Covid-19NCT04361448
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
A study testing samling of oropharynx and nasopharynx in people with Covid-19 and SARS-CoV-2, run by Jessa Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid-19, SARS-CoV-2, Diagnosis
- What is being tested?
- samling of oropharynx and nasopharynx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Apr 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- health care workers with symptoms suspicious for Covid-19
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Covid-19, SARS-CoV-2, Diagnosis, Polymerase Chain Reaction
- Being tested
- samling of oropharynx and nasopharynx
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samling of oropharynx and nasopharynxOther
Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs
| Study group | Role | What they receive |
|---|---|---|
| Health Care Workers with Covid-19 symptoms | Other | 3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer Receives: Other: samling of oropharynx and nasopharynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Insufficient sample number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinoud Cartuyvels, Jessa Hospital
- Investigators
- Reinoud Cartuyvels, Principal investigator, Jessa Hospital, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361448
- Sponsor's protocol ID
- 20.43
- Status last verified
- Feb 2021
- First submitted
- 20 Apr 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04361448
- Acronym / sponsor ID
- 20.43
- Conditions
- Covid-19, SARS-CoV-2, Diagnosis, Polymerase Chain Reaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient sample number
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Care Workers with Covid-19 symptoms | Other | Other: samling of oropharynx and nasopharynx3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- health care workers with symptoms suspicious for Covid-19
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| samling of oropharynx and nasopharynxThree different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs | Other | Health Care Workers with Covid-19 symptoms |
Primary outcome
sensitivity
Time frame: 1 month
sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR
Results and safety
The study was stopped early (reason given: Insufficient sample number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinoud Cartuyvels principal investigator
Jessa Hospital, Hasselt, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing samling of oropharynx and nasopharynx in people with Covid-19 and SARS-CoV-2, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient sample number). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.