- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351802
CORonavirus (COVID-19) Diagnostic Lung UltraSound Study (COR-DLUS)
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Devon
-
Plymouth, Devon, United Kingdom, PL6 8DH
- Derriford Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater than or equal to 18 years
- Suspected or confirmed diagnosis of COVID-19
- Able to provide informed consent to study participation
Exclusion Criteria:
- Age less than 18 years
- Inability to provide informed consent at the time of study enrolment
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
On day of admission to hospital
|
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
|
On day of admission to hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray
Time Frame: On day of admission to hospital
|
Primary and blinded scorer diagnosis of alternative condition on lung ultrasound
|
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
|
Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g.
supplementary oxygen requirements
|
During hospital admission
|
Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19
Time Frame: On day of admission to hospital
|
Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis
|
On day of admission to hospital
|
Collaborators and Investigators
Investigators
- Principal Investigator: John P Corcoran, BMBCh MRCP, University Hospitals Plymouth NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 282661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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