Covid19COVILUS2NCT04666064
Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room
An observational study of Covid19 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
- Covid19, Lung Ultrasound, Respiratory Complication
- What is being tested?
- Covid19 RT-PCR and lung ultrasound
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2020to 28 Apr 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 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 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Covid19 RT-PCR, lung ultrasound
- Keywords
- Covid19, lung ultrasound, Respiratory Complication, triage
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid19 RT-PCRDiagnostic test
patients admitted to ER for suspicion of COVID-19 infection will have a SARS-CoV-2 RT-PCR test
lung ultrasoundOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between Covid19 RT-PCR results and lung ultrasound results
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start10 Dec 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666064
- Sponsor's protocol ID
- PI2020_843_0129
- Acronym
- COVILUS2
- Status last verified
- Jul 2021
- First submitted
- 11 Dec 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
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
- Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room
- ClinicalTrials.gov ID
- NCT04666064
- Acronym / sponsor ID
- COVILUS2 / PI2020_843_0129
- Conditions
- Covid19, Lung Ultrasound, Respiratory Complication
- Keywords
- Covid19, lung ultrasound, Respiratory Complication, triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 14 Dec 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. 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.
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 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 (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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))
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 |
|---|---|---|
| Covid19 RT-PCRpatients admitted to ER for suspicion of COVID-19 infection will have a SARS-CoV-2 RT-PCR test | Diagnostic test | – |
| lung ultrasoundpatients 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 | Other | – |
Primary outcome
concordance between Covid19 RT-PCR results and lung ultrasound results
Time frame: one week
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 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 2 inclusion and 7 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?
concordance between Covid19 RT-PCR results and lung ultrasound results (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.