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

Covid19 Clinical Trial

— COVILUS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666064
• Other study ID #: PI2020_843_0129
• Status: Completed
• Start date: December 10, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Emergencies
• Lung Ultrasound
• Respiratory Complication

Intervention

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

Locations

Country	Name	City	State
France	BAR	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance between Covid19 RT-PCR results and lung ultrasound results		one week