CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

NCT ID: NCT04351802

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-02-15

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).

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lung ultrasound

Focused lung ultrasound examination

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P Corcoran, BMBCh MRCP

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Plymouth NHS Trust

Locations

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Derriford Hospital

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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282661

Identifier Type: -

Identifier Source: org_study_id