Clinical trial NCT04757818: 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%.
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%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2
Cetylpyridinium chloride
COVID19
Mouthwash
Saliva sample
RT-qPCR
Lead sponsor: Dentaid SL
Sponsor class: INDUSTRY
Collaborators: name: IrsiCaixa
name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2021-02-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, parallel, placebo-controlled clinical study
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 viral load in saliva samples measured by RT-qPCR
timeFrame: 1 hour and 3 hours after intervention
measure: Nucleocapsid protein levels in saliva samples measured by ELISA
timeFrame: 1 hour and 3 hours after intervention
Secondary outcomes:
measure: SARS-CoV-2 viral load in saliva samples determined by RT-qPCR
timeFrame: 1 hour after intervention
measure: SARS-CoV-2 viral load in saliva samples determined by RT-qPCR
timeFrame: 3 hours after intervention
measure: Sensitivity and specificity of different rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples
timeFrame: 1 hour and 3 hours after intervention
measure: Intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo
timeFrame: Baseline, 1 hour and 3 hours after intervention
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: CAP Gorg
state: Barcelona
city: Badalona
country: Spain
facility: CAP Gran Sol
state: Barcelona
city: Badalona
country: Spain
facility: CAP St Roc
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: CAP Barri Llatí
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: CAP Fondo
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: CAP Santa Rosa
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: CAP Singuerlin
state: Barcelona
city: Badalona
country: Spain
facility: CAP Dr Robert
city: Bellavista
country: Spain
facility: CAP Les Franqueses del Vallès
city: Canovelles
country: Spain
facility: CAP Canovelles/Granollers Oest
city: Granollers
country: Spain
facility: CAP Granollers Centre
city: Mataró
country: Spain
facility: ABS Gatassa
city: Mollet Del Vallès
country: Spain
facility: EAP Mollet Est
city: Montornés del Vallès
country: Spain
facility: CAP Montornés/Montmeló
city: Palau-solità i Plegamans
country: Spain
facility: CAP Palau
city: Parets del Vallès
country: Spain
facility: EAP Parets del Vallès
city: Sant Celoni
country: Spain
facility: CAP Sant Celoni
city: Santa Perpètua de Mogoda
country: Spain
facility: CAP Santa Perpètua
city: Vilassar de Mar
country: Spain
facility: EAP Vilassar de Mar
Study officials:
References: