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Completed

NCT Number: NCT04351802

CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Ultrasound

Diagnostic Test

Focused lung ultrasound examination

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Acronym: COR-DLUS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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