NCT04831853

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	nasopharyngeal swabbing procedure (self swabbing first)	Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
OTHER	nasopharyngeal swabbing procedure (conventionnal swabbing first)	patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: France