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

Respiratory Tract Infections Clinical Trial

— COLL001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949074
• Other study ID #: 2021-A00877-34
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2022
• Source: ID Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	Bioaxiome	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
ID Solutions

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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