Clinical trial NCT04352959: COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
Official title: COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID19
Mouthwash
Saliva
Keywords: covid19
SARS-CoV-2
mouthrinses
antiviral
bêta-cyclodextrin
citrox
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2020-04-20
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor
* Clinical signs started less than 8 days ago.
* Virological confirmation
* Understanding and acceptance of the trial.
* Written agreement to participate in the trial

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Inability to comply with protocol
* Lack of written agreement

Primary outcomes:
measure: Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days
timeFrame: 7 days
Secondary outcomes:
measure: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Caluire-et-Cuire
country: France
facility: Clinic of the Protestant Infirmary in Lyon
city: Le Puy en Velay
country: France
facility: Hospital Center Emile Roux
city: Lyon
country: France
facility: Hospital Center Saint Luc Saint Joseph
city: Mont de Marsan
country: France
facility: Intercommunal Hospital Center of Mont de Marsan
Study officials:
affiliation: University Claude Bernard Lyon 1
name: Florence Carrouel, Dr
role: STUDY_DIRECTOR
References:
citation: Carrouel F, Conte MP, Fisher J, Goncalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with beta-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4):1126. doi: 10.3390/jcm9041126.
citation: Carrouel F, Goncalves LS, Conte MP, Campus G, Fisher J, Fraticelli L, Gadea-Deschamps E, Ottolenghi L, Bourgeois D. Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2. J Dent Res. 2021 Feb;100(2):124-132. doi: 10.1177/0022034520967933. Epub 2020 Oct 22.
citation: Carrouel F, Viennot S, Valette M, Cohen JM, Dussart C, Bourgeois D. Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 2;21(1):906. doi: 10.1186/s13063-020-04846-6.
citation: Burton MJ, Clarkson JE, Goulao B, Glenny AM, McBain AJ, Schilder AG, Webster KE, Worthington HV. Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them. Cochrane Database Syst Rev. 2020 Sep 16;9(9):CD013627. doi: 10.1002/14651858.CD013627.pub2.