The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients

Sponsor
King Abdulaziz University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04941131
Collaborator
(none)
60
1
4
8
7.5

Study Details

Study Description

Brief Summary

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection . It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

Condition or Disease Intervention/Treatment Phase
  • Drug: Chlorhexidine digluconate, povidone iodine
Phase 4

Detailed Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is one of the coronaviruses such as (SARS & MERS) which are commonly known for causing severe respiratory illnesses. SARS-CoV-2 is considered to be the leading cause of coronavirus disease (COVID-19) . On March 11th 2020, the WHO announced that SARS-CoV-2 is a global pandemic. Based on COVID-19 Saudi Arabia Ministry of Health Dashboard, globally, as of April 5th 2021, there have been more than 131 million confirmed cases of the disease including more than 2 million deaths. Nationally, as of April 5th 2021, there have been 392,682 confirmed cases including 6,697 deaths .

The diagnosis of COVID-19 involves molecular testing which is the gold standard and the WHO most recommended method of diagnosis. SARS-CoV-2 seemed to be very contagious and the chances of its transmission even before any symptoms occur are very high. It has been documented that COVID-19 disease incubation period to range between 1-14 days, most reported to be between 3 to 7 days with some evidence suggested the incubation period of 5 days. Evidence concerned about the spread of infection due to missed screened cases especially when individuals are unaware of their infection status and didn't show any symptoms yet.

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2 . Multiple studies suggested SARS-CoV-2 to be airborne infection, and get transmitted through aerosols. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection. It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

The aim of our study is to determine the efficacy of different mouthwash in reducing the SARS-CoV-2 viral load in saliva of COVID-19 confirmed cases compared with tap water.

The objectives of the study are to determine the viral load, assess the cases clinical information & disease manifestation, plus the cases demographic characteristics believed to have an influence on the disease characteristics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients: A Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: chlorhexidine digluconate mouthwash

Drug: Chlorhexidine digluconate, povidone iodine
This is a mouth wash that can be used over the counter.

Experimental: chlorhexidine digluconate lozenges

Drug: Chlorhexidine digluconate, povidone iodine
This is a mouth wash that can be used over the counter.

Experimental: povidone iodine mouthwash

Drug: Chlorhexidine digluconate, povidone iodine
This is a mouth wash that can be used over the counter.

No Intervention: tap water

Outcome Measures

Primary Outcome Measures

  1. quantity of the virus in the saliva measured by Q- PCR [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • A history of positive nasal swabs for SARS-CoV-2 based on reverse-transcription polymerase chain reaction (RT-PCR) assays.
Exclusion Criteria:
  • History of allergy to any of the products that will be used

  • known pregnancy

  • Renal failure

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Abdulaziz University , Faculty of Dentistry Jeddah Saudi Arabia

Sponsors and Collaborators

  • King Abdulaziz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zuhair Saleh Natto, Head of research unit and associate professor, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT04941131
Other Study ID Numbers:
  • 1485
First Posted:
Jun 28, 2021
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Zuhair Saleh Natto, Head of research unit and associate professor, King Abdulaziz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2021