COVID-19 PneumoniaSCOUTNCT04338568
Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study
A study testing Lung ultrasound in people with COVID-19 Pneumonia and Lung Ultrasound, run by Hasselt University at 1 site in Belgium.
Trial summary
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Lung Ultrasound
- What is being tested?
- Lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2020to 30 Dec 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
- positive COVID-19 nasopharyngeal swab within 10 days of inclusion
- 18 years or older
- Oxygen saturation of < 93% in ambient air
- Signed written informed consent
Who cannot join
- Contra-indication for lung ultrasound
- Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost Limburg
Genk, Limburg, 3600
Michiel J Thomeer, MD, PhD, +3289327171, michiel.thomeer@zol.be
Inge Thijs, PhD, +3289212007, Inge.Thijs@zol.be
About this study
Official title: Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection.
This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.
- Conditions
- COVID-19 Pneumonia, Lung Ultrasound
- Being tested
- Lung ultrasound
- Keywords
- accuracy, inter-observer variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
The lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position.
| Study group | Role | What they receive |
|---|---|---|
| LUS observer 1 | Active comparator | The subject will undergo a Lung Ultrasound by observer nr 1 Receives: Diagnostic Test: Lung ultrasound |
| LUS observer 2 | Active comparator | The subject will undergo a Lung Ultrasound by observer nr 2 Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound
The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.
Measured: within 2 weeks after first subject included
Inter-observer variability
The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is > 0.6 measured by the Kappa score
Measured: within 2 weeks after first subject included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start16 Apr 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients with the diagnosis of COVID-19 pneumonia will undergo a lung ultrasound, by two observers each. The findings will be compared with findings on chest x-ray and/or CT thorax. Accuracy and inter-observer variability will be calculated.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Prof. dr. Michiel Thomeer, Hasselt University
- Investigators
- Michiel Thomeer, MD,PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338568
- Sponsor's protocol ID
- CTU2020032
- Acronym
- SCOUT
- Status last verified
- Aug 2020
- First submitted
- 4 Apr 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Ramirez P, Torres A. Should ultrasound be included in the initial assessment of respiratory patients? Lancet Respir Med. 2014 Aug;2(8):599-600. doi: 10.1016/S2213-2600(14)70142-0. Epub 2014 Jul 3. No abstract available.
PubMed 24998675Pisani L, Vercesi V, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MAM, Henwood PC, Walden A, Smit MR, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. The diagnostic accuracy for ARDS of global versus regional lung ultrasound scores - a post hoc analysis of an observational study in invasively ventilated ICU patients. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):44. doi: 10.1186/s40635-019-0241-6.
PubMed 31346914Li K, Fang Y, Li W, Pan C, Qin P, Zhong Y, Liu X, Huang M, Liao Y, Li S. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol. 2020 Aug;30(8):4407-4416. doi: 10.1007/s00330-020-06817-6. Epub 2020 Mar 25.
PubMed 32215691
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04338568
- Acronym / sponsor ID
- SCOUT / CTU2020032
- Conditions
- COVID-19 Pneumonia, Lung Ultrasound
- Keywords
- accuracy, inter-observer variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 8 Apr 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.
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection.
This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with the diagnosis of COVID-19 pneumonia will undergo a lung ultrasound, by two observers each. The findings will be compared with findings on chest x-ray and/or CT thorax. Accuracy and inter-observer variability will be calculated.
| Arm | Type | Receives |
|---|---|---|
| LUS observer 1 | Active comparator | Diagnostic Test: Lung ultrasoundThe subject will undergo a Lung Ultrasound by observer nr 1 |
| LUS observer 2 | Active comparator | Diagnostic Test: Lung ultrasoundThe subject will undergo a Lung Ultrasound by observer nr 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
- positive COVID-19 nasopharyngeal swab within 10 days of inclusion
- 18 years or older
- Oxygen saturation of < 93% in ambient air
- Signed written informed consent
Key exclusion criteria (2 listed)
- Contra-indication for lung ultrasound
- Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray
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 ultrasoundThe lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position. | Diagnostic test | LUS observer 1, LUS observer 2 |
Primary outcome
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound
Time frame: within 2 weeks after first subject included
The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.
Inter-observer variability
Time frame: within 2 weeks after first subject included
The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is > 0.6 measured by the Kappa score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Background: PubMed 24998675Ramirez P, Torres A. Should ultrasound be included in the initial assessment of respiratory patients? Lancet Respir Med. 2014 Aug;2(8):599-600. doi: 10.1016/S2213-2600(14)70142-0. Epub 2014 Jul 3. No abstract available.
- Results publication: PubMed 31346914Pisani L, Vercesi V, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MAM, Henwood PC, Walden A, Smit MR, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. The diagnostic accuracy for ARDS of global versus regional lung ultrasound scores - a post hoc analysis of an observational study in invasively ventilated ICU patients. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):44. doi: 10.1186/s40635-019-0241-6.
- Results publication: PubMed 32215691Li K, Fang Y, Li W, Pan C, Qin P, Zhong Y, Liu X, Huang M, Liao Y, Li S. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol. 2020 Aug;30(8):4407-4416. doi: 10.1007/s00330-020-06817-6. Epub 2020 Mar 25.
- Individual participant dataSharing planned: No. no plan
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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.
Michiel Thomeer, MD,PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound in people with COVID-19 Pneumonia and Lung Ultrasound, run by Hasselt University at 1 site in Belgium.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Aug 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michiel J Thomeer, MD,PhD (+3289327171, michiel.thomeer@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound (time frame: within 2 weeks after first subject included). 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?
On the ClinicalTrials.gov record for NCT04338568, which also lists 3 linked publications.
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 17 Aug 2020.