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

Not Applicable

Completed

• Conditions: COVID-19; SARS-CoV-2 Infection
• Interventions: Other: PLACEBO; Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

• Registration Number: NCT04820803
• Lead Sponsor: Rosa Tarrago

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.

Study Timeline

• Study Start: 2021-02-03
• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Primary Completion: 2021-04-29
• Study Completion: 2021-06-30
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: Distilled water with the same flavor and coloring as the product to be evaluated	PLACEBO	patients who rinse with distilled water mouthwash for 60 seconds
Cetylpyridinium Chloride (CPC) 0,07%	ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE	patients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seminario Health Center and Lozano Blesa University Clinical Hospital; 🇪🇸 Zaragoza, Spain