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

NCT04820803 | Completed

• 1 other identifier: CPC01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  3 months

• SARS-CoV-2 Nucleocapsid protein in saliva by ELISA

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

  3 months

Study Arms (2)

Cetylpyridinium Chloride (CPC) 0,07%

EXPERIMENTAL

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

Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

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

PLACEBO COMPARATOR

patients who rinse with distilled water mouthwash for 60 seconds

Other: PLACEBO

Interventions

ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE OTHER

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

Cetylpyridinium Chloride (CPC) 0,07%

PLACEBO OTHER

one mouthwash containing distilled (placebo) water for 60 seconds

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rosa Tarrago: lead
• Dentaid SL: collaborator

Study Sites (1)

Seminario Health Center and Lozano Blesa University Clinical Hospital

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Methods; Cetylpyridinium

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized double-blind pilot clinical trial (evaluator and patients) in patients with a diagnosis of COVID-19 and symptoms of the disease.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: February 3, 2021
• Primary Completion: April 29, 2021
• Study Completion: June 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)