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

February 10, 2021 updated by: Carrouel Florence, Claude Bernard University

COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caluire-et-Cuire, France, 69300
        • Clinic of the Protestant Infirmary in Lyon
      • Le Puy en Velay, France, 43000
        • Hospital Center Emile Roux
      • Lyon, France, 69007
        • Hospital Center Saint Luc Saint Joseph
      • Mont de Marsan, France, 40000
        • Intercommunal Hospital Center of Mont de Marsan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mouth rinse with antiviral
Device: mouthrinse with bêta-cyclodextrin and citrox
3 daily mouthrinses for 7 days
Placebo Comparator: mouth rinse without antiviral
Device: mouthrinse without bêta-cyclodextrin and citrox
3 daily mouthrinses for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days
Time Frame: 7 days
Quantitative PCR experiments will be performed and a quantitative analysis of the salivary samples will be made
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claude Bernard University

Collaborators

Hospices Civils de Lyon

Investigators

  • Study Director: Florence Carrouel, Dr, University Claude Bernard Lyon 1

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

December 11, 2020

Study Completion (Actual)

December 11, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBCovid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID19

Clinical Trials on mouthrinse with bêta-cyclodextrin and citrox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe