Status:

COMPLETED

Double-blind, Randomized, Parallel, Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 (COVID-19) in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 0,07%.

Lead Sponsor:

Dentaid SL

Collaborating Sponsors:

IrsiCaixa

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Conditions:

SARS-CoV-2 Infection

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Double-blind, parallel, randomized, placebo-controlled clinical study. Subjects with confirmed SARS-CoV-2 infection by PCR or antigen rapid test, asymptomatic or with mild COVID-19 symptoms will be in...

Detailed Description

Study procedures will be as follows: The study procedures will take place in 1 day (total interval of 3 hours from the baseline sample collection to the last sample collection). The study samples wi...

Eligibility Criteria

Inclusion

  • Age equal to or greater than 18 years
  • 2\. Confirmation of SARS-CoV-2 infection, determined by PCR or validated rapid antigen test1 from a nasopharyngeal smear performed in ≤3 days.
  • Without symptoms of COVID-19 or with symptoms with ≤3 days of evolution
  • Cognitive and motor ability to perform mouthwashes and gargles
  • Willingness to comply with the requirements of the protocol
  • Understanding of the information provided in relation to the objectives and procedures
  • Provide your consent freely to participate in the study.

Exclusion

  • Use of mouthwashes, in the last 24 hours
  • Use of VITIS pastes and / or PERIO AID gel, in the last 24 hours
  • Four or more days of symptoms compatible with COVID-19.
  • Recent medical diagnosis (≤ 1 month) of pneumonia
  • Cognitive impairment or other reason that, in the investigator's discretion, contraindicates participation in the study
  • Hyposialia

Key Trial Info

Start Date :

February 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 3 2021

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT04757818

Start Date

February 17 2021

End Date

June 3 2021

Last Update

July 19 2021

Active Locations (19)

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Page 1 of 5 (19 locations)

1

CAP Gorg

Badalona, Barcelona, Spain, 08913

2

CAP Gran Sol

Badalona, Barcelona, Spain, 08914

3

CAP St Roc

Badalona, Barcelona, Spain, 08918

4

CAP Barri Llatí

Santa Coloma de Gramenet, Barcelona, Spain, 08921