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COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR

NCT ID: NCT04599959

Last Updated: 2021-07-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-26

Study Completion Date

2021-01-20

Brief Summary

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The main objective of the tests is to establish saliva collection with Salivette® Cortisol.

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Detailed Description

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Conditions

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Covid-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Overall (Swab/Saliva)

Group Type EXPERIMENTAL

Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

Intervention Type DIAGNOSTIC_TEST

Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit

Interventions

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Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Informed consent form signed and dated before any samples have been taken.
2. Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
3. Male and/or female patients aged 18 years and over.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

México, , Mexico

Site Status

Countries

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Mexico

References

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Moroni-Zentgraf P, Keller C, Eschenfelder CC, Walter Muller H, Sigmund R, Galeana-Cadena D, Marquez-Garcia JE, Moncada-Morales A, Zuniga JA. Salivette(R) Cortisol versus oropharyngeal swabbing for the detection of SARS-CoV-2 infection. Expert Rev Mol Diagn. 2023 Jul-Dec;23(11):1011-1014. doi: 10.1080/14737159.2023.2260308. Epub 2023 Oct 24.

Reference Type DERIVED
PMID: 37724431 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mystudywindow.com

Click here to connect to Boehringer Ingelheim Clinical Studies Website

Other Identifiers

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0352-2150

Identifier Type: -

Identifier Source: org_study_id

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