Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- SARS CoV-2 Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Double (Participant, 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.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 compatib...
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.
Tracking Information
- NCT #
- NCT04820803
- Collaborators
- Dentaid SL
- Investigators
- Not Provided
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