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%.

SARS-CoV-2 Infection Clinical Trial

— CPC COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757818
• Other study ID #: CPC COVID
• Status: Completed
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: June 3, 2021

Study information

• Verified date: July 2021
• Source: Dentaid SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study procedures will be as follows:

The study procedures will take place in 1 day (total interval of 3 hours from the baseline sample collection to the last sample collection).

The study samples will be saliva samples (1-1.5 ml) collected at baseline and 1 and 3 hours after the intervention. The intervention will be the use of a mouthwash (washes and gargles) for one minute with 15 ml of either CPC Protect® (CPC group) or colored distilled water (control group).

Candidates with a positive result of PCR or antigen rapid test for SARS-CoV-2 will be identified by study nurses, certified nursing assistants, and dentists at primary health care centers of the Metro Nord health administrative region of Catalonia. The investigator will obtain the candidates' informed consent and will verify that the subject meets all the inclusion criteria and none of the exclusion criteria. The researcher will assign a correlative kit number (randomization) and instruct the subject in the procedure of self-collection of a saliva sample.

Baseline: The subject will self-collect the baseline saliva sample in front of the investigator, who will be able to correct the errors observed in the procedure.

Hour 0: After the obtention of the baseline saliva sample, the subject will rinse and gargle with 15 mL of mouthwash (experimental or placebo) for 1 minute (30 seconds of rinsing and 30 seconds of gargling).

The researcher will indicate to the subject the hours in which the second and third saliva samples should be taken. The subject must avoid brushing their teeth, eating and drinking, except water, until the rest of the saliva samples are collected and may return home.

Hour 1: One hour after mouthwash use, the subject will self-collect the second saliva sample (1-hour sample).

Hour 3: Three hours after mouthwash use, the subject will self-collect the third saliva sample (3-hour sample).

The investigator will contact the subject to confirm the correct collection of saliva samples (1 hour and 3 hours) at the indicated times and will record it in the study application.

Saliva samples will be collected at the center and/or at the subjects' residence and will be transferred to the Clinical Laboratory Metropolitana Nord in Hospital Universitari Germans Trias i Pujol (HUGTiP) for the viral load analysis by RT-PCR. The remaining saliva volume will be transferred to IrsiCaixa's Laboratory (located in the HUGTiP) for the ELISA analysis and the rest of the analysis, and for storage in those cases where the subject's IC is available for it.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 3, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age equal to or greater than 18 years

2. 2. Confirmation of SARS-CoV-2 infection, determined by PCR or validated rapid antigen test1 from a nasopharyngeal smear performed in =3 days.

3. Without symptoms of COVID-19 or with symptoms with =3 days of evolution

4. Cognitive and motor ability to perform mouthwashes and gargles

5. Willingness to comply with the requirements of the protocol

6. Understanding of the information provided in relation to the objectives and procedures

7. Provide your consent freely to participate in the study.

Exclusion Criteria:

1. Use of mouthwashes, in the last 24 hours

2. Use of VITIS pastes and / or PERIO AID gel, in the last 24 hours

3. Four or more days of symptoms compatible with COVID-19.

4. Recent medical diagnosis (= 1 month) of pneumonia

5. Cognitive impairment or other reason that, in the investigator's discretion, contraindicates participation in the study

6. Hyposialia

Related Conditions & MeSH terms

• SARS-CoV-2 Infection

Intervention

Other:
• 0.07% cetylpyridinium chloride (CPC) in mouthwash
A mouthwash and gargles with 15 ml of 0.07% cetylpyridinium chloride (CPC) in mouthwash for 1 minute.
• Distilled water with the same colorant as the experimental product
A mouthwash and gargles with 15 ml of distilled water for 1 minute

Locations

Country	Name	City	State
Spain	CAP Dr Robert	Badalona
Spain	CAP Gorg	Badalona	Barcelona
Spain	CAP Gran Sol	Badalona	Barcelona
Spain	CAP St Roc	Badalona	Barcelona
Spain	CAP Les Franqueses del Vallès	Bellavista
Spain	CAP Canovelles/Granollers Oest	Canovelles
Spain	CAP Granollers Centre	Granollers
Spain	ABS Gatassa	Mataró
Spain	EAP Mollet Est	Mollet Del Vallès
Spain	CAP Montornés/Montmeló	Montornés del Vallès
Spain	CAP Palau	Palau-solità i Plegamans
Spain	EAP Parets del Vallès	Parets del Vallès
Spain	CAP Sant Celoni	Sant Celoni
Spain	CAP Barri Llatí	Santa Coloma De Gramenet	Barcelona
Spain	CAP Fondo	Santa Coloma De Gramenet	Barcelona
Spain	CAP Santa Rosa	Santa Coloma De Gramenet	Barcelona
Spain	CAP Singuerlin	Santa Coloma De Gramenet	Barcelona
Spain	CAP Santa Perpètua	Santa Perpètua de Mogoda
Spain	EAP Vilassar de Mar	Vilassar de Mar

Sponsors (3)

Lead Sponsor	Collaborator
Dentaid SL	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, IrsiCaixa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	SARS-CoV-2 viral load in saliva samples determined by RT-qPCR	To determine the reduction of SARS-CoV-2 viral load by RT-qPCR in saliva samples	1 hour after intervention
Secondary	SARS-CoV-2 viral load in saliva samples determined by RT-qPCR	To determine the reduction of SARS-CoV-2 viral load by RT-qPCR in saliva samples	3 hours after intervention
Secondary	Sensitivity and specificity of different rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples	To compare the sensitivity and specificity of rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples	1 hour and 3 hours after intervention
Secondary	Intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo	To determine the 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