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

April 13, 2026 updated by: University Hospital, Rouen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

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
      • Rouen, France
        • Rouen University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with COVID-19 infection suspicion
Patient with COVID-19 infection suspicion are tested using standard diagnosis method
Diagnostic test: Saliva collection
Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of positive patient using saliva method compared to number of positive patient using standard method
Time Frame: One hour
One hour
Number of negative patient using saliva method compared to number of negative patient using standard method
Time Frame: One hour
One hour

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Thierry FREBOURG, Pr, University Hospital, Rouen

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)

April 16, 2020

Primary Completion (Actual)

May 17, 2020

Study Completion (Actual)

May 17, 2020

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/0094/OB

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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