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Lung Ultrasound to Diagnose COVID-19 (COVILUS)

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: NCT04368338
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment
Covid-19 Lung Ultrasound Respiratory Complication Diagnostic Test: COVID-19 RT-PCR Procedure: lung ultrasound

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Lung Ultrasound in Patients Suspected of COVID-19 Infection in the Emergency Room
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : September 28, 2020
Estimated Study Completion Date : September 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: COVID-19 RT-PCR
    Polymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR)
  • Procedure: lung ultrasound
    lung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room


Primary Outcome Measures :
  1. Lung ultrasound/biological correlation research modulating the severity of Covid-19 disease [ Time Frame: 6 months ]
    Polymerase chain reaction tests after reverse transcription for the detection of covid-19 viral RNA will be done as biological test.



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.


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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
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT04368338


Contacts
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Contact: Stéphane Bar, MD 0322087906 bar.stephane@chu-amiens.fr

Locations
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France
BAR Recruiting
Amiens, France, 80054
Contact: Stéphane Bar, Dr    (33)322088371    bar.stephane@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Stéphane Bar, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04368338    
Other Study ID Numbers: PI2020_843_0030
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Covid-19
lung ultrasound
Respiratory Complication