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OpenTrials
Completed

NCT Number: NCT04367545

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

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.

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Key information

Conditions

COVID RT-ddPCR Multiplex

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saliva collection

Diagnostic Test

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

Primary outcomes

  1. Number of positive patient using saliva method compared to number of positive patient using standard method

    Time frame: One hour

  2. Number of negative patient using saliva method compared to number of negative patient using standard method

    Time frame: One hour

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: MolCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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