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

NCT04666064 | Completed

• 1 other identifier: PI2020_843_0129
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Lung Ultrasound; Respiratory Complication

Keywords

Covid19; lung ultrasound; Respiratory Complication; triage

Outcome Measures

Primary Outcomes (1)

• concordance between Covid19 RT-PCR results and lung ultrasound results

  one week

Interventions

Covid19 RT-PCR DIAGNOSTIC_TEST

patients admitted to ER for suspicion of COVID-19 infection will have a SARS-CoV-2 RT-PCR test

lung ultrasound OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

BAR

Amiens, 80054, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 14, 2020
• Study Start: December 10, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)