Collection of RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients With Suspicion of Covid-19 (COLL001)

Collection of SARS-CoV-2 RNA Extracted From Nasopharyngeal and Saliva Samples From Same Patients

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Other: saliva sampling

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 Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30900
    • Bioaxiome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an indication for SARS-CoV-2 screening

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RNA extracted from Positive NSP samples; RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2
RNA extracted from Positive saliva samples; RNA extracted from saliva samples found positive for the presence of SARS-CoV-2	Other: saliva sampling; when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked
RNA extracted from negative NSP samples; RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2
RNA extracted from negative saliva samples; RNA extracted from saliva samples found negative for the presence of SARS-CoV-2	Other: saliva sampling; when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
collection of RNA extracted nasopharyngeal and saliva samples	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	up to 1 month over which the samples of each participant are collected then tested
collection of RNA extracted nasopharyngeal and saliva samples	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	up to 1 month over which the samples of each participant are collected then tested

Collaborators and Investigators

• Sponsor: ID Solutions
• Investigators: Principal Investigator: Jeremy M Bayette, Dr, Labosud

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; diagnostic; saliva
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2021-A00877-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data will not be shared to other researchers since the research is an internal collection of samples; for ID SOLUTIONS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No