CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

COVID-19 Clinical Trial

— COR-DLUS  

Official title:

CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351802
• Other study ID #: 282661
• Status: Completed
• Start date: May 11, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: October 2021
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Lung ultrasound
Focused lung ultrasound examination

Locations

Country	Name	City	State
United Kingdom	Derriford Hospital	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of COVID-19 on lung ultrasound	Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound	On day of admission to hospital
Primary	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	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
Secondary	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
Secondary	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