Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19

Sponsor

Rosa Tarrago (Other)

Overall Status

Completed

CT.gov ID

NCT04820803

Collaborator

Dentaid SL (Industry)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV-2 Infection	Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE Other: PLACEBO	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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

Official Title:

PILOT CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL INTERVENTION WITH CETIL PYRIDINIUM CHLORIDE TO REDUCE THE VIRAL LOAD OF SARS-CoV-2

Actual Study Start Date :

Feb 3, 2021

Actual Primary Completion Date :

Apr 29, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cetylpyridinium Chloride (CPC) 0,07% patients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds	Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds
Placebo Comparator: Placebo: Distilled water with the same flavor and coloring as the product to be evaluated patients who rinse with distilled water mouthwash for 60 seconds	Other: PLACEBO one mouthwash containing distilled (placebo) water for 60 seconds

Arm

Intervention/Treatment

Experimental: Cetylpyridinium Chloride (CPC) 0,07%

patients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds

Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds

Placebo Comparator: Placebo: Distilled water with the same flavor and coloring as the product to be evaluated

patients who rinse with distilled water mouthwash for 60 seconds

Other: PLACEBO

one mouthwash containing distilled (placebo) water for 60 seconds

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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