COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
cetylpyridinium, SARS-CoV-2, COVID-19, mouthwashes
Brief summary
Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
Detailed description
The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the Seminario health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.
Interventions
OTHERORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE
one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds
OTHERPLACEBO
one mouthwash containing distilled (placebo) water for 60 seconds
Sponsors
Dentaid SL
Rosa Tarrago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomized double-blind pilot clinical trial (evaluator and patients) in patients with a diagnosis of COVID-19 and symptoms of the disease.
Intervention model description
Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 40 subjects in the first group and 40 in the second were required to detect a difference equal to or greater than 5 units. The common standard deviation is assumed to be 10 (12). A loss to follow-up rate of 20% has been estimated.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Outpatients older than 18 years and younger than 80 years. * Patients with a medical indication for a diagnostic test for active infection to SARS-CoV-2 * Patients who present mild symptoms typical of COVID-19 and who have less than three days of evolution * Patients who have cognitive and motor skills to perform mouthwash correctly. * Patients who understand and speak Spanish * Patients who freely give their consent to participate in the study, after a correct understanding of its objectives and procedures.
Exclusion criteria
* Patients with hospitalization criteria (moderate or severe symptoms) * Vulnerable populations such as pregnant, lactating, * Patients with recent medical diagnosis (≤ 1 month) of pneumonia * Patients with hyposialia * Patients with consumption of oral antiseptics (in the form of mouthwash containing CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with CPC during the last month. * Patients with cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples | 3 months | Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes |
| SARS-CoV-2 Nucleocapsid protein in saliva by ELISA | 3 months | Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA |
Countries
Spain
Outcome results
None listed