Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351802
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

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.

Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: Lung ultrasound

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CORonavirus (COVID-19) Diagnostic Lung UltraSound Study
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : January 20, 2021



Intervention Details:
  • Diagnostic Test: Lung ultrasound
    Focused lung ultrasound examination


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (greater than or equal to 18 years in age) presenting with suspected COVID-19
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351802


Contacts
Layout table for location contacts
Contact: UHPNT Research & Development Office +44 (0)1752 432842 plh-tr.RD-Office@nhs.net

Sponsors and Collaborators
University Hospital Plymouth NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: John P Corcoran, BMBCh MRCP University Hospitals Plymouth NHS Trust
Layout table for additonal information
Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT04351802    
Other Study ID Numbers: 282661
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Plymouth NHS Trust:
COVID-19
Lung Ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases