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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04367545
Acronym
MolCOVID
Enrollment
130
Registered
2020-04-29
Start date
2020-04-16
Completion date
2020-05-17
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, RT-ddPCR Multiplex

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. 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.

Interventions

DIAGNOSTIC_TESTSaliva collection

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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of positive patient using saliva method compared to number of positive patient using standard methodOne hour
Number of negative patient using saliva method compared to number of negative patient using standard methodOne hour

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThierry FREBOURG, Pr

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026