Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPC+ZN
CPC
Negative Control
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital israelita Albert Einstein
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
CPC+Zn
CPC
Negative Control
Arm Description
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution.
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution.
patients submitted to mouth rinse with distilled water.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04902976
First Posted
May 24, 2021
Last Updated
February 24, 2022
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT04902976
Brief Title
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Colgate Palmolive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPC+Zn
Arm Type
Active Comparator
Arm Description
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution.
Arm Title
CPC
Arm Type
Active Comparator
Arm Description
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution.
Arm Title
Negative Control
Arm Type
Placebo Comparator
Arm Description
patients submitted to mouth rinse with distilled water.
Intervention Type
Other
Intervention Name(s)
CPC+ZN
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
CPC
Intervention Description
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;
Intervention Type
Other
Intervention Name(s)
Negative Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of SARS-COV-2 load in the oral cavity and saliva
Description
Change of SARS-COV-2 load in the oral cavity and saliva mensuared by virus fold reduction and viral quantitation
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
luciana Correa, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Debora H Douek, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
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