NCT04368338

Brief Summary

Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. During the COVID-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected COVID-19 infection admitted in ER. In addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. The objective of this project will be to study the association between the signs on lung ultrasound and the result of RT-PCR in patients with suspected COVID-19 infection in the ER.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

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 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

April 28, 2020

Last Update Submit

July 20, 2021

Conditions

Keywords

Covid-19lung ultrasoundRespiratory Complication

Outcome Measures

Primary Outcomes (1)

  • Lung ultrasound/biological correlation research modulating the severity of Covid-19 disease

    Polymerase chain reaction tests after reverse transcription for the detection of covid-19 viral RNA will be done as biological test.

    6 months

Interventions

COVID-19 RT-PCRDIAGNOSTIC_TEST

Polymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR)

lung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room

Eligibility Criteria

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

Patients admitted to Emergency Room (ER) for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound as part of the BLUE protocol.

You may qualify if:

  • patients admitted to Emergency Room for suspicion of COVID-19 infection with has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound

You may not qualify if:

  • patients \< 18 years of age or under guardianship or curators,
  • pregnancy
  • poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.)
  • patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS))
  • chronic interstitial lung disease
  • patients who will refuse to give their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAR

Amiens, 80054, France

Location

Related Publications (1)

  • Bar S, Lecourtois A, Diouf M, Goldberg E, Bourbon C, Arnaud E, Domisse L, Dupont H, Gosset P. The association of lung ultrasound images with COVID-19 infection in an emergency room cohort. Anaesthesia. 2020 Dec;75(12):1620-1625. doi: 10.1111/anae.15175. Epub 2020 Jul 1.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Stéphane Bar, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 29, 2020

Study Start

April 28, 2020

Primary Completion

January 28, 2021

Study Completion

July 20, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations