SARS-CoV-2 InfectionCPC COVIDNCT04757818
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%.
A study testing 0.07% cetylpyridinium chloride (CPC) in mouthwash and Distilled water with the same colorant as the experimental product in people with SARS-CoV-2 Infection, run by Dentaid SL at 19 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- 0.07% cetylpyridinium chloride (CPC) in mouthwash and Distilled water with the same colorant as the experimental product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 19 sitesSpain
- Study dates
- 17 Feb 2021to 3 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years
- 2. 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
CAP Gorg
Badalona, Barcelona, 08913
CAP Gran Sol
Badalona, Barcelona, 08914
CAP St Roc
Badalona, Barcelona, 08918
CAP Dr Robert
Badalona, 08911
CAP Les Franqueses del Vallès
Bellavista, 08521
CAP Canovelles/Granollers Oest
Canovelles, 08420
CAP Granollers Centre
Granollers, 08401
ABS Gatassa
Mataró, 08302
EAP Mollet Est
Mollet del Vallès, 08470
CAP Montornés/Montmeló
Montornés Del Vallès, 08170
CAP Palau
Palau-solità i Plegamans, 08184
EAP Parets del Vallès
Parets del Vallès, 08150
CAP Sant Celoni
Sant Celoni, 08470
CAP Barri Llatí
Santa Coloma de Gramenet, Barcelona, 08921
CAP Fondo
Santa Coloma de Gramenet, Barcelona, 08923
CAP Santa Rosa
Santa Coloma de Gramenet, Barcelona, 08923
CAP Singuerlin
Santa Coloma de Gramenet, Barcelona, 08924
CAP Santa Perpètua
Santa Perpètua de Mogoda, 08130
EAP Vilassar de Mar
Vilassar de Mar, 08340
About this study
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%
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.
Read the 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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- 0.07% cetylpyridinium chloride (CPC) in mouthwash, Distilled water with the same colorant as the experimental product
- Keywords
- SARS-CoV-2, Cetylpyridinium chloride, COVID19, Mouthwash, Saliva sample, RT-qPCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.07% cetylpyridinium chloride (CPC) in mouthwashOther
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 productOther
A mouthwash and gargles with 15 ml of distilled water for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| 0.07% cetylpyridinium chloride (CPC) in mouthwash | Experimental | Single dose. A mouthwash and gargles with 15 ml of product for 1 minute. Receives: 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. Receives: Other: Distilled water with the same colorant as the experimental product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 hour and 3 hours after intervention
Secondary outcomes (4)
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
Measured: 1 hour after intervention
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
Measured: 3 hours after intervention
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
Measured: 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
To determine the intraindividual difference in SARS-CoV-2 infectivity in vitro before and after treatment with a 0.07% CPC or placebo
Measured: Baseline, 1 hour and 3 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start17 Feb 2021
- Primary completion25 May 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, parallel, placebo-controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentaid SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757818
- Sponsor's protocol ID
- CPC COVID
- Acronym
- CPC COVID
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%
- ClinicalTrials.gov ID
- NCT04757818
- Acronym / sponsor ID
- CPC COVID / CPC COVID
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, Cetylpyridinium chloride, COVID19, Mouthwash, Saliva sample, RT-qPCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Dentaid SLIndustry (pharma, biotech, devices)
- Collaborators
- IrsiCaixa, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, parallel, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| 0.07% cetylpyridinium chloride (CPC) in mouthwash | Experimental | Other: 0.07% cetylpyridinium chloride (CPC) in mouthwashSingle dose. A mouthwash and gargles with 15 ml of product for 1 minute. |
| Distilled water with the same colorant as the experimental product | Placebo comparator | Other: Distilled water with the same colorant as the experimental productSingle dose. A mouthwash and gargles with 15 ml of product for 1 minute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age equal to or greater than 18 years
- 2. 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.07% cetylpyridinium chloride (CPC) in mouthwashA mouthwash and gargles with 15 ml of 0.07% cetylpyridinium chloride (CPC) in mouthwash for 1 minute. | Other | 0.07% cetylpyridinium chloride (CPC) in mouthwash |
| Distilled water with the same colorant as the experimental productA mouthwash and gargles with 15 ml of distilled water for 1 minute | Other | Distilled water with the same colorant as the experimental product |
Primary outcome
SARS-CoV-2 viral load in saliva samples measured by RT-qPCR
Time frame: 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
Time frame: 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
4 secondary outcomes
SARS-CoV-2 viral load in saliva samples determined by RT-qPCR
Time frame: 1 hour after intervention
SARS-CoV-2 viral load in saliva samples determined by RT-qPCR
Time frame: 3 hours after intervention
Sensitivity and specificity of different rapid SARS-CoV-2 antigen tests compared to RT-qPCR in saliva samples
Time frame: 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
Time frame: Baseline, 1 hour and 3 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.07% cetylpyridinium chloride (CPC) in mouthwash and Distilled water with the same colorant as the experimental product in people with SARS-CoV-2 Infection, run by Dentaid SL at 19 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 viral load in saliva samples measured by RT-qPCR (time frame: 1 hour and 3 hours after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.