NCT04351802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

April 16, 2020

Last Update Submit

October 14, 2021

Conditions

Keywords

COVID-19Lung Ultrasound

Outcome Measures

Primary Outcomes (2)

  • Diagnosis of COVID-19 on lung ultrasound

    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

    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 Outcomes (3)

  • Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray

    On day of admission to hospital

  • 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

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

Focused lung ultrasound examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age greater than or equal to 18 years
  • Suspected or confirmed diagnosis of COVID-19
  • Able to provide informed consent to study participation

You may not qualify if:

  • Age less than 18 years
  • Inability to provide informed consent at the time of study enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • John P Corcoran, BMBCh MRCP

    University Hospitals Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 17, 2020

Study Start

May 11, 2020

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations