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TerminatedNCT04361448Updated Feb 15, 2021

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

An interventional study of samling of oropharynx and nasopharynx in Covid-19, SARS-CoV-2 and Diagnosis, sponsored by Jessa Hospital. Terminated at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2021-02-15.

Sponsored by Jessa Hospital · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Insufficient sample number
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid-19
  • SARS-CoV-2
  • Diagnosis
  • Polymerase Chain Reaction

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Jessa Hospital is the lead sponsor of 85 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • health care workers with symptoms suspicious for Covid-19

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Health Care Workers with Covid-19 symptoms

    3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer

    Other: samling of oropharynx and nasopharynx

Interventions

  • Othersamling of oropharynx and nasopharynx

    Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs

06

What researchers measure

Primary outcomes

  1. sensitivity

    sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR

    Time frame: 1 month

07

Study locations

1 site
  • Jessa Hospital
    Hasselt, 3500, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04361448
Lead sponsor
Jessa Hospital
Responsible party
Reinoud Cartuyvels (MD, Jessa Hospital) — Principal investigator
First posted
Apr 24, 2020
Start date
Apr 20, 2020
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Feb 15, 2021

Study contacts

Reinoud Cartuyvels
principal investigator · Jessa Hospital, Hasselt, Belgium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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