Clinical trial NCT04351802: CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
Official title: CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Lung Ultrasound
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of COVID-19 on lung ultrasound
timeFrame: On day of admission to hospital
measure: Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray
timeFrame: On day of admission to hospital
Secondary outcomes:
measure: Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray
timeFrame: On day of admission to hospital
measure: Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19
timeFrame: During hospital admission
measure: Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19
timeFrame: On day of admission to hospital
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
Study officials:
affiliation: University Hospitals Plymouth NHS Trust
name: John P Corcoran, BMBCh MRCP
role: PRINCIPAL_INVESTIGATOR
References: