The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Chlorhexidine digluconate, povidone iodine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Mouth Wash, Viral Load
Eligibility Criteria
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
Sites / Locations
- King Abdulaziz University , Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
chlorhexidine digluconate mouthwash
chlorhexidine digluconate lozenges
povidone iodine mouthwash
tap water
Arm Description
Outcomes
Primary Outcome Measures
quantity of the virus in the saliva measured by Q- PCR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04941131
Brief Title
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients
Official Title
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
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
5. 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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Mouth Wash, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chlorhexidine digluconate mouthwash
Arm Type
Experimental
Arm Title
chlorhexidine digluconate lozenges
Arm Type
Experimental
Arm Title
povidone iodine mouthwash
Arm Type
Experimental
Arm Title
tap water
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine digluconate, povidone iodine
Intervention Description
This is a mouth wash that can be used over the counter.
Primary Outcome Measure Information:
Title
quantity of the virus in the saliva measured by Q- PCR
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
King Abdulaziz University , Faculty of Dentistry
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35905275
Citation
Natto ZS, Bakhrebah MA, Afeef M, Al-Harbi S, Nassar MS, Alhetheel AF, Ashi H. The short-term effect of different chlorhexidine forms versus povidone iodine mouth rinse in minimizing the oral SARS-CoV-2 viral load: An open label randomized controlled clinical trial study. Medicine (Baltimore). 2022 Jul 29;101(30):e28925. doi: 10.1097/MD.0000000000028925.
Results Reference
derived
Learn more about this trial
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients
We'll reach out to this number within 24 hrs