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

July 1, 2021 updated by: Rosa Tarrago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Seminario Health Center and Lozano Blesa University Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples
Time Frame: 3 months
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes
3 months
SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
Time Frame: 3 months
Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosa Tarrago

Collaborators

Dentaid SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Actual)

April 29, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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