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

NCT ID: NCT04949074

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-15

Brief Summary

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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

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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.

Conditions

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Respiratory Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RNA extracted from Positive NSP samples

RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2

No interventions assigned to this group

RNA extracted from Positive saliva samples

RNA extracted from saliva samples found positive for the presence of SARS-CoV-2

saliva sampling

Intervention Type 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 negative NSP samples

RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2

No interventions assigned to this group

RNA extracted from negative saliva samples

RNA extracted from saliva samples found negative for the presence of SARS-CoV-2

saliva sampling

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ID Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy M Bayette, Dr

Role: PRINCIPAL_INVESTIGATOR

Labosud

Locations

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Bioaxiome

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00877-34

Identifier Type: -

Identifier Source: org_study_id

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