Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes

Covid19 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902976
• Other study ID #: 4560-21
• Status: Completed
• Phase: N/A
• Start date: April 4, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: April 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• CPC+ZN
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
• CPC
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 Control
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.

Locations

Country	Name	City	State
Brazil	Hospital israelita Albert Einstein	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Colgate Palmolive

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour