Clinical trial NCT04949074: Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19
Official title: Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Keywords: SARS-CoV-2
saliva
diagnostic
Lead sponsor: ID Solutions
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an indication for SARS-CoV-2 screening

Brief summary: Constitution of a collection of SARS-CoV-2 RNA extracts from nasopharyngeal and saliva / sputum samples, from the same patients (paired samples), taken during the same consultation in an indication of detection of SARS-CoV-2 in with a view to developing tests / diagnostic tools for SARS-CoV-2.

Detailed description: In order to preserve their anonymity, the participant will be identified in a dedicated form by a unique identification number. An identification list of participants will be kept in the investigator's file. The investigator will ensure that the anonymity of each person participating in the research is guaranteed.

The source documents are the original documents, data and files from which the data concerning the participant is reported in the Data set_COLL001.xls form provided to the investigator which will serve as an observation notebook.

The investigator must agree to allow direct access to research source data during monitoring, audit or inspection visits. The source data is for the most part computerized and accessible after authorization.

The data will be transcribed into an Excel form Data set_COLL001.xls pseudonymized form which will serve as an observation book. The data will be recorded and then transmitted to ID SOLUTIONS via the Data set_COLL001.xls form provided to the investigator.

Eligibility criteria: Inclusion Criteria:

* Male, female adult
* Patient with an indication for SARS-CoV-2 screening.
* Patient having been informed and having given his non-objection to participate in the study
* Patient affiliated with a French social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Pregnant or breastfeeding women
* Vulnerable people Adults placed under tutorship or curatorship or under judicial protection, Patient unable to personally give consent, or adult protected by law, Opposition expressed to inclusion in the study.

Primary outcomes:
measure: collection of RNA extracted nasopharyngeal and saliva samples
timeFrame: up to 1 month over which the samples of each participant are collected then tested
measure: collection of RNA extracted nasopharyngeal and saliva samples
timeFrame: up to 1 month over which the samples of each participant are collected then tested
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Bioaxiome
Study officials:
affiliation: Labosud
name: Jeremy M Bayette, Dr
role: PRINCIPAL_INVESTIGATOR
References: