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

NCT04949074 | Completed

• 1 other identifier: 2021-A00877-34
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

SARS-CoV-2; saliva; diagnostic

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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

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

Interventions

saliva sampling OTHER

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 Positive saliva samples; RNA extracted from negative saliva samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an indication for SARS-CoV-2 screening

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women

Sponsors & Collaborators

• ID Solutions: lead

Study Sites (1)

Bioaxiome

Nîmes, 30900, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA extracted from nasopharyngeal and saliva / sputum extracts from the same patients

MeSH Terms

Conditions

Respiratory Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeremy M Bayette, Dr

  Labosud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 2, 2021
• Study Start: August 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 9, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)