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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820803
• Other study ID #: CPC01
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2021
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Other:
• ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE
one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds
• PLACEBO
one mouthwash containing distilled (placebo) water for 60 seconds

Locations

Country	Name	City	State
Spain	Seminario Health Center and Lozano Blesa University Clinical Hospital	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Rosa Tarrago	Dentaid SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	SARS-CoV-2 Nucleocapsid protein in saliva by ELISA	Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA	3 months