Covid19COVISWABNCT04831853
Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB)
A study testing nasopharyngeal swabbing procedure (self swabbing first) and nasopharyngeal swabbing procedure (conventionnal swabbing first) in people with Covid19, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available. In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- nasopharyngeal swabbing procedure (self swabbing first) and nasopharyngeal swabbing procedure (conventionnal swabbing first)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2021to Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
- Fluent in French (both oral and written)
- Able to give an eclaired consent
Who cannot join
- Contra-indication to nasopharyngeal swabbing
- Refusal to participate
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Xavier Moisset
About this study
Official title: Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study
Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.
In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.
The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.
Read the detailed description
All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.
All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.
- Conditions
- Covid19
- Being tested
- nasopharyngeal swabbing procedure (self swabbing first), nasopharyngeal swabbing procedure (conventionnal swabbing first)
- Keywords
- SARS-CoV-2, COVID-19, Nasopharyngeal swabbing, Self-swabbing, pain, Sensitivity
- Medical subject headings
- COVID-19, Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swabbing procedure (self swabbing first)Other
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
nasopharyngeal swabbing procedure (conventionnal swabbing first)Other
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
| Study group | Role | What they receive |
|---|---|---|
| Supervised self-swabbing followed by conventional swabbing | Experimental | the subjects will first benefit from a 5 minutes explanation on how to perform self-swabbing and will then performed the swabbing under the supervision of a trained healthcare professional Receives: Other: nasopharyngeal swabbing procedure (self swabbing first) |
| Conventional swabbing followed by supervised self-swabbing | Experimental | the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first. Receives: Other: nasopharyngeal swabbing procedure (conventionnal swabbing first) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing). If non-inferiority is confirmed on this criterion, pain will be tested.
Measured: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Secondary outcomes (11)
Correlation between age, sex and swabbing-induced pain
Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced pain
Eye-color self-reported by the subject on a validated 14 item scale and pain score on the numeric rating scale (NRS) (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced discomfort
Eye-color self-reported by the subject on a validated 14 item scale and discomfort score on numeric rating scale (0 to 10; higher scores meaning more discomfort)
Measured: 5 minutes after the end of the procedure
Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Correlation between body mass index and swabbing-induced pain
symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Correlation between anticipated pain and actual pain
anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Correlation between anticipated discomfort and actual discomfort.
anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain)
Measured: 5 minutes after the end of the procedure
Richness assessment for respiratory cells
Ct value of beta-globin gene
Measured: Day 0
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
assessed using a Numerical Rating Scale (0 indicating no pain and 10 the worst imaginable pain). If non-inferiority is confirmed on this criterion, discomfort will be tested
Measured: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
assessed using a Numerical Rating Scale (0 indicating no discomfort and 10 the worst imaginable discomfort). If non-inferiority is confirmed on this criterion, acceptability will be tested
Measured: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
assessed using a Numerical Rating Scale (0 indicating that the procedure is not acceptable at all and 10 that the procedure is perfectly well accepted).
Measured: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MOISSET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831853
- Sponsor's protocol ID
- RBHP 2020 MOISSET 2
- Other IDs
- 2020-A02913-36
- Acronym
- COVISWAB
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04831853
- Acronym / sponsor ID
- COVISWAB / RBHP 2020 MOISSET 2
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, COVID-19, Nasopharyngeal swabbing, Self-swabbing, pain, Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Apr 2021 (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.
Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.
In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.
The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.
Detailed description
All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.
All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
| Arm | Type | Receives |
|---|---|---|
| Supervised self-swabbing followed by conventional swabbing | Experimental | Other: nasopharyngeal swabbing procedure (self swabbing first)the subjects will first benefit from a 5 minutes explanation on how to perform self-swabbing and will then performed the swabbing under the supervision of a trained healthcare professional |
| Conventional swabbing followed by supervised self-swabbing | Experimental | Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
- Fluent in French (both oral and written)
- Able to give an eclaired consent
Key exclusion criteria (3 listed)
- Contra-indication to nasopharyngeal swabbing
- Refusal to participate
- Pregnant women
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 |
|---|---|---|
| nasopharyngeal swabbing procedure (self swabbing first)Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing | Other | Supervised self-swabbing followed by conventional swabbing |
| nasopharyngeal swabbing procedure (conventionnal swabbing first)patient undergoes conventionnal swabbing first then realises the nasal swabbing himself | Other | Conventional swabbing followed by supervised self-swabbing |
Primary outcome
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing). If non-inferiority is confirmed on this criterion, pain will be tested.
11 secondary outcomes
Correlation between age, sex and swabbing-induced pain
Time frame: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced pain
Time frame: 5 minutes after the end of the procedure
Correlation between eye color and swabbing-induced discomfort
Time frame: 5 minutes after the end of the procedure
Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain
Time frame: 5 minutes after the end of the procedure
Correlation between body mass index and swabbing-induced pain
Time frame: 5 minutes after the end of the procedure
Correlation between anticipated pain and actual pain
Time frame: 5 minutes after the end of the procedure
Correlation between anticipated discomfort and actual discomfort.
Time frame: 5 minutes after the end of the procedure
Richness assessment for respiratory cells
Time frame: Day 0
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability
Time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
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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.
Xavier MOISSET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal swabbing procedure (self swabbing first) and nasopharyngeal swabbing procedure (conventionnal swabbing first) in people with Covid19, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity (time frame: 5 minutes after the end of the procedure of nasopharyngeal swabbing). 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 5 Apr 2021.