The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients
The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Jeddah, Saudi Arabia
- King Abdulaziz University , Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: chlorhexidine digluconate mouthwash
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This is a mouth wash that can be used over the counter.
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Experimental: chlorhexidine digluconate lozenges
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This is a mouth wash that can be used over the counter.
|
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Experimental: povidone iodine mouthwash
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This is a mouth wash that can be used over the counter.
|
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No Intervention: tap water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
E Genes
Time Frame: 6 months
|
Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples.
Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence.
Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels.
Lower Ct values indicate higher viral loads.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
S Genes
Time Frame: 6 months
|
Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples.
Since the S gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence.
Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels.
Lower Ct values indicate higher viral loads.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Anti-Infective Agents
- Dermatologic Agents
- Anti-Infective Agents, Local
- Disinfectants
- Plasma Substitutes
- Blood Substitutes
- Chlorhexidine
- Povidone
- Chlorhexidine gluconate
- Povidone-Iodine
Other Study ID Numbers
- 1485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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