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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT04367545

Collaborator

(none)

130

Enrollment

Location

Arm

Actual Duration (Months)

127.6

Patients Per Site Per Month

Study Details

Study Description

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 :

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

Condition or Disease	Intervention/Treatment	Phase
COVID RT-ddPCR Multiplex	Diagnostic Test: Saliva collection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 16, 2020

Actual Primary Completion Date :

May 17, 2020

Actual Study Completion Date :

May 17, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: Thierry FREBOURG, Pr, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT04367545

Other Study ID Numbers:

2020/0094/OB

First Posted:

Apr 29, 2020

Last Update Posted:

Nov 5, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 5, 2020