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NCT04361448 Clinical Trial

Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04361448
Other study ID # 20.43
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 20, 2020
Est. completion date June 30, 2020

Study information
Verified date February 2021
Source Jessa Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - health care workers with symptoms suspicious for Covid-19 Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• samling of oropharynx and nasopharynx
Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs

Locations
Country Name City State
Belgium Jessa Hospital Hasselt

Sponsors (1)
Lead Sponsor Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR 1 month
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