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Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room (COVILUS2)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666064
Recruitment Status : Completed
First Posted : December 14, 2020
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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. The investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (COVILUS score) could predict the occurrence of a positive RT-PCR in patients suspected of COVID-19 infection admitted to the emergency room. The investigators are going to conduct a new study to validate this COVILUS score in this type of patient. The main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected COVID19 infection.

Condition or disease Intervention/treatment
Covid19 Lung Ultrasound Respiratory Complication Diagnostic Test: Covid19 RT-PCR Other: lung ultrasound

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room
Actual Study Start Date : December 10, 2020
Actual Primary Completion Date : April 28, 2021
Actual Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Covid19 RT-PCR
    patients admitted to ER for suspicion of COVID-19 infection will have a SARS-CoV-2 RT-PCR test
  • Other: lung ultrasound
    patients admitted to 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

Outcome Measures
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Primary Outcome Measures :
  1. concordance between Covid19 RT-PCR results and lung ultrasound results [ Time Frame: one week ]

Eligibility Criteria
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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 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 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
  • Age> 18 years old

Exclusion Criteria:

  • patients < 18 years of age
  • patients 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))
  • patients with chronic interstitial lung disease
  • patients who will refuse to give their consent.
Contacts and Locations
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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): NCT04666064


Locations
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France
BAR
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04666064    
Other Study ID Numbers: PI2020_843_0129
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
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:
Covid19
lung ultrasound
Respiratory Complication
triage
Additional relevant MeSH terms:
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COVID-19
Emergencies
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes