NCT04352959: BBCovid

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

Completed NA Last updated 11 February 2021

What this trial tests

NA trial testing mouthrinse with bêta-cyclodextrin and citrox in COVID19 in 176 participants. Completed in 11 December 2020.

Timeline

27 April 2020

Primary endpoint
11 December 2020

11 December 2020

Quick facts

Lead sponsor	Claude Bernard University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	176
Start date	27 April 2020
Primary completion	11 December 2020
Estimated completion	11 December 2020
Sites	4 locations across France

Drugs / interventions tested

• mouthrinse with bêta-cyclodextrin and citrox
• mouthrinse without bêta-cyclodextrin and citrox

Conditions studied

• COVID19 — all drugs for COVID19 →
• Mouthwash — all drugs for Mouthwash →
• Saliva — all drugs for Saliva →

Sponsor

Claude Bernard University

Who can join

Adults 18 to 85, any sex, with COVID19 or Mouthwash. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of an antiviral mouthwash as a barrier measure in the SARS-CoV-2 transmission in adults with asymptomatic to mild COVID-19: a multicentre, randomized, double-blind controlled trial.
   Carrouel F, Valette M, Gadea E, Esparcieux A, et al · · 2021 · cited 39× · PMID 34044151 · DOI 10.1016/j.cmi.2021.05.028
2. 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.
   Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 39× · PMID 32936948 · DOI 10.1002/14651858.cd013627.pub2
3. Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection.
   Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 25× · PMID 32936949 · DOI 10.1002/14651858.cd013626.pub2
4. Review of the use of nasal and oral antiseptics during a global pandemic.
   Stathis C, Victoria N, Loomis K, Nguyen SA, et al · · 2021 · cited 21× · PMID 33464122 · DOI 10.2217/fmb-2020-0286
5. Antimicrobial mouthwashes (gargling) and nasal sprays to protect healthcare workers when undertaking aerosol-generating procedures (AGPs) on patients without suspected or confirmed COVID-19 infection.
   Burton MJ, Clarkson JE, Goulao B, Glenny AM, et al · · 2020 · cited 16× · PMID 32936947 · DOI 10.1002/14651858.cd013628.pub2
6. Saliva Quantification of SARS-CoV-2 in Real-Time PCR From Asymptomatic or Mild COVID-19 Adults.
   Carrouel F, Gadea E, Esparcieux A, Dimet J, et al · · 2021 · cited 15× · PMID 35046915 · DOI 10.3389/fmicb.2021.786042
7. 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.
   Carrouel F, Viennot S, Valette M, Cohen JM, et al · · 2020 · cited 8× · PMID 33138848 · DOI 10.1186/s13063-020-04846-6