CPC COVID: 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%.

Sponsor

Dentaid SL (Industry)

Overall Status

Completed

CT.gov ID

NCT04757818

Collaborator

IrsiCaixa (Other), Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (Other)

118

Enrollment

Locations

Arms

3.5

Actual Duration (Months)

6.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection	Other: 0.07% cetylpyridinium chloride (CPC) in mouthwash Other: Distilled water with the same colorant as the experimental product	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blind, randomized, parallel, placebo-controlled clinical studyDouble-blind, randomized, parallel, placebo-controlled clinical study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

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%

Actual Study Start Date :

Feb 17, 2021

Actual Primary Completion Date :

May 25, 2021

Actual Study Completion Date :

Jun 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.07% cetylpyridinium chloride (CPC) in mouthwash Single dose. A mouthwash and gargles with 15 ml of product for 1 minute.	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.
Placebo Comparator: Distilled water with the same colorant as the experimental product 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 A mouthwash and gargles with 15 ml of distilled water for 1 minute

Arm

Intervention/Treatment

Experimental: 0.07% cetylpyridinium chloride (CPC) in mouthwash

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

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.

Placebo Comparator: Distilled water with the same colorant as the experimental product

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

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

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 viral load in saliva samples measured by RT-qPCR [1 hour and 3 hours after intervention]
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
Nucleocapsid protein levels in saliva samples measured by ELISA [1 hour and 3 hours after intervention]
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

Secondary Outcome Measures

SARS-CoV-2 viral load in saliva samples determined by RT-qPCR [1 hour after intervention]
To determine the reduction of SARS-CoV-2 viral load by RT-qPCR in saliva samples
SARS-CoV-2 viral load in saliva samples determined by RT-qPCR [3 hours after intervention]
To determine the reduction of SARS-CoV-2 viral load by RT-qPCR in saliva samples
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]
To compare the sensitivity and specificity of rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples
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]
To determine the intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age equal to or greater than 18 years
1. 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAP Gorg	Badalona	Barcelona	Spain	08913
2	CAP Gran Sol	Badalona	Barcelona	Spain	08914
3	CAP St Roc	Badalona	Barcelona	Spain	08918
4	CAP Barri Llatí	Santa Coloma De Gramenet	Barcelona	Spain	08921
5	CAP Fondo	Santa Coloma De Gramenet	Barcelona	Spain	08923
6	CAP Santa Rosa	Santa Coloma De Gramenet	Barcelona	Spain	08923
7	CAP Singuerlin	Santa Coloma De Gramenet	Barcelona	Spain	08924
8	CAP Dr Robert	Badalona		Spain	08911
9	CAP Les Franqueses del Vallès	Bellavista		Spain	08521
10	CAP Canovelles/Granollers Oest	Canovelles		Spain	08420
11	CAP Granollers Centre	Granollers		Spain	08401
12	ABS Gatassa	Mataró		Spain	08302
13	EAP Mollet Est	Mollet Del Vallès		Spain	08470
14	CAP Montornés/Montmeló	Montornés del Vallès		Spain	08170
15	CAP Palau	Palau-solità i Plegamans		Spain	08184
16	EAP Parets del Vallès	Parets del Vallès		Spain	08150
17	CAP Sant Celoni	Sant Celoni		Spain	08470
18	CAP Santa Perpètua	Santa Perpètua de Mogoda		Spain	08130
19	EAP Vilassar de Mar	Vilassar de Mar		Spain	08340