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

COVID Clinical Trial

— MolCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367545
• Other study ID #: 2020/0094/OB
• Status: Completed
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: May 17, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 17, 2020
• Est. primary completion date: May 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• RT-ddPCR Multiplex

Intervention

Diagnostic Test:
• Saliva collection
Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of positive patient using saliva method compared to number of positive patient using standard method		One hour
Primary	Number of negative patient using saliva method compared to number of negative patient using standard method		One hour