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

May 3, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day: 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Measured by RT-PCR results.
Day: 7
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.
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
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.
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
Measured the screening day.
Day: 7
Number of persons cared for by the territorial isolation support cell (CTAI)
Time Frame: Day: 7
Measured the screening day.
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.
Day: 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Bruno POZZETTO, MD PhD, CHU Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21CH037
  • 2021-A00390-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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