NCT04831853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

April 1, 2021

Last Update Submit

April 2, 2021

Conditions

Covid19

Keywords

SARS-CoV-2COVID-19Nasopharyngeal swabbingSelf-swabbingpainSensitivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Correlation between age, sex and swabbing-induced pain

    5 minutes after the end of the procedure

  • Correlation between eye color and swabbing-induced pain

    5 minutes after the end of the procedure

  • Correlation between eye color and swabbing-induced discomfort

    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

    5 minutes after the end of the procedure

  • Correlation between body mass index and swabbing-induced pain

    5 minutes after the end of the procedure

  • +6 more secondary outcomes

Study Arms (2)

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

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.

Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)

Interventions

nasopharyngeal swabbing procedure (self swabbing first)OTHER

Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing

Supervised self-swabbing followed by conventional swabbing
nasopharyngeal swabbing procedure (conventionnal swabbing first)OTHER

patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

Conventional swabbing followed by supervised self-swabbing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

COVID-19PainHypersensitivity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Xavier MOISSET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

April 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

April 5, 2021

Record last verified: 2021-03

Locations

FR(1)