Back to results

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

About this trial

This is an interventional supportive care trial for Covid19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

We'll reach out to this number within 24 hrs