Effect of Hypertonic Saturated Saline Mouth Rinse on Covid-19 Virus in Vivo.

NCT ID: NCT04842721

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-12-31

Brief Summary

Sars-Cov2 virus is transmitted through the respiratory route and by direct contact with contaminated surfaces and subsequent contact with nasal, oral or ocular mucosa. Many studies have found that the oral cavity and specifically the saliva may be a high-risk route for SARS-CoV-2 infection. Thus, strategies reducing salivary viral load could contribute to reduce the risk of transmission. Furthermore, studies have shown that SARS-CoV persists for two days in oral mucous membranes before its diffusion to the lower respiratory tract. This offers an interesting preventive and therapeutic window of opportunity for the control of this disease. In addition, Naso-pharyngeal viral load was linked with lung disease severity in a study of 12 patients with pneumonia.**. Some current studies around the world, as listed on ClinicalTrials.gov, are testing the effect of some common mouth rinses/gargles on the Covid-19 viral load, including Chlorhexidine gluconate, Hydrogen peroxide Povidone Iodine, Saline (1.102% w/v, slightly hypertonic) and Alcohol.

This study aims to test whether Prolonged Hypertonic Saline Mouth Rinse would reduce/eliminate*** the viral load in the Oro- Naso-Pharyngeal cavity, and could therefore be used as a strategy to reduce transmission risk in clinical and social settings.

The investigator hypothesizes that COVID-19-positive participants who use Hypertonic Saline Prolonged Rinse treatment will have an reduction/elimination of their Covid viral load, will develop a negative Covid test 7 days after intervention completion and will improve their clinical symptoms, potentially reducing lung disease severity.

Detailed Description

The aim of this study is to determine if prolonged rinsing (30 minutes) of mouth without gargling using a Hypertonic Saturated Sodium Chloride solution would reduce/eliminate the Upper Respiratory viral load in Covid-19 infected patients compared to a placebo (Plain Water Rinse). Patients who have been tested positive for COVID-19 using Nucleic Acid Test via Nose or Throat Swabs within 7 days prior to the start of the trial will be instructed to use either of the two treatment arms (Active or Placebo) for 30 minutes twice daily for two days and retested for Covid 7 days after the last treatment

A randomized blinded controlled study, whereas a number of patients (at least 20) with clinically-confirmed Covid-19 infection within 7 days prior to the start of the study, are equally divided into 2 groups, Active and Control groups, using Active and Control Mouth rinses respectively. The Active Rinse is a 25 ml of Hypertonic Saturated Saline solution made by mixing 10 grams of Sodium Chloride (Table Salt) in 25 ml of Tap water with some salt crystals deposited. The Control Rinse is a 25 ml of Plain Tap Water. Each Patient of both groups will be asked to keep the solution still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the solution will be spit out and mouth will be rinsed with plain water several times. The process will be done twice a day for 2 days. Patients of both groups will be tested once for Covid-19 7 days after the last treatment.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypertonic Saturated Saline Mouth Rinse Active Arm

The Active Rinse is a 25 ml of Hypertonic Saturated Saline solution made by mixing 10 grams of Sodium Chloride (Table Salt) in 25 ml of Tap water with some salt crystals deposited.

Group Type: ACTIVE_COMPARATOR

Hypertonic Saturated Saline Mouth Rinse Active Arm

Intervention Type: DRUG

Each Patient of this groups will be asked to keep the solution still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the solution will be spit out and mouth will be rinsed with plain water several times. The process will be done twice a day for 2 days.

Plain Water Control Arm

The Control Rinse is a 25 ml of Plain Tap Water.

Group Type: PLACEBO_COMPARATOR

Placebo Plain Water Mouth Rinse Arm

Intervention Type: OTHER

Each Patient of this groups will be asked to keep the water still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the water will be spit out. The process will be done twice a day for 2 days.

Interventions

Hypertonic Saturated Saline Mouth Rinse Active Arm

Each Patient of this groups will be asked to keep the solution still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the solution will be spit out and mouth will be rinsed with plain water several times. The process will be done twice a day for 2 days.

Intervention Type: DRUG

Placebo Plain Water Mouth Rinse Arm

Each Patient of this groups will be asked to keep the water still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the water will be spit out. The process will be done twice a day for 2 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Tested positive for Covid in the past 7 days
• Have the ability to perform mouth rinse twice daily for 2 days and to undergo Covid testing by Oro or Naso-Pharyngeal swabs.
• No need for a ventilator for oxygenation support
• Can understand and read English
• Lives in Alberta Canada

Exclusion Criteria

• Requiring mechanical ventilation
• Unable to perform mouth rinses twice times daily for 2 days
• Patients that are tested negative for COVID-19
• Patients who have been eating or drinking within an hour before or after each session
• Use of an antiseptic mouthwash within 7 days prior or after the study
• Patient who are intubated or too sick to give consent for the study.
• Not able to speak in English or lacking the decision-making capacity to consent for study.
• Inability to comply with protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rafik Batroussy

OTHER

Sponsor Role: lead

Responsible Party

Rafik Batroussy

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rafik Batroussy, BSc.Pharm.

Role: PRINCIPAL_INVESTIGATOR

Independent

Locations

Rafik Batroussy

Calgary, Alberta, Canada

Countries

Canada

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7582358/

Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2

https://www.cnn.com/2020/11/03/health/covid-test-negative-contagious-wellness/index.html

Viral load under detectable levels can result in a False Negative PCR Covid test

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id