Back to resultsPerformance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
Primary Purpose
Covid-19, SARS-CoV-2, Diagnosis
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
samling of oropharynx and nasopharynx
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
- health care workers with symptoms suspicious for Covid-19
Exclusion Criteria:
- none
Sites / Locations
- Jessa Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Health Care Workers with Covid-19 symptoms
Arm Description
3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer
Outcomes
Primary Outcome Measures
sensitivity
sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04361448
Brief Title
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
Official Title
Comparison of the Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient sample number
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.
Detailed Description
Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.
For each volunteer, 3 swabs will be taken:
Flocked eSwab (Copan, Italy) of the oropharynx
Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).
Performance of each method will be calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, SARS-CoV-2, Diagnosis, Polymerase Chain Reaction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Beside the regular sampling method of 1 nasopharyngeal swab, 2 extra swabs will be taken in each volunteer. Performance of the 3 methods for laboratory diagnosis by PCR of Covid-19 will be compared.
Masking
None (Open Label)
Masking Description
Each participant get study number. Samples will be identified by the study number.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Care Workers with Covid-19 symptoms
Arm Type
Other
Arm Description
3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer
Intervention Type
Other
Intervention Name(s)
samling of oropharynx and nasopharynx
Intervention Description
Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs
Primary Outcome Measure Information:
Title
sensitivity
Description
sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
health care workers with symptoms suspicious for Covid-19
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinoud Cartuyvels
Organizational Affiliation
Jessa Hospital, Hasselt, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
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