Covid19Phase 2NCT04842721
Effect of Hypertonic Saturated Saline Mouth Rinse on Covid-19 Virus in Vivo.
A Phase 2 study testing Hypertonic Saturated Saline Mouth Rinse Active Arm in people with Covid19, run by Rafik Batroussy at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Hypertonic Saturated Saline Mouth Rinse Active Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2021to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prolonged Mouth Rinse With Hypertonic Saturated Saline Solution on the Naso-Pharyngeal Viral Load of Covid-19 Virus in Vivo.
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.
Read the 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
- Being tested
- Hypertonic Saturated Saline Mouth Rinse Active Arm, Placebo Plain Water Mouth Rinse Arm
- Keywords
- Rinse, Mouth Rinse, Mouthwash, Mouth Wash
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saturated Saline Mouth Rinse Active ArmDrug
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.
Placebo Plain Water Mouth Rinse ArmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saturated Saline Mouth Rinse Active Arm | Active comparator | 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. Receives: Drug: Hypertonic Saturated Saline Mouth Rinse Active Arm |
| Plain Water Control Arm | Placebo comparator | The Control Rinse is a 25 ml of Plain Tap Water. Receives: Other: Placebo Plain Water Mouth Rinse Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Negative Covid PCR test results
The number of Negative PCR tests post intervention will be compared between both the Active group and the Control group. The Hypertonic Saturated Mouth Rinse intervention will be considered effective in reducing/eliminating Covid presence in the Oro-Nasopharyngeal area if the PCR Covid tests performed 7 days post termination of the study have more statistically-significant negative results in the Active group than in the Control group..
Measured: 7 days
Secondary outcomes (1)
Number of Participants with Change in Clinical Symptoms
A change in Covid Clinical symptoms (like fever, shortness of breath, dry cough, reduced lung functions, ..) in both the Active and Control groups will be monitored and statistically analyzed.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Not yet meeting Health Canada's requirements for Clinical Trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafik Batroussy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafik Batroussy, Batroussy, Rafik
- Investigators
- Rafik Batroussy, BSc.Pharm., Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842721
- Sponsor's protocol ID
- 2
- Status last verified
- Jul 2022
- First submitted
- 11 Apr 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Mouth Rinse With Hypertonic Saturated Saline Solution on the Naso-Pharyngeal Viral Load of Covid-19 Virus in Vivo.
- ClinicalTrials.gov ID
- NCT04842721
- Acronym / sponsor ID
- 2
- Conditions
- Covid19
- Keywords
- Rinse, Mouth Rinse, Mouthwash, Mouth Wash
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not yet meeting Health Canada's requirements for Clinical Trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rafik BatroussyUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Saturated Saline Mouth Rinse Active Arm | Active comparator | Drug: Hypertonic Saturated Saline Mouth Rinse Active ArmThe 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. |
| Plain Water Control Arm | Placebo comparator | Other: Placebo Plain Water Mouth Rinse ArmThe Control Rinse is a 25 ml of Plain Tap Water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic Saturated Saline Mouth Rinse Active ArmEach 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. | Drug | Hypertonic Saturated Saline Mouth Rinse Active Arm |
| Placebo Plain Water Mouth Rinse ArmEach 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. | Other | Plain Water Control Arm |
Primary outcome
Number of Participants with Negative Covid PCR test results
Time frame: 7 days
The number of Negative PCR tests post intervention will be compared between both the Active group and the Control group. The Hypertonic Saturated Mouth Rinse intervention will be considered effective in reducing/eliminating Covid presence in the Oro-Nasopharyngeal area if the PCR Covid tests performed 7 days post termination of the study have more statistically-significant negative results in the Active group than in the Control group..
1 secondary outcome
Number of Participants with Change in Clinical Symptoms
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Antiviral Activity of Reagents in Mouth Rinses against SARS-CoV-2Link provided by the sponsor.
- Viral load under detectable levels can result in a False Negative PCR Covid testLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafik Batroussy, BSc.Pharm. principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypertonic Saturated Saline Mouth Rinse Active Arm in people with Covid19, run by Rafik Batroussy at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Negative Covid PCR test results (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.