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

Not Applicable

Completed

• Conditions: Covid-19
• Interventions: Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

• Registration Number: NCT04599959
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Study Start: 2020-10-26
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Status Verified: 2021-07
• Results First Submitted: 2021-07-21
• Results First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Results First Posted: 2021-07-26
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall (Swab/Saliva)	Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico	At baseline (the test day), up to one day.	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.
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany	At baseline (the test day), up to one day.	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".

Trial Locations

Locations (1)

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas; 🇲🇽 Mexico, Mexico