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

NCT04859023 | Completed

• 2 other identifiers: 21CH0372021-A00390-41
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV Infection

Keywords

Covid19; RT-PCR; rapid antigenic test; SARS-CoV-2; self-sampling; diagnosis; mass screening; isolation measures; health education

Outcome Measures

Primary Outcomes (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).

  Measured by antigenic test results and RT-PCR results.

  Day: 7

Secondary Outcomes (7)

• Number and percentage of SARS-CoV-2 infection in the selected population tested by reference RT-PCR on saliva

  Day: 7

• Number and percentage of the circulation of different variants of interest of SARS-CoV-2 viruses in the tested population

  Day: 7

• Evaluate the acceptability (pain, discomfort, speed of execution) of self-samples according to age and socio-professional categories

  Day: 7

• Evaluate the cost-effectiveness ratio of the new strategy by comparison to the gold standard (RT-PCR on saliva)

  Day: 7

• Number of people who have benefited from sensitization and support specifically set up as part of the screening campaign

  Day: 7

Study Arms (1)

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.

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.

Interventions

saliva sample combined to an anterior nare self-swabbing (Self-samples) DIAGNOSTIC_TEST

Tested by antigenic test.

mass screening SARS-COV-19

saliva sample (Self-sample) DIAGNOSTIC_TEST

Tested by RT-PCR.

mass screening SARS-COV-19

Survey of SARS-COV-19 knowledge OTHER

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.

mass screening SARS-COV-19

Survey of acceptability of the different self-samples. OTHER

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

mass screening SARS-COV-19

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

Related Publications (1)

• 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.

  PMID: 35270262 DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Disease; Health Education

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bruno POZZETTO, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: February 22, 2021
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)