Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic

NCT04367545 | Completed

• 1 other identifier: 2020/0094/OB
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :

1. 1.to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. 2.to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. 3.and to have a method compatible with screening extended to populations at risk.

Conditions

COVID; RT-ddPCR Multiplex

Outcome Measures

Primary Outcomes (2)

• Number of positive patient using saliva method compared to number of positive patient using standard method

  One hour

• Number of negative patient using saliva method compared to number of negative patient using standard method

  One hour

Study Arms (1)

Patient with COVID-19 infection suspicion

EXPERIMENTAL

Patient with COVID-19 infection suspicion are tested using standard diagnosis method

Diagnostic Test: Saliva collection

Interventions

Saliva collection DIAGNOSTIC_TEST

Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)

Patient with COVID-19 infection suspicion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
• Person affiliated to a social security scheme

You may not qualify if:

• Person objecting to participation in the research after reading information
• Person under the protection of justice,
• Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

• Cassinari K, Alessandri-Gradt E, Chambon P, Charbonnier F, Gracias S, Beaussire L, Alexandre K, Sarafan-Vasseur N, Houdayer C, Etienne M, Caron F, Plantier JC, Frebourg T. Assessment of Multiplex Digital Droplet RT-PCR as a Diagnostic Tool for SARS-CoV-2 Detection in Nasopharyngeal Swabs and Saliva Samples. Clin Chem. 2021 Apr 29;67(5):736-741. doi: 10.1093/clinchem/hvaa323.

  PMID: 33331864 RESULT

Study Officials

• Thierry FREBOURG, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 16, 2020
• Primary Completion: May 17, 2020
• Study Completion: May 17, 2020
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)