SARS-CoV2 InfectionESADECNCT04953091
Evaluation of the Sofia SARS Antigen FIA Assay for COVID-19
An observational study of SARS-CoV2 Infection, run by University Hospital, Brest at 2 sites in France.
Trial summary
Evaluating the performance of the Sofia SARS Antigen FIA Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 12 May 2021to 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two nasopharyngeal swabs will be taken per included patient. One will be analyzed by RT-PCR in the virology laboratory, the other will be analyzed on site with the Sofia SARS Antigen FIA test. The results of the two tests will then be compared. These samples will not be collected for further research.
Who may be able to join
- Adult patient (> or = 18 years of age)
- Patient with symptoms of COVID-19 (Rhinitis, throat pain, nasal congestion or other signs of local manifestation of the disease in the upper respiratory tract, including loss of taste, with or without additional systemic symptoms such as fatigue, fever, muscle pain...) whose health condition does not require hospitalization (mild to moderate disease)
- Patient with these symptoms for 5 days or less with a median of 3 to 4 days.
- Patient with consent to participate in the study
Who cannot join
- Patient with an age below 18 years
- Patient under legal protection (guardianship, curatorship)
- Patient without upper respiratory tract symptoms
- Patients with symptoms for more than 5 days
- Patient with previous COVID-19 diagnosed by RT-PCR
- Patient vaccinated against SARS-CoV-2 (1 or 2 injections)
- Hospitalized patient
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre de dépistage - CHRU BREST
Brest, 29200
Adissa TRAN, 0298145096
- Not yet recruiting
CHRU de brest
Brest, 29609
Adissa Tran, adissa.tran-minoui@chu-brest.fr
About this study
Official title: Evaluation du Test " Sofia SARS Antigen FIA Assay " Dans le Cadre du dépistage de la COVID-19
Evaluating the performance of the Sofia SARS Antigen FIA
Read the detailed description
RT-PCR is the reference technique for the diagnosis of COVID-19, as recommended by WHO, ECDC and the HAS College.
Serological tests to identify antibodies developed by the immune system following infection with SARS-CoV-2 are not currently recommended as a first-line test for the initial diagnosis of COVID-19. However, they can be used in cases of negative RT-PCR and suggestive clinical presentation, or as a salvage test when RT-PCR could not be performed within 7 days of symptom onset.
Antigenic tests for the detection of SARS-CoV-2 can be used as a first-line test on nasopharyngeal swabs up to and including 4 days after the onset of symptoms. From the 5th day, only detection by gene amplification is indicated. Given their excellent specificity and the current pandemic situation, it is not necessary to confirm positives with a gene amplification test.
However, it is recommended to perform a gene amplification test when the antigenic test result is negative or uninterpretable in symptomatic patients older than 65 years or with at least one risk factor for severe COVID-19.
For contact persons detected in isolation or in clusters, it is also possible to use antigenic tests in the following cases
- as soon as possible and then at 7 days for high-risk contacts (within the same household as an infected patient) ;
- 7 days after exposure for other contacts (low risk).
Given the rapidity of antigenic test results (15 to 30 minutes), the good performance of the Sofia SARS Antigen FIA test in target populations and its traceability, it could be used as a first-line test in emergency rooms and screening centers and thus have a positive impact on the management of ambulatory patients and, by corollary, on viral transmission.
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV2 Infection, Assessment, EIA, Diagnosis
- Medical subject headings
- COVID-19, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment Vs gold standard
PCR results and Ct values for specimens tested are collected and compared with Sofia results.
Measured: Up to 35 positive PCR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start12 May 2021
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953091
- Sponsor's protocol ID
- ESADEC ( 29BRC21.0117)
- Acronym
- ESADEC
- Status last verified
- Apr 2021
- First submitted
- 6 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du Test " Sofia SARS Antigen FIA Assay " Dans le Cadre du dépistage de la COVID-19
- ClinicalTrials.gov ID
- NCT04953091
- Acronym / sponsor ID
- ESADEC / ESADEC ( 29BRC21.0117)
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV2 Infection, Assessment, EIA, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Jul 2021 (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.
Evaluating the performance of the Sofia SARS Antigen FIA
Detailed description
RT-PCR is the reference technique for the diagnosis of COVID-19, as recommended by WHO, ECDC and the HAS College.
Serological tests to identify antibodies developed by the immune system following infection with SARS-CoV-2 are not currently recommended as a first-line test for the initial diagnosis of COVID-19. However, they can be used in cases of negative RT-PCR and suggestive clinical presentation, or as a salvage test when RT-PCR could not be performed within 7 days of symptom onset.
Antigenic tests for the detection of SARS-CoV-2 can be used as a first-line test on nasopharyngeal swabs up to and including 4 days after the onset of symptoms. From the 5th day, only detection by gene amplification is indicated. Given their excellent specificity and the current pandemic situation, it is not necessary to confirm positives with a gene amplification test.
However, it is recommended to perform a gene amplification test when the antigenic test result is negative or uninterpretable in symptomatic patients older than 65 years or with at least one risk factor for severe COVID-19.
For contact persons detected in isolation or in clusters, it is also possible to use antigenic tests in the following cases
- as soon as possible and then at 7 days for high-risk contacts (within the same household as an infected patient) ;
- 7 days after exposure for other contacts (low risk).
Given the rapidity of antigenic test results (15 to 30 minutes), the good performance of the Sofia SARS Antigen FIA test in target populations and its traceability, it could be used as a first-line test in emergency rooms and screening centers and thus have a positive impact on the management of ambulatory patients and, by corollary, on viral transmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two nasopharyngeal swabs will be taken per included patient. One will be analyzed by RT-PCR in the virology laboratory, the other will be analyzed on site with the Sofia SARS Antigen FIA test. The results of the two tests will then be compared. These samples will not be collected for further research.
Key inclusion criteria (4 listed)
- Adult patient (> or = 18 years of age)
- Patient with symptoms of COVID-19 (Rhinitis, throat pain, nasal congestion or other signs of local manifestation of the disease in the upper respiratory tract, including loss of taste, with or without additional systemic symptoms such as fatigue, fever, muscle pain...) whose health condition does not require hospitalization (mild to moderate disease)
- Patient with these symptoms for 5 days or less with a median of 3 to 4 days.
- Patient with consent to participate in the study
Key exclusion criteria (8 listed)
- Patient with an age below 18 years
- Patient under legal protection (guardianship, curatorship)
- Patient without upper respiratory tract symptoms
- Patients with symptoms for more than 5 days
- Patient with previous COVID-19 diagnosed by RT-PCR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment Vs gold standard
Time frame: Up to 35 positive PCR
PCR results and Ct values for specimens tested are collected and compared with Sofia results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection, run by University Hospital, Brest at 2 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adissa TRAN (02.98.14.50.96, adissa.tran-minoui@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment Vs gold standard (time frame: Up to 35 positive PCR). 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 12 Jul 2021.