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

Primary Purpose

COVID19, Mouthwash, Saliva

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mouthrinse with bêta-cyclodextrin and citrox
mouthrinse without bêta-cyclodextrin and citrox
Sponsored by
Claude Bernard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID19 focused on measuring covid19, SARS-CoV-2, mouthrinses, antiviral, bêta-cyclodextrin, citrox

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic of the Protestant Infirmary in Lyon
  • Hospital Center Emile Roux
  • Hospital Center Saint Luc Saint Joseph
  • Intercommunal Hospital Center of Mont de Marsan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mouth rinse with antiviral

mouth rinse without antiviral

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days
Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made

Full Information

First Posted
April 15, 2020
Last Updated
February 10, 2021
Sponsor
Claude Bernard University
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04352959
Brief Title
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
Acronym
BBCovid
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Claude Bernard University
Collaborators
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Mouthwash, Saliva
Keywords
covid19, SARS-CoV-2, mouthrinses, antiviral, bêta-cyclodextrin, citrox

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mouth rinse with antiviral
Arm Type
Active Comparator
Arm Title
mouth rinse without antiviral
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
mouthrinse with bêta-cyclodextrin and citrox
Intervention Description
3 daily mouthrinses for 7 days
Intervention Type
Device
Intervention Name(s)
mouthrinse without bêta-cyclodextrin and citrox
Intervention Description
3 daily mouthrinses for 7 days
Primary Outcome Measure Information:
Title
Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days
Description
Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days
Description
Quantitative PCR experiments will be performed and a quantitative analysis of the nasal samples will be made
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Carrouel, Dr
Organizational Affiliation
University Claude Bernard Lyon 1
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of the Protestant Infirmary in Lyon
City
Caluire-et-Cuire
ZIP/Postal Code
69300
Country
France
Facility Name
Hospital Center Emile Roux
City
Le Puy en Velay
ZIP/Postal Code
43000
Country
France
Facility Name
Hospital Center Saint Luc Saint Joseph
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Intercommunal Hospital Center of Mont de Marsan
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32326426
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.
Results Reference
background
PubMed Identifier
33089717
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.
Results Reference
background
PubMed Identifier
33138848
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.
Results Reference
derived
PubMed Identifier
32936948
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.
Results Reference
derived

Learn more about this trial

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

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