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

NCT04902976 | Completed DMC

• 1 other identifier: 4560-21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

CPC+Zn

ACTIVE COMPARATOR

patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride associated with 0.28% zinc lactate solution.

Other: CPC+ZN

CPC

ACTIVE COMPARATOR

patients submitted to mouth rinse with 0.075% Cetylpyridinium Chloride solution.

Other: CPC

Negative Control

PLACEBO COMPARATOR

patients submitted to mouth rinse with distilled water.

Other: Negative Control

Interventions

CPC+ZN OTHER

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+Zn

CPC OTHER

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;

CPC

Negative Control OTHER

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.

Negative Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Hospital israelita Albert Einstein

São Paulo, 05652-900, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

cytidylyl-(3'-5')-cytidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• luciana Correa, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Debora H Douek, PhD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 26, 2021
• Study Start: April 4, 2021
• Primary Completion: May 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 11, 2022

Record last verified: 2021-04

Locations

BR (1)