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Completed

NCT Number: NCT04820803

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seminario Health Center and Lozano Blesa University Clinical Hospital

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE

Other

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

Placebo

Other

one mouthwash containing distilled (placebo) water for 60 seconds

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Rosa Tarrago

Other

Collaborators

  • Dentaid SL

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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