COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses

NCT ID: NCT04352959

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2020-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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COVID19 Mouthwash Saliva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mouth rinse with antiviral

Group Type ACTIVE_COMPARATOR

mouthrinse with bêta-cyclodextrin and citrox

Intervention Type DEVICE

3 daily mouthrinses for 7 days

mouth rinse without antiviral

Group Type PLACEBO_COMPARATOR

mouthrinse without bêta-cyclodextrin and citrox

Intervention Type DEVICE

3 daily mouthrinses for 7 days

Interventions

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mouthrinse with bêta-cyclodextrin and citrox

3 daily mouthrinses for 7 days

Intervention Type DEVICE

mouthrinse without bêta-cyclodextrin and citrox

3 daily mouthrinses for 7 days

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Claude Bernard University

OTHER

Sponsor Role lead

Responsible Party

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Carrouel Florence

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florence Carrouel, Dr

Role: STUDY_DIRECTOR

University Claude Bernard Lyon 1

Locations

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Clinic of the Protestant Infirmary in Lyon

Caluire-et-Cuire, , France

Site Status

Hospital Center Emile Roux

Le Puy-en-Velay, , France

Site Status

Hospital Center Saint Luc Saint Joseph

Lyon, , France

Site Status

Intercommunal Hospital Center of Mont de Marsan

Mont-de-Marsan, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32326426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33089717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33138848 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32936948 (View on PubMed)

Other Identifiers

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BBCovid

Identifier Type: -

Identifier Source: org_study_id

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