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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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