Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Other: saliva sampling

• Registration Number: NCT04949074
• Lead Sponsor: ID Solutions

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.

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Study Start: 2021-08-01
• Status Verified: 2022-04
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RNA extracted from Positive saliva samples	saliva sampling	RNA extracted from saliva samples found positive for the presence of SARS-CoV-2
RNA extracted from negative saliva samples	saliva sampling	RNA extracted from saliva samples found negative for the presence of SARS-CoV-2

Primary Outcome Measures

Name	Time	Method
collection of RNA extracted nasopharyngeal and saliva samples	up to 1 month over which the samples of each participant are collected then tested	Collection of; n=130 positive n=130 negative; RNA extracted from both nasopharyngeal and saliva samples from same patients sampled at the same time with suspicious COVID-19 will enter the collection

Trial Locations

Locations (1)

Bioaxiome; 🇫🇷 Nîmes, France