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

I

ID Solutions

Status

Completed

Conditions

Respiratory Tract Infections

Treatments

Other: saliva sampling

Study type

Observational

Funder types

Industry

Identifiers

NCT04949074
2021-A00877-34

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 4 patient groups

RNA extracted from Positive NSP samples
Description:
RNA extracted from NSP samples, found positive for the presence of SARS-CoV-2
RNA extracted from Positive saliva samples
Description:
RNA extracted from saliva samples found positive for the presence of SARS-CoV-2
Treatment:
Other: saliva sampling
RNA extracted from negative NSP samples
Description:
RNA extracted from NSP samples, found negative for the presence of SARS-CoV-2
RNA extracted from negative saliva samples
Description:
RNA extracted from saliva samples found negative for the presence of SARS-CoV-2
Treatment:
Other: saliva sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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