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Clinical Trials/NCT04351802
NCT04351802
Completed
Not Applicable

CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

University Hospital Plymouth NHS Trust1 site in 1 country45 target enrollmentMay 11, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
University Hospital Plymouth NHS Trust
Enrollment
45
Locations
1
Primary Endpoint
Diagnosis of COVID-19 on lung ultrasound
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
February 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Plymouth NHS Trust
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19(During hospital admission)
  • Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19(On day of admission to hospital)
  • Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray(On day of admission to hospital)

Study Sites (1)

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