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OpenTrials
Completed

NCT Number: NCT04352959

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mouthwash Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Saliva Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of the Protestant Infirmary in Lyon, Caluire-et-Cuire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mouthrinse with bêta-cyclodextrin and citrox

Device

3 daily mouthrinses for 7 days

mouthrinse without bêta-cyclodextrin and citrox

Device

3 daily mouthrinses for 7 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: BBCovid

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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