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

Covid-19 Clinical Trial

Official title:

COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599959
• Other study ID #: 0352-2150
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: July 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico	Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.	At baseline (the test day), up to one day.
Primary	Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany	Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".	At baseline (the test day), up to one day.

External Links

•   Click here to connect to Boehringer Ingelheim Clinical Studies Website