COVID-19COR-DLUSNCT04351802
CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
An observational study of COVID-19, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Lung ultrasound
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2020to 15 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19
Who may be able to join
- Age greater than or equal to 18 years
- Suspected or confirmed diagnosis of COVID-19
- Able to provide informed consent to study participation
Who cannot join
- Age less than 18 years
- Inability to provide informed consent at the time of study enrolment
Trial locations and contacts
1 site in 1 country.
About this study
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
Read the detailed description
Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.
Participants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.
Participants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).
- Conditions
- COVID-19
- Being tested
- Lung ultrasound
- Keywords
- COVID-19, Lung Ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Focused lung ultrasound examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of COVID-19 on lung ultrasound
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound
Measured: On day of admission to hospital
Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings
Measured: On day of admission to hospital
Secondary outcomes (3)
Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray
Primary and blinded scorer diagnosis of alternative condition on lung ultrasound
Measured: On day of admission to hospital
Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19
Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirements
Measured: During hospital admission
Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19
Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis
Measured: On day of admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start11 May 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
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.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Corcoran, BMBCh MRCP, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351802
- Sponsor's protocol ID
- 282661
- Acronym
- COR-DLUS
- Status last verified
- Oct 2021
- First submitted
- 16 Apr 2020
- Last updated
- 15 Oct 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 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
- ClinicalTrials.gov ID
- NCT04351802
- Acronym / sponsor ID
- COR-DLUS / 282661
- Conditions
- COVID-19
- Keywords
- COVID-19, Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 17 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.
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
Detailed description
Study participants will be screened from and recruited on their entry into the suspected COVID-19 admission pathway at Derriford Hospital, Plymouth, UK. In addition to usual clinical care (including physical exam and observations, blood tests, nasopharyngeal swab for viral PCR testing, and chest x-ray as standard), participants will undergo focused lung ultrasound examination.
Participants who are negative for COVID-19 will be followed up to confirm their final discharge diagnoses, and clinical outcome at either 3 months post-enrolment or discharge from hospital.
Participants who are positive for COVID-19 will have regular focused lung ultrasound examination during their hospital admission in addition to usual clinical care until their treatment for COVID-19 is complete. Their discharge diagnoses and clinical outcome at either 3 months post-enrolment or discharge from hospital (whichever is later).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- Suspected or confirmed diagnosis of COVID-19
- Able to provide informed consent to study participation
Key exclusion criteria (2 listed)
- Age less than 18 years
- Inability to provide informed consent at the time of study enrolment
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 ultrasoundFocused lung ultrasound examination | Diagnostic test | – |
Primary outcome
Diagnosis of COVID-19 on lung ultrasound
Time frame: On day of admission to hospital
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound
Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray
Time frame: On day of admission to hospital
Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findings
3 secondary outcomes
Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray
Time frame: On day of admission to hospital
Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19
Time frame: During hospital admission
Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19
Time frame: On day of admission to hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
John P Corcoran, BMBCh MRCP principal investigator
University Hospital Plymouth NHS Trust
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 COVID-19, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 15 Oct 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnosis of COVID-19 on lung ultrasound (time frame: On day of admission to hospital). 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 15 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.