Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715607
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2021-01-12
Brief Title:
COVID-19 SARS-CoV-2 Detection in Saliva Oropharyngeal and Nasopharyngeal Specimens
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Comparison of Detection Rate of SARS-CoV-2 in Saliva Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva oropharyngeal swabs or nasopharyngeal swab method for specimen collection
Detailed Description:
The reference test to evaluate patients with suspected respiratory infection caused by virus is a real-time reverse transcription-polymerase chain reaction RT-PCR from a nasopharyngeal swab NPS However other specimen collection methods like oropharyngeal swabs OPS and a saliva specimen collection have also been accepted by the Centers for Disease Control and Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 COVID-19 pandemic It is unclear how much the SARS-CoV-2 detection rate differs when using different sampling methods and the aim of this study is to compare the expected COVID-19 detection rate using saliva oropharyngeal swabs or nasopharyngeal swab in a public setting
We therefore aim to investigate the detection rate of SARS-CoV-2 in Saliva oropharyngeal swab and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic
Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study They will have saliva OPS and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2 The rate for SARS-CoV-2 detection in saliva OPS and NPS will be compared using a logistic regression mixed-effect analysis A Sample Size Calculation estimated that a sample of 18000 participants would be needed for the trial with 80 power at a significance level of 5
We therefore aim to investigate the detection rate of SARS-CoV-2 in Saliva oropharyngeal swab and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic
Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study They will have saliva OPS and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2 The rate for SARS-CoV-2 detection in saliva OPS and NPS will be compared using a logistic regression mixed-effect analysis A Sample Size Calculation estimated that a sample of 18000 participants would be needed for the trial with 80 power at a significance level of 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None