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

Rosa Tarrago

Status

Completed

Conditions

COVID-19

SARS-CoV-2 Infection

Treatments

Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

Other: PLACEBO

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04820803

CPC01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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