Covid-19COVILUSNCT04368338
Lung Ultrasound to Diagnose COVID-19
An observational study of Covid-19 and Lung Ultrasound, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Lung Ultrasound, Respiratory Complication
- What is being tested?
- COVID-19 RT-PCR and lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2020to 20 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Lung Ultrasound in Patients Suspected of COVID-19 Infection in the Emergency Room
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.
- Conditions
- Covid-19, Lung Ultrasound, Respiratory Complication
- Being tested
- COVID-19 RT-PCR, lung ultrasound
- Keywords
- Covid-19, lung ultrasound, Respiratory Complication
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 RT-PCRDiagnostic test
Polymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR)
lung ultrasoundProcedure or surgery
lung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start28 Apr 2020
- Primary completion28 Jan 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Bar, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368338
- Sponsor's protocol ID
- PI2020_843_0030
- Acronym
- COVILUS
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32520406
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lung Ultrasound in Patients Suspected of COVID-19 Infection in the Emergency Room
- ClinicalTrials.gov ID
- NCT04368338
- Acronym / sponsor ID
- COVILUS / PI2020_843_0030
- Conditions
- Covid-19, Lung Ultrasound, Respiratory Complication
- Keywords
- Covid-19, lung ultrasound, Respiratory Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 RT-PCRPolymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR) | Diagnostic test | – |
| lung ultrasoundlung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 32520406Bar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Bar, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Lung Ultrasound, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound/biological correlation research modulating the severity of Covid-19 disease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.