Covid19NCT04902976
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
A study testing CPC+ZN and CPC in people with Covid19, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
The aim of this study is to analyze the efficacy of oral disinfection with 0.075% Cetylpyridinium Chloride alone and 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate in reduction of the viral load of SARS-CoV-2 in the oral cavity. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- CPC+ZN and CPC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2021to 30 Oct 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive for SARS-CoV-2 by the RT-PCR method,
- in common bed for minimum of 1 day and maximum of 5 days,
- ensuring that patients are no more than 10 days since showing the first symptoms,
- who are positive for SARS-CoV-2 in the first collection of oral fluid and saliva, and
- who demands oral hygiene care and other preventive and therapeutic dental procedures.
Who cannot join
- pediatric patients, t
- hose who tested negative for SARS-CoV-2 by the RT-PCR method at the time of recruitment or at the time of first oral fluid and saliva collection;
- those who exhibit oral ulcerations and other erosive lesions in the oral mucosa, which contraindicate the use of cetylpyridinium;
- patients who have bleeding in the oral cavity which prevents sample collections; patients who report history of allergy, irritations or other side effects derived from the use of these substances;
- patients who do not adhere to oral care protocols or those in whom it was not possible to perform these procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Viral Load of SARS-COV-2 Virus in the Oral Cavity After Rinsing With Oral Antimicrobial Mouthwashes in Patients Covid-19.
The aim of this study is to analyze the efficacy of oral disinfection with 0.075% Cetylpyridinium Chloride alone and 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate in reduction of the viral load of SARS-CoV-2 in the oral cavity. Patients of both sexes, in the age-range between 18 and 90 years, diagnosed positive for SARS-CoV-2 by the RT-PCR method, and who demand oral hygiene care and other preventive and therapeutic dental procedures, will be included in this randomized clinical study.The study will comprise patients hospitalized in common beds, without mechanical ventilation - who will be divided into three groups. Some of these protocols with the use of antimicrobial solutions are hoped to be efficient in reducing the viral load in the oral cavity. This is a factor that could contribute to reducing contamination of the environment caused by aerosols resulting from dental procedures, in addition to helping with the improvement in biosafety protocols against SARS-CoV-2.
Read the detailed description
Each group of patients will receive specific interventions, as follows: 0.075% Cetylpyridinium Chloride mouthwash (Group 1); 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate mouthwash (Group 2), negative control, distilled water (Group 3). To monitor the viral load, the following procedures will be performed: saliva collection, in time intervals before mouth rinsing with the solutions at baseline (T0), immediately after (T1), 30 min (T2), and 1 hour after mouth rinses (T3). SARS-CoV-2 will be quantified by Real Time quantitative reverse transcription polymerase chain reaction (RT-qPCR) assays.
- Conditions
- Covid19
- Being tested
- CPC+ZN, CPC, Negative Control
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC+ZNOther
In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the solution for 30 s
CPCOther
In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the proposed solution for 30 s;
Negative ControlOther
In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of distilled water for 30 s.
| Study group | Role | What they receive |
|---|---|---|
| CPC+Zn | Active comparator | patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution. Receives: Other: CPC+ZN |
| CPC | Active comparator | patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution. Receives: Other: CPC |
| Negative Control | Placebo comparator | patients submitted to mouth rinse with distilled water. Receives: Other: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SARS-COV-2 load in the oral cavity and saliva
Change of SARS-COV-2 load in the oral cavity and saliva mensuared by virus fold reduction and viral quantitation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start4 Apr 2021
- Primary completion30 May 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- luciana Correa, PhD, Study director, University of Sao PauloDebora H Douek, PhD, Study chair, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902976
- Sponsor's protocol ID
- 4560-21
- Status last verified
- Apr 2021
- First submitted
- 24 May 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Viral Load of SARS-COV-2 Virus in the Oral Cavity After Rinsing With Oral Antimicrobial Mouthwashes in Patients Covid-19.
- ClinicalTrials.gov ID
- NCT04902976
- Acronym / sponsor ID
- 4560-21
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 26 May 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.
The aim of this study is to analyze the efficacy of oral disinfection with 0.075% Cetylpyridinium Chloride alone and 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate in reduction of the viral load of SARS-CoV-2 in the oral cavity. Patients of both sexes, in the age-range between 18 and 90 years, diagnosed positive for SARS-CoV-2 by the RT-PCR method, and who demand oral hygiene care and other preventive and therapeutic dental procedures, will be included in this randomized clinical study.The study will comprise patients hospitalized in common beds, without mechanical ventilation - who will be divided into three groups. Some of these protocols with the use of antimicrobial solutions are hoped to be efficient in reducing the viral load in the oral cavity. This is a factor that could contribute to reducing contamination of the environment caused by aerosols resulting from dental procedures, in addition to helping with the improvement in biosafety protocols against SARS-CoV-2.
Detailed description
Each group of patients will receive specific interventions, as follows: 0.075% Cetylpyridinium Chloride mouthwash (Group 1); 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate mouthwash (Group 2), negative control, distilled water (Group 3). To monitor the viral load, the following procedures will be performed: saliva collection, in time intervals before mouth rinsing with the solutions at baseline (T0), immediately after (T1), 30 min (T2), and 1 hour after mouth rinses (T3). SARS-CoV-2 will be quantified by Real Time quantitative reverse transcription polymerase chain reaction (RT-qPCR) assays.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPC+Zn | Active comparator | Other: CPC+ZNpatients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution. |
| CPC | Active comparator | Other: CPCpatients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution. |
| Negative Control | Placebo comparator | Other: Negative Controlpatients submitted to mouth rinse with distilled water. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- positive for SARS-CoV-2 by the RT-PCR method,
- in common bed for minimum of 1 day and maximum of 5 days,
- ensuring that patients are no more than 10 days since showing the first symptoms,
- who are positive for SARS-CoV-2 in the first collection of oral fluid and saliva, and
- who demands oral hygiene care and other preventive and therapeutic dental procedures.
Key exclusion criteria (5 listed)
- pediatric patients, t
- hose who tested negative for SARS-CoV-2 by the RT-PCR method at the time of recruitment or at the time of first oral fluid and saliva collection;
- those who exhibit oral ulcerations and other erosive lesions in the oral mucosa, which contraindicate the use of cetylpyridinium;
- patients who have bleeding in the oral cavity which prevents sample collections; patients who report history of allergy, irritations or other side effects derived from the use of these substances;
- patients who do not adhere to oral care protocols or those in whom it was not possible to perform these procedures.
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 |
|---|---|---|
| CPC+ZNIn patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the solution for 30 s | Other | CPC+Zn |
| CPCIn patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the proposed solution for 30 s; | Other | CPC |
| Negative ControlIn patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of distilled water for 30 s. | Other | Negative Control |
Primary outcome
Change of SARS-COV-2 load in the oral cavity and saliva
Time frame: 1 hour
Change of SARS-COV-2 load in the oral cavity and saliva mensuared by virus fold reduction and viral quantitation
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 11 Mar 2022.
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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.
luciana Correa, PhD study director
University of Sao Paulo
Debora H Douek, PhD study chair
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPC+ZN and CPC in people with Covid19, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 5 inclusion and 5 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 11 Mar 2022. 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 Brazil. 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?
Change of SARS-COV-2 load in the oral cavity and saliva (time frame: 1 hour). 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 11 Mar 2022.