COVID-19NCT04820803
Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19
A study testing ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE in people with COVID-19 and SARS-CoV-2 Infection, run by Rosa Tarrago at 1 site in Spain.
Trial summary
Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2021to 30 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients older than 18 years and younger than 80 years.
- Patients with a medical indication for a diagnostic test for active infection to SARS-CoV-2
- Patients who present mild symptoms typical of COVID-19 and who have less than three days of evolution
- Patients who have cognitive and motor skills to perform mouthwash correctly.
- Patients who understand and speak Spanish
- Patients who freely give their consent to participate in the study, after a correct understanding of its objectives and procedures.
Who cannot join
- Patients with hospitalization criteria (moderate or severe symptoms)
- Vulnerable populations such as pregnant, lactating,
- Patients with recent medical diagnosis (≤ 1 month) of pneumonia
- Patients with hyposialia
- Patients with consumption of oral antiseptics (in the form of mouthwash containing CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with CPC during the last month.
- Patients with cognitive impairment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Seminario Health Center and Lozano Blesa University Clinical Hospital
Zaragoza, 50009
About this study
Official title: PILOT CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL INTERVENTION WITH CETIL PYRIDINIUM CHLORIDE TO REDUCE THE VIRAL LOAD OF SARS-CoV-2
Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
Read the detailed description
The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE, PLACEBO
- Keywords
- cetylpyridinium, SARS-CoV-2, COVID-19, mouthwashes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDEOther
one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds
PLACEBOOther
one mouthwash containing distilled (placebo) water for 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Cetylpyridinium Chloride (CPC) 0,07% | Experimental | patients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds Receives: Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE |
| Placebo: Distilled water with the same flavor and coloring as the product to be evaluated | Placebo comparator | patients who rinse with distilled water mouthwash for 60 seconds Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes
Measured: 3 months
SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start3 Feb 2021
- Primary completion29 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 40 subjects in the first group and 40 in the second were required to detect a difference equal to or greater than 5 units. The common standard deviation is assumed to be 10 (12). A loss to follow-up rate of 20% has been estimated.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosa Tarrago
- Sponsor type
- University, hospital or other
- Collaborators
- Dentaid SL
- Responsible party
- Sponsor-investigator, Rosa Tarrago, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820803
- Sponsor's protocol ID
- CPC01
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL INTERVENTION WITH CETIL PYRIDINIUM CHLORIDE TO REDUCE THE VIRAL LOAD OF SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04820803
- Acronym / sponsor ID
- CPC01
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- cetylpyridinium, SARS-CoV-2, COVID-19, mouthwashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rosa TarragoUniversity, hospital or other
- Collaborators
- Dentaid SL
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Mar 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.
Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
Detailed description
The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 40 subjects in the first group and 40 in the second were required to detect a difference equal to or greater than 5 units. The common standard deviation is assumed to be 10 (12). A loss to follow-up rate of 20% has been estimated.
| Arm | Type | Receives |
|---|---|---|
| Cetylpyridinium Chloride (CPC) 0,07% | Experimental | Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDEpatients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds |
| Placebo: Distilled water with the same flavor and coloring as the product to be evaluated | Placebo comparator | Other: PLACEBOpatients who rinse with distilled water mouthwash for 60 seconds |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients older than 18 years and younger than 80 years.
- Patients with a medical indication for a diagnostic test for active infection to SARS-CoV-2
- Patients who present mild symptoms typical of COVID-19 and who have less than three days of evolution
- Patients who have cognitive and motor skills to perform mouthwash correctly.
- Patients who understand and speak Spanish
Key exclusion criteria (6 listed)
- Patients with hospitalization criteria (moderate or severe symptoms)
- Vulnerable populations such as pregnant, lactating,
- Patients with recent medical diagnosis (≤ 1 month) of pneumonia
- Patients with hyposialia
- Patients with consumption of oral antiseptics (in the form of mouthwash containing CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with CPC during the last month.
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 |
|---|---|---|
| ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDEone mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds | Other | Cetylpyridinium Chloride (CPC) 0,07% |
| PLACEBOone mouthwash containing distilled (placebo) water for 60 seconds | Other | Placebo: Distilled water with the same flavor and coloring as the product to be evaluated |
Primary outcome
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples
Time frame: 3 months
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes
SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
Time frame: 3 months
Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA
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 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE in people with COVID-19 and SARS-CoV-2 Infection, run by Rosa Tarrago at 1 site 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 6 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 7 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 1 site 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?
Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples (time frame: 3 months). 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 7 Jul 2021.