CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung ultrasound|Focused lung ultrasound examination|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of COVID-19 on lung ultrasound | 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 | 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 | 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 | 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 | Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosis | On day of admission to hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Lung Ultrasound