CORonavirus (COVID-19) Diagnostic Lung UltraSound Study (COR-DLUS)
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|ClinicalTrials.gov Identifier: NCT04351802|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment|
|COVID-19||Diagnostic Test: Lung ultrasound|
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 :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||CORonavirus (COVID-19) Diagnostic Lung UltraSound Study|
|Estimated Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||January 20, 2021|
|Estimated Study Completion Date :||January 20, 2021|
- Diagnostic Test: Lung ultrasound
Focused lung ultrasound examination
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351802
|Contact: UHPNT Research & Development Office||+44 (0)1752 432842||plh-tr.RD-Office@nhs.net|
|Principal Investigator:||John P Corcoran, BMBCh MRCP||University Hospitals Plymouth NHS Trust|