Back to resultsDevelopment of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic (MolCOVID)
Primary Purpose
COVID, RT-ddPCR Multiplex
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saliva collection
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID
Eligibility Criteria
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
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with COVID-19 infection suspicion
Arm Description
Patient with COVID-19 infection suspicion are tested using standard diagnosis method
Outcomes
Primary Outcome Measures
Number of positive patient using saliva method compared to number of positive patient using standard method
Number of negative patient using saliva method compared to number of negative patient using standard method
Secondary Outcome Measures
Full Information
NCT ID
NCT04367545
First Posted
April 27, 2020
Last Updated
November 4, 2020
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04367545
Brief Title
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Acronym
MolCOVID
Official Title
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
May 17, 2020 (Actual)
Study Completion Date
May 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, RT-ddPCR Multiplex
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with COVID-19 infection suspicion
Arm Type
Experimental
Arm Description
Patient with COVID-19 infection suspicion are tested using standard diagnosis method
Intervention Type
Diagnostic Test
Intervention Name(s)
Saliva collection
Intervention Description
Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)
Primary Outcome Measure Information:
Title
Number of positive patient using saliva method compared to number of positive patient using standard method
Time Frame
One hour
Title
Number of negative patient using saliva method compared to number of negative patient using standard method
Time Frame
One hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry FREBOURG, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
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