Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831853
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2021-04-01
Brief Title:
Self- Versus Conventional-swabbing for COVID-19 Screening COVISWAB
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVISWAB
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A02913-36 | OTHER | ANSM | None |