CORonavirus (COVID-19) Diagnostic Lung UltraSound Study (COR-DLUS)

October 14, 2021 updated by: University Hospital Plymouth NHS Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On day of admission to hospital
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
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
Time Frame: On day of admission to hospital
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
Time Frame: During hospital admission
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
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
On day of admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John P Corcoran, BMBCh MRCP, University Hospitals Plymouth NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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