SARS-CoV InfectionAutoCoVNCT04859023

Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection (COVID-19).

A study testing saliva sample combined to an anterior nare self-swabbing (Self-samples), saliva sample (Self-sample) and Survey of SARS-COV-19 knowledge in people with SARS-CoV Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for: SARS-CoV Infection
What is being tested?: saliva sample combined to an anterior nare self-swabbing (Self-samples), saliva sample (Self-sample) and Survey of SARS-COV-19 knowledge
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10,000 participants
Where: 1 siteFrance
Study dates: 22 Feb 2021to 28 Feb 2021
Phase: Interventional
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 10 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research

Who cannot join

Inability to understand the protocol (language barrier notably)
Deny to participate to the proposed research
Patients under tutorship

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Saint-Etienne
Saint-Etienne

Other trials in France

About this study

Official title: Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).

The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.

Read the detailed description

The main objective is to evaluate the performance of a strategy for screening for CoV-2-SARS infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary RT-PCR technique recently validated by National Authority for Health (HAS).

Conditions: SARS-CoV Infection
Being tested: saliva sample combined to an anterior nare self-swabbing (Self-samples), saliva sample (Self-sample), Survey of SARS-COV-19 knowledge, Survey of acceptability of the different self-samples.
Keywords: Covid19, RT-PCR, rapid antigenic test, SARS-CoV-2, self-sampling, diagnosis, mass screening, isolation measures, health education
Medical subject headings: Severe Acute Respiratory Syndrome, COVID-19, Disease, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

saliva sample combined to an anterior nare self-swabbing (Self-samples)Diagnostic test
Tested by antigenic test.
saliva sample (Self-sample)Diagnostic test
Tested by RT-PCR.
Survey of SARS-COV-19 knowledgeOther
collection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.
Survey of acceptability of the different self-samples.Other
collection of : assessment and acceptability of the tolerance of self-samples.

Study groups in NCT04859023
Study group	Role	What they receive
mass screening SARS-COV-19	Experimental	20 0000 participant will be included during mass screening SARS-COV-19 of the population of the city of Saint-Etienne. They will have two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. Receives: Diagnostic Test: saliva sample combined to an anterior nare self-swabbing (Self-samples); Diagnostic Test: saliva sample (Self-sample); Other: Survey of SARS-COV-19 knowledge; Other: Survey of acceptability of the different self-samples.

What is being measured

The primary outcome is the main question the study is designed to answer.

Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).
Measured by antigenic test results and RT-PCR results.
Measured: Day: 7

Secondary outcomes (7)

Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva
Measured by RT-PCR results.
Measured: Day: 7
Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population
Measured by RT-PCR results.
Measured: Day: 7
Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories
Measured by survey of acceptability of the different self-samples results.
Measured: Day: 7
Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)
Measured by number of test performed and performances of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR.
Measured: Day: 7
Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign
Measured the screening day.
Measured: Day: 7
Number of persons cared for by the territorial isolation support cell (CTAI)
Measured the screening day.
Measured: Day: 7
Health literacy questionnaire
It is a questionnaire with items on the transmission of the virus and barrier gestures, adherence to barrier gestures, modalities of isolation in case of positivity and motivations for participating in this screening campaign.
Measured: Day: 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202128 Feb 2021

First posted26 Apr 2021
Study start22 Feb 2021
Primary completion28 Feb 2021
Study completion28 Feb 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 SARS-CoV InfectionStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04859023
Sponsor's protocol ID: 21CH037
Other IDs: 2021-A00390-41
Acronym: AutoCoV
Status last verified: May 2021
First submitted: 22 Apr 2021
Last updated: 6 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Verot E, Bonjean P, Chaux R, Gagnaire J, Gagneux-Brunon A, Pozzetto B, Berthelot P, Botelho-Nevers E, Chauvin F. Development and Validation of the COVID-19 Knowledges and Behavior Questionnaire in a French Population (CoVQuest-CC). Int J Environ Res Public Health. 2022 Feb 23;19(5):2569. doi: 10.3390/ijerph19052569.
PubMed 35270262

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All SARS-CoV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).
ClinicalTrials.gov ID: NCT04859023
Acronym / sponsor ID: AutoCoV / 21CH037
Conditions: SARS-CoV Infection
Keywords: Covid19, RT-PCR, rapid antigenic test, SARS-CoV-2, self-sampling, diagnosis, mass screening, isolation measures
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,000 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Study start: 22 Feb 2021 (actual)
Primary completion: 28 Feb 2021 (actual)
Study completion: 28 Feb 2021 (actual)
First posted: 26 Apr 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
mass screening SARS-COV-19	Experimental	Diagnostic Test: saliva sample combined to an anterior nare self-swabbing (Self-samples), Diagnostic Test: saliva sample (Self-sample), Other: Survey of SARS-COV-19 knowledge, Other: Survey of acceptability of the different self-samples.20 0000 participant will be included during mass screening SARS-COV-19 of the population of the city of Saint-Etienne. They will have two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research

Key exclusion criteria (3 listed)

Inability to understand the protocol (language barrier notably)
Deny to participate to the proposed research
Patients under tutorship

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
saliva sample combined to an anterior nare self-swabbing (Self-samples)Tested by antigenic test.	Diagnostic test	mass screening SARS-COV-19
saliva sample (Self-sample)Tested by RT-PCR.	Diagnostic test	mass screening SARS-COV-19
Survey of SARS-COV-19 knowledgecollection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.	Other	mass screening SARS-COV-19
Survey of acceptability of the different self-samples.collection of : assessment and acceptability of the tolerance of self-samples.	Other	mass screening SARS-COV-19

Primary outcome

Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard).
Time frame: Day: 7
Measured by antigenic test results and RT-PCR results.

7 secondary outcomes

Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva
Time frame: Day: 7
Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population
Time frame: Day: 7
Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories
Time frame: Day: 7
Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)
Time frame: Day: 7
Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign
Time frame: Day: 7
Number of persons cared for by the territorial isolation support cell (CTAI)
Time frame: Day: 7
Health literacy questionnaire
Time frame: Day: 7

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 6 May 2021.
Derived from this study: PubMed 35270262Verot E, Bonjean P, Chaux R, Gagnaire J, Gagneux-Brunon A, Pozzetto B, Berthelot P, Botelho-Nevers E, Chauvin F. Development and Validation of the COVID-19 Knowledges and Behavior Questionnaire in a French Population (CoVQuest-CC). Int J Environ Res Public Health. 2022 Feb 23;19(5):2569. doi: 10.3390/ijerph19052569.
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.

Bruno POZZETTO, MD PhD principal investigator

Centre Hospitalier Universitaire de Saint Etienne

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 6 May 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?

Positivity of self-samples combining saliva and anterior nare specimens tested by rapid antigenic test compared to saliva tested by RT-PCR (gold-standard). (time frame: Day: 7). 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 NCT04859023, 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 6 May 2021.