Back to resultsCOVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
Primary Purpose
Covid-19
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
- Informed consent form signed and dated before any samples have been taken.
- Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
- Male and/or female patients aged 18 years and over.
Sites / Locations
- Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Overall (Swab/Saliva)
Arm Description
Outcomes
Primary Outcome Measures
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.
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".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04599959
Brief Title
COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the tests is to establish saliva collection with Salivette® Cortisol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Overall (Swab/Saliva)
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Intervention Description
Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit
Primary Outcome Measure Information:
Title
Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
Description
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.
Time Frame
At baseline (the test day), up to one day.
Title
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany
Description
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".
Time Frame
At baseline (the test day), up to one day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent form signed and dated before any samples have been taken.
Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
Male and/or female patients aged 18 years and over.
Facility Information:
Facility Name
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: http://trials.boehringer-ingelheim.com/
Links:
URL
http://www.mystudywindow.com
Description
Click here to connect to Boehringer Ingelheim Clinical Studies Website
Learn more about this trial
COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
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