NCT04352959

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

4 active sites

Status
completed

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 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

April 15, 2020

Last Update Submit

February 10, 2021

Conditions

COVID19MouthwashSaliva

Keywords

covid19SARS-CoV-2mouthrinsesantiviralbêta-cyclodextrincitrox

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days

    Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made

    7 days

Secondary Outcomes (1)

  • Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days

    7 days

Study Arms (2)

mouth rinse with antiviral

ACTIVE COMPARATOR
Device: mouthrinse with bêta-cyclodextrin and citrox

mouth rinse without antiviral

PLACEBO COMPARATOR
Device: mouthrinse without bêta-cyclodextrin and citrox

Interventions

mouthrinse with bêta-cyclodextrin and citroxDEVICE

3 daily mouthrinses for 7 days

mouth rinse with antiviral
mouthrinse without bêta-cyclodextrin and citroxDEVICE

3 daily mouthrinses for 7 days

mouth rinse without antiviral

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinic of the Protestant Infirmary in Lyon

Caluire-et-Cuire, 69300, France

Location

Hospital Center Emile Roux

Le Puy-en-Velay, 43000, France

Location

Hospital Center Saint Luc Saint Joseph

Lyon, 69007, France

Location

Intercommunal Hospital Center of Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Related Publications (4)

  • 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.

    PMID: 32326426BACKGROUND

  • 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.

    PMID: 33089717BACKGROUND

  • 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.

    PMID: 33138848DERIVED

  • 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.

    PMID: 32936948DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Florence Carrouel, Dr

    University Claude Bernard Lyon 1

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

April 27, 2020

Primary Completion

December 11, 2020

Study Completion

December 11, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

FR(4)