- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902976
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
February 24, 2022 updated by: Hospital Israelita Albert Einstein
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 05652-900
- Hospital Israelita Albert Einstein
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CPC+Zn
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution.
|
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
|
Active Comparator: CPC
patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution.
|
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;
|
Placebo Comparator: Negative Control
patients submitted to mouth rinse with distilled water.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: luciana Correa, PhD, University of São Paulo
- Study Chair: Debora H Douek, PhD, Hospital Israelita Albert Einstein
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2021
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
October 30, 2021
Study Registration Dates
First Submitted
May 24, 2021
First Submitted That Met QC Criteria
May 24, 2021
First Posted (Actual)
May 26, 2021
Study Record Updates
Last Update Posted (Actual)
March 11, 2022
Last Update Submitted That Met QC Criteria
February 24, 2022
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4560-21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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