Clinical trial NCT04859023: Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection (COVID-19).
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV Infection
Keywords: Covid19
RT-PCR
rapid antigenic test
SARS-CoV-2
self-sampling
diagnosis
mass screening
isolation measures
health education
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility 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

Primary outcomes:
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).
timeFrame: Day: 7
Secondary outcomes:
measure: Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva
timeFrame: Day: 7
measure: Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population
timeFrame: Day: 7
measure: Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories
timeFrame: Day: 7
measure: Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)
timeFrame: Day: 7
measure: Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign
timeFrame: Day: 7
measure: Number of persons cared for by the territorial isolation support cell (CTAI)
timeFrame: Day: 7
measure: Health literacy questionnaire
timeFrame: Day: 7
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bruno POZZETTO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.