COVID19BBCovidNCT04352959
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
A study testing mouthrinse with bêta-cyclodextrin and citrox and mouthrinse without bêta-cyclodextrin and citrox in people with COVID19 and Mouthwash, run by Claude Bernard University at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- mouthrinse with bêta-cyclodextrin and citrox and mouthrinse without bêta-cyclodextrin and citrox
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Apr 2020to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Breastfeeding
- Inability to comply with protocol
- Lack of written agreement
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinic of the Protestant Infirmary in Lyon
Caluire-et-Cuire, 69300
Hospital Center Emile Roux
Le Puy-en-Velay, 43000
Hospital Center Saint Luc Saint Joseph
Lyon, 69007
Intercommunal Hospital Center of Mont de Marsan
Mont-de-Marsan, 40000
About this study
Official title: 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.
- Being tested
- mouthrinse with bêta-cyclodextrin and citrox, mouthrinse without bêta-cyclodextrin and citrox
- Keywords
- covid19, SARS-CoV-2, mouthrinses, antiviral, bêta-cyclodextrin, citrox
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthrinse with bêta-cyclodextrin and citroxDevice
3 daily mouthrinses for 7 days
mouthrinse without bêta-cyclodextrin and citroxDevice
3 daily mouthrinses for 7 days
| Study group | Role | What they receive |
|---|---|---|
| mouth rinse with antiviral | Active comparator | Not described Receives: Device: mouthrinse with bêta-cyclodextrin and citrox |
| mouth rinse without antiviral | Placebo comparator | Not described Receives: Device: mouthrinse without bêta-cyclodextrin and citrox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start27 Apr 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Carrouel Florence, Claude Bernard University
- Investigators
- Florence Carrouel, Dr, Study director, University Claude Bernard Lyon 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352959
- Sponsor's protocol ID
- BBCovid
- Acronym
- BBCovid
- Status last verified
- Feb 2021
- First submitted
- 15 Apr 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32326426Carrouel 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.
PubMed 33089717Carrouel 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.
PubMed 33138848Burton 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.
PubMed 32936948
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses: Double-blind, Randomized, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04352959
- Acronym / sponsor ID
- BBCovid / BBCovid
- Keywords
- covid19, SARS-CoV-2, mouthrinses, antiviral, bêta-cyclodextrin, citrox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Inability to comply with protocol
- Lack of written agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthrinse with bêta-cyclodextrin and citrox3 daily mouthrinses for 7 days | Device | mouth rinse with antiviral |
| mouthrinse without bêta-cyclodextrin and citrox3 daily mouthrinses for 7 days | Device | mouth rinse without antiviral |
Primary outcome
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
1 secondary outcome
Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 7 days
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 32326426Carrouel 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.
- Background: PubMed 33089717Carrouel 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.
- Derived from this study: PubMed 33138848Carrouel 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.
- Derived from this study: PubMed 32936948Burton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Carrouel, Dr study director
University Claude Bernard Lyon 1
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mouthrinse with bêta-cyclodextrin and citrox and mouthrinse without bêta-cyclodextrin and citrox in people with COVID19 and Mouthwash, run by Claude Bernard University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline amount of SARS-CoV-2 in salivary samples at 7 days (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352959, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.