Double-blind, Randomized, Parallel, Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 (COVID-19) in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 0,07%.

NCT04757818 | Completed

• 1 other identifier: CPC COVID
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 19

Brief Summary

Double-blind, parallel, randomized, placebo-controlled clinical study. Subjects with confirmed SARS-CoV-2 infection by PCR or antigen rapid test, asymptomatic or with mild COVID-19 symptoms will be included. Subjects who agree to participate and who are eligible will be randomized to perform a mouth rinse and gargle with a 0.07% CPC mouthwash (experimental) or with a substance of the same color (placebo). Saliva samples will be collected at baseline (i.e., before wash) and 1 hour and 3 hours after wash. Saliva samples will be transferred to a central laboratory for SARS-CoV-2 viral load determination, nucleocapsid protein levels determination, rapid antigen testing, viral infectivity analysis and storage.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; Cetylpyridinium chloride; COVID19; Mouthwash; Saliva sample; RT-qPCR

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 viral load in saliva samples measured by RT-qPCR

  To determine the efficacy of a 0.07% CPC mouthwash in reducing the viral load of SARS-CoV-2 in saliva samples, measured by RT-qPCR, in subjects with confirmed SARS-CoV-2 infection

  1 hour and 3 hours after intervention

• Nucleocapsid protein levels in saliva samples measured by ELISA

  To determine the efficacy of a 0.07% CPC mouthwash in increasing the nucleocapsid protein levels in saliva samples, measured by high-sensitivity quantitative ELISA (ImmunoDiagnostics), in subjects with confirmed SARS-CoV-2 infection

  1 hour and 3 hours after intervention

Secondary Outcomes (4)

• SARS-CoV-2 viral load in saliva samples determined by RT-qPCR

  1 hour after intervention

• SARS-CoV-2 viral load in saliva samples determined by RT-qPCR

  3 hours after intervention

• Sensitivity and specificity of different rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples

  1 hour and 3 hours after intervention

• Intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo

  Baseline, 1 hour and 3 hours after intervention

Study Arms (2)

0.07% cetylpyridinium chloride (CPC) in mouthwash

EXPERIMENTAL

Single dose. A mouthwash and gargles with 15 ml of product for 1 minute.

Other: 0.07% cetylpyridinium chloride (CPC) in mouthwash

Distilled water with the same colorant as the experimental product

PLACEBO COMPARATOR

Single dose. A mouthwash and gargles with 15 ml of product for 1 minute.

Other: Distilled water with the same colorant as the experimental product

Interventions

0.07% cetylpyridinium chloride (CPC) in mouthwash OTHER

A mouthwash and gargles with 15 ml of 0.07% cetylpyridinium chloride (CPC) in mouthwash for 1 minute.

0.07% cetylpyridinium chloride (CPC) in mouthwash

Distilled water with the same colorant as the experimental product OTHER

A mouthwash and gargles with 15 ml of distilled water for 1 minute

Distilled water with the same colorant as the experimental product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or greater than 18 years
• \. Confirmation of SARS-CoV-2 infection, determined by PCR or validated rapid antigen test1 from a nasopharyngeal smear performed in ≤3 days.
• Without symptoms of COVID-19 or with symptoms with ≤3 days of evolution
• Cognitive and motor ability to perform mouthwashes and gargles
• Willingness to comply with the requirements of the protocol
• Understanding of the information provided in relation to the objectives and procedures
• Provide your consent freely to participate in the study.

You may not qualify if:

• Use of mouthwashes, in the last 24 hours
• Use of VITIS pastes and / or PERIO AID gel, in the last 24 hours
• Four or more days of symptoms compatible with COVID-19.
• Recent medical diagnosis (≤ 1 month) of pneumonia
• Cognitive impairment or other reason that, in the investigator's discretion, contraindicates participation in the study
• Hyposialia

Sponsors & Collaborators

• Dentaid SL: lead
• IrsiCaixa: collaborator
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (19)

CAP Gorg

Badalona, Barcelona, 08913, Spain

Location

CAP Gran Sol

Badalona, Barcelona, 08914, Spain

Location

CAP St Roc

Badalona, Barcelona, 08918, Spain

Location

CAP Barri Llatí

Santa Coloma de Gramenet, Barcelona, 08921, Spain

Location

CAP Fondo

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

CAP Santa Rosa

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

CAP Singuerlin

Santa Coloma de Gramenet, Barcelona, 08924, Spain

Location

CAP Dr Robert

Badalona, 08911, Spain

Location

CAP Les Franqueses del Vallès

Bellavista, 08521, Spain

Location

CAP Canovelles/Granollers Oest

Canovelles, 08420, Spain

Location

CAP Granollers Centre

Granollers, 08401, Spain

Location

ABS Gatassa

Mataró, 08302, Spain

Location

EAP Mollet Est

Mollet del Vallès, 08470, Spain

Location

CAP Montornés/Montmeló

Montornés Del Vallès, 08170, Spain

Location

CAP Palau

Palau-solità i Plegamans, 08184, Spain

Location

EAP Parets del Vallès

Parets del Vallès, 08150, Spain

Location

CAP Sant Celoni

Sant Celoni, 08470, Spain

Location

CAP Santa Perpètua

Santa Perpètua de Mogoda, 08130, Spain

Location

EAP Vilassar de Mar

Vilassar de Mar, 08340, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cetylpyridinium; cytidylyl-(3'-5')-cytidine

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)

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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, parallel, placebo-controlled clinical study

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 17, 2021
• Study Start: February 17, 2021
• Primary Completion: May 25, 2021
• Study Completion: June 3, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

ES (19)