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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Other: nasopharyngeal swabbing procedure (self swabbing first); Other: nasopharyngeal swabbing procedure (conventionnal swabbing first)

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised self-swabbing followed by conventional swabbing; 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); Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
Experimental: Conventional swabbing followed by supervised self-swabbing; the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first.	Other: nasopharyngeal swabbing procedure (conventionnal swabbing first); patient undergoes conventionnal swabbing first then realises the nasal swabbing himself

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Richness assessment for respiratory cells	Ct value of beta-globin gene	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	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	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).	5 minutes after the end of the procedure of nasopharyngeal swabbing

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Xavier MOISSET, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; pain; COVID-19; Sensitivity; Nasopharyngeal swabbing; Self-swabbing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RBHP 2020 MOISSET 2; 2020-A02913-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No