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

Primary Purpose

COVID-19, SARS-CoV-2 Infection

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

PLACEBO

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring cetylpyridinium, SARS-CoV-2, COVID-19, mouthwashes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seminario Health Center and Lozano Blesa University Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cetylpyridinium Chloride (CPC) 0,07%

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

Arm Description

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

patients who rinse with distilled water mouthwash for 60 seconds

Outcomes

Primary Outcome Measures

Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples

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

Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA

Secondary Outcome Measures

Full Information

NCT ID

NCT04820803

First Posted

March 23, 2021

Last Updated

July 1, 2021

Sponsor

Rosa Tarrago

Collaborators

Dentaid SL

1. Study Identification

Unique Protocol Identification Number

NCT04820803

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 3, 2021 (Actual)

Primary Completion Date

April 29, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rosa Tarrago

Collaborators

Dentaid SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, SARS-CoV-2 Infection

Keywords

cetylpyridinium, SARS-CoV-2, COVID-19, mouthwashes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Masking Description

Randomized double-blind pilot clinical trial (evaluator and patients) in patients with a diagnosis of COVID-19 and symptoms of the disease.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetylpyridinium Chloride (CPC) 0,07%

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

patients who rinse with distilled water mouthwash for 60 seconds

Intervention Type

Other

Intervention Name(s)

ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

PLACEBO

Intervention Description

one mouthwash containing distilled (placebo) water for 60 seconds

Primary Outcome Measure Information:

Title

Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples

Description

Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes

Time Frame

3 months

Title

SARS-CoV-2 Nucleocapsid protein in saliva by ELISA

Description

Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Seminario Health Center and Lozano Blesa University Clinical Hospital

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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