitetssjukehus
Stavanger
St Olavs Hospital
Trondheim
About this study
Official title: Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge
In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel.
The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.
- Conditions
- COVID-19, Pneumonia, Viral, Pulmonary Infection
- Being tested
- Lung ultrasound
- Keywords
- Ultrasonography, Norway, Emergency Department, Emergency Physicians
- Medical subject headings
- COVID-19, Pneumonia, Viral, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Also called Ultrasonography of the lungs
After verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 suspected | Emergency department patients with suspected or diagnosed COVID-19 disease. All patients will be screened at triage and put into isolation if suspected disease. Ultrasound of the patients lungs will be performed after patient consent and findings will be recorded and categorized (Soldati et al., 2020). The use of ultrasound and registration of data will not affect the regular patient evaluation, treatment or logistics. Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30-day mortality
Measured: up to 30 days
Level-of-care
In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
Measured: up to 7 days
Secondary outcomes (4)
In-hospital length of stay
in days
Measured: Up to 30 days
Oxygen usage in the emergency department
Measured: Within 24 hours
Emergency department length of stay
in hours
Measured: Within 24 hours
Antibiotics usage
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: lack of Covid-19 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by St. Olavs 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
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Ullevaal University Hospital, Nordlandssykehuset HF, Sorlandet Hospital HF, Drammen sykehus, Sykehuset Telemark, Helse Stavanger HF, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Lars Petter Bjørnsen, MD, PhD, Principal investigator, NTNU/St. Olav's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422691
- Sponsor's protocol ID
- REK129805
- Acronym
- COVIDUS-NOR
- Status last verified
- Jun 2021
- First submitted
- 5 Jun 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge
- ClinicalTrials.gov ID
- NCT04422691
- Acronym / sponsor ID
- COVIDUS-NOR / REK129805
- Conditions
- COVID-19, Pneumonia, Viral, Pulmonary Infection
- Keywords
- Ultrasonography, Norway, Emergency Department, Emergency Physicians
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of Covid-19 patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Ullevaal University Hospital, Nordlandssykehuset HF, Sorlandet Hospital HF, Drammen sykehus, Sykehuset Telemark, Helse Stavanger HF, University Hospital, Akershus
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 9 Jun 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.
In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel.
The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 suspected | – | Diagnostic Test: Lung ultrasoundEmergency department patients with suspected or diagnosed COVID-19 disease. All patients will be screened at triage and put into isolation if suspected disease. Ultrasound of the patients lungs will be performed after patient consent and findings will be recorded and categorized (Soldati et al., 2020). The use of ultrasound and registration of data will not affect the regular patient evaluation, treatment or logistics. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pasients referred to the ED with signs and symptoms suspected of COVID-19 (including cough, dyspnea, fever), patient already diagnosed with COVID-19, and patients with risk of being in contact with corona virus will be eligible for study enrollment.
Key inclusion criteria (1 listed)
- All emergency department patients with suspected or diagnosed COVID-19.
Key exclusion criteria (3 listed)
- Negative screening for COVID-19
- recent negative COVID-19 test
- no indication for isolation in the Emergency Department
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 |
|---|---|---|
| Lung ultrasoundAlso: Ultrasonography of the lungsAfter verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020. | Diagnostic test | Covid-19 suspected |
Primary outcome
Mortality
Time frame: up to 30 days
30-day mortality
Level-of-care
Time frame: up to 7 days
In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
4 secondary outcomes
In-hospital length of stay
Time frame: Up to 30 days
Oxygen usage in the emergency department
Time frame: Within 24 hours
Emergency department length of stay
Time frame: Within 24 hours
Antibiotics usage
Time frame: Within 24 hours
Results and safety
The study was stopped early (reason given: lack of Covid-19 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lars Petter Bjørnsen, MD, PhD principal investigator
NTNU/St. Olav's Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pneumonia, Viral, run by St. Olavs Hospital at 9 sites 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 3 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: stopped early, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study was stopped early (reason given: lack of Covid-19 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 30 days). The study lists 2 primary outcomes in all. 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 22 Jun 2021.