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

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ClinicalTrials.gov Identifier: NCT04859023
Recruitment Status : Completed
First Posted : April 26, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection 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. Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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).
Actual Study Start Date : February 22, 2021
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mass screening SARS-COV-19

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.

 Diagnostic Test: saliva sample combined to an anterior nare self-swabbing (Self-samples)
Tested by antigenic test.

Diagnostic Test: saliva sample (Self-sample)
Tested by RT-PCR.

Other: Survey of SARS-COV-19 knowledge
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.

Other: Survey of acceptability of the different self-samples.
collection of : assessment and acceptability of the tolerance of self-samples.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva [ Time Frame: Day: 7 ]
    Measured by RT-PCR results.

  2. Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population [ Time Frame: Day: 7 ]
    Measured by RT-PCR results.

  3. Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories [ Time Frame: Day: 7 ]
    Measured by survey of acceptability of the different self-samples results.

  4. Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva) [ Time Frame: Day: 7 ]
    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.

  5. Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign [ Time Frame: Day: 7 ]
    Measured the screening day.

  6. Number of persons cared for by the territorial isolation support cell (CTAI) [ Time Frame: Day: 7 ]
    Measured the screening day.

  7. Health literacy questionnaire [ Time Frame: Day: 7 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to understand the protocol (language barrier notably)
  • Deny to participate to the proposed research
  • Patients under tutorship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859023


Locations
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France
CHU Saint-Etienne
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Bruno POZZETTO, MD PhD CHU Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04859023    
Other Study ID Numbers: 21CH037
2021-A00390-41 ( Other Identifier: ANSM )
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Covid19
RT-PCR
rapid antigenic test
SARS-CoV-2
self-sampling
 diagnosis
mass screening
isolation measures
health education
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Severe Acute Respiratory Syndrome
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases