Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB)

Covid19 Clinical Trial

— COVISWAB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04831853
• Other study ID #: RBHP 2020 MOISSET 2
• Secondary ID: 2020-A02913-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
• Fluent in French (both oral and written)
• Able to give an eclaired consent

Exclusion Criteria:

• Contra-indication to nasopharyngeal swabbing
• Refusal to participate
• Pregnant women

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• nasopharyngeal swabbing procedure (self swabbing first)
Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
• nasopharyngeal swabbing procedure (conventionnal swabbing first)
patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes after the end of the procedure of nasopharyngeal swabbing
Secondary	Correlation between age, sex and swabbing-induced pain	Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	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)	5 minutes after the end of the procedure
Secondary	Richness assessment for respiratory cells	Ct value of beta-globin gene	Day 0
Secondary	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	5 minutes after the end of the procedure of nasopharyngeal swabbing
Secondary	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	5 minutes after the end of the procedure of nasopharyngeal swabbing
Secondary	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).	5 minutes after the end of the procedure of nasopharyngeal swabbing