Nasal and Oral Hygiene for COVID-19

(SNOW Trial)

Recruiting at 1 trial location

Overseen By Omrana Pasha-Razzak, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Monoclonal antibodies, Molnupiravir

Disqualifiers: Nasal surgery, Non-English, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 days

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Adults (aged 18-65 years) recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, investigators are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load among adults.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Listerine Antiseptic for COVID-19?

Research suggests that using Listerine as a mouthwash can potentially reduce the amount of the COVID-19 virus in the mouth for up to two hours, which might help lower the risk of spreading the virus. ^{1 2 3 4 5}

Is the nasal and oral hygiene treatment for COVID-19 safe for humans?

The studies on mouthwashes like Listerine, chlorhexidine gluconate, and povidone iodine suggest they are generally safe for short-term use in humans, with no significant adverse effects reported. Additionally, a trial using neutral electrolyzed water for nasal and oral rinses in healthcare workers showed no adverse effects, indicating it may be a safe option. ^{3 6 7 8 9}

How does the SNOW Trial treatment differ from other COVID-19 treatments?

The SNOW Trial treatment, involving Listerine Antiseptic, is unique because it focuses on nasal and oral hygiene to reduce the viral load of SARS-CoV-2, the virus causing COVID-19, in the mouth and throat. This approach is different from other treatments that typically target the virus systemically or through vaccination, as it aims to decrease transmission risk by lowering the amount of virus present in respiratory fluids. ^{3 4 6 10 11}

Research Team

Rena Kass, MD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

This trial is for adults aged 18-65 who have tested positive for COVID-19 within the past 5 days, whether they show symptoms or not. They must be able to use an app for study data and speak English. Excluded are those with nasal surgery history, current pregnancy, previous COVID treatments like monoclonal antibodies or molnupiravir, and those unable to tolerate nasal or oral washes.

Inclusion Criteria

I have or have not had symptoms from COVID-19.

I am between 18 and 65 years old.

Currently in isolation

Exclusion Criteria

I have received a COVID vaccine booster.

You have used nasal or oral washes after getting tested for SARS-CoV-2.

Adults who do not give informed consent for study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic®

4 days

Daily visits (in-person or virtual)

Follow-up

Participants are monitored for changes in viral load and compliance with the intervention

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• SNOW Trial

Trial Overview The SNOW Trial is testing if a combination of nasal washes with baby shampoo solution and mouth gargles with Listerine can reduce the viral load in people infected with SARS-CoV-2 more effectively than using saline solutions alone.

Participant Groups

Group I: Combination of Baby Shampoo Nasal Wash and Listerine Gargle Experimental Treatment 1 Intervention

Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution

Group II: Listerine Gargle Active Control 1 Intervention

Nasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution

Group III: Baby Shampoo Nasal Wash Active Control 1 Intervention

Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution

Group IV: Saline Wash and Gargles Placebo Group 1 Intervention

Nasal washes with buffered saline solution and oropharyngeal gargles with saline solution

SNOW Trial is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Listerine Antiseptic for:

• Bad breath
• Plaque
• Gingivitis

Approved in United States as Listerine Antiseptic for:

• Bad breath
• Plaque
• Gingivitis

Approved in Canada as Listerine Antiseptic for:

• Bad breath
• Plaque
• Gingivitis

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

AXIOM Real Time Metrics

Collaborator

Trials

4

Recruited

750+

Analytica Ventures LLC

Collaborator

Trials

1

Recruited

200+

Findings from Research

In a randomized placebo-controlled study involving 200 patients suspected of having COVID-19, the intranasal and oropharyngeal delivery of a povidone-iodine and glycyrrhizic acid compound significantly accelerated recovery from SARS-CoV-2, with a notable increase in PCR-negative patients by day 10 (70% in treatment vs. 10% in placebo).

The treatment also led to faster recovery of symptoms such as anosmia and ageusia, with a reduction in virus transmission among household contacts (4% in treatment vs. 76% in placebo), highlighting its potential role in controlling COVID-19 outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Nasal, Oropharyngeal Povidone Iodine Plus Glycyrrhizic Acid Sprays, Accelerate Clinical and Laboratory Recovery and Reduces Household Transmission of SARS-CoV-2: A Randomized Placebo-Controlled Clinical Trial. Elsersy, HE., Zahran, MAH., Elbakry, AE., et al.[2022]

Nasal saline irrigation (SI) has been shown to reduce SARS-CoV-2 levels in the nasopharynx and speed up viral clearance, suggesting it could be an effective adjunctive treatment for COVID-19.

Patients using SI reported significant symptom relief and a lower risk of hospitalization, with no reported harm, making it a safe and inexpensive hygiene measure to complement other COVID-19 prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation and gargling in COVID-19: a multidisciplinary review of effects on viral load, mucosal dynamics, and patient outcomes. Huijghebaert, S., Parviz, S., Rabago, D., et al.[2023]

In a study involving 32 SARS-CoV-2-positive subjects, rinsing with Listerine or chlorhexidine gluconate significantly increased the cycle threshold (Ct) values in saliva, indicating a reduction in viral load for up to two hours post-rinse.

The results suggest that using these mouthwashes could serve as a safe and economical precaution to help reduce the transmission of SARS-CoV-2 in clinical settings, although the study's limited sample size calls for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of SARS-CoV-2 salivary viral load with pre-procedural mouth rinses: a randomised, controlled, clinical trial. Farmaha, JK., James, JN., Frazier, K., et al.[2023]

A clinical trial involving 84 participants tested the efficacy of four different mouthwashes (cetylpyridinium chloride, chlorhexidine, povidone-iodine, and hydrogen peroxide) in reducing salivary viral load of SARS-CoV-2, but found no significant changes in viral load after using these mouthwashes.

Despite previous in vitro evidence suggesting that these mouthwashes have virucidal effects, the study indicates they may not be effective in vivo for reducing viral load in COVID-19 patients, highlighting the need for further research on viral infectivity post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of antiseptic mouth rinses to reduce salivary load of SARS-CoV-2. Ferrer, MD., Barrueco, ÁS., Martinez-Beneyto, Y., et al.[2022]

In a study of 63 COVID-19 positive individuals, using oral antiseptic mouthwashes did not significantly reduce salivary viral load compared to a control group using sterile water.

However, a notable reduction in SARS-CoV-2 copies was observed 30 minutes after using a 1.5% hydrogen peroxide solution and immediately after using a 0.1% sodium hypochlorite solution, suggesting some potential for these mouthwashes in reducing viral load, though not significantly compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the viral load of SARS-CoV-2 in the saliva of patients with COVID-19. Guimarães, TC., Marques, BBF., Castro, MV., et al.[2022]

In a randomized trial involving 118 patients with SARS-CoV-2, the use of a 0.07% cetylpyridinium chloride (CPC) mouthwash did not significantly reduce the viral load in saliva compared to a placebo.

However, the CPC mouthwash was associated with significantly higher levels of SARS-CoV-2 nucleocapsid protein in saliva, suggesting it may enhance the disruption of viral particles, which could have implications for reducing transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial. Alemany, A., Perez-Zsolt, D., Raïch-Regué, D., et al.[2022]

In a randomized controlled trial involving patients with confirmed COVID-19, povidone iodine mouth rinse demonstrated a significant short-term reduction in salivary viral load compared to other mouth rinses and saline, indicating its potential effectiveness against SARS-CoV-2.

While all mouth rinses combined showed a decrease in viral load, no statistically significant differences were found between the different types of mouth rinses, suggesting that further long-term studies are needed to fully understand their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Natto, ZS., Bakhrebah, MA., Afeef, M., et al.[2022]

In a randomized control trial involving 36 COVID-19 patients, the use of cetylpyridinium chloride (CPC) and povidone-iodine (PI) mouth rinses significantly reduced salivary SARS-CoV-2 viral load at 5 minutes and 6 hours post-application compared to water.

The study suggests that CPC and PI mouth rinses could be effective as pre-procedural rinses in dental settings to help minimize the risk of COVID-19 transmission, with effects lasting up to 6 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: randomized control trial in Singapore. Seneviratne, CJ., Balan, P., Ko, KKK., et al.[2022]

A clinical trial involving 170 front-line medical staff showed that using nasopharyngeal and oropharyngeal rinses with neutral electrolyzed water (SES) significantly reduced the incidence of COVID-19, with only 1.2% of the SES group contracting the virus compared to 12.7% in the control group.

The SES rinses provided over 90% protection against developing COVID-19 without any reported adverse effects, suggesting they could be a valuable additional preventive measure for healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasopharyngeal and oropharyngeal rinses with neutral electrolyzed water prevents COVID-19 in front-line health professionals: A randomized, open-label, controlled trial in a general hospital in Mexico City. Gutiérrez-García, R., De La Cerda-Ángeles, JC., Cabrera-Licona, A., et al.[2022]

A clinical trial involving 32 SARS-CoV-2-positive patients demonstrated that 0.5% povidone-iodine (PvP-I) nasal drops and oral gargles can reduce viral loads in the nasopharynx and oropharynx, with a borderline statistically significant change in viral detection (P = 0.042).

The 0.5% PvP-I solution was well tolerated by patients, with no reported side effects, suggesting it is a safe option for reducing viral loads in COVID-19 patients, particularly in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 0.5% povidone-iodine on the nasopharyngeal and oropharyngeal viral loads in patients with COVID-19: A double-blind placebo-controlled randomized clinical trial. Sharma, P., Singh, A., Singh, NP., et al.[2023]

Common antiseptics like povidone-iodine, Listerine®, iota-carrageenan, and chlorhexidine have shown potential in reducing SARS-CoV-2 viral load significantly (by 3-4 log10) within 15-30 seconds in laboratory tests, suggesting their efficacy as antiviral agents.

Clinical trials are underway to evaluate these antiseptics for preventing virus transmission, providing prophylaxis after exposure, and reducing viral load early in infection, highlighting their potential role in managing COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the use of nasal and oral antiseptics during a global pandemic. Stathis, C., Victoria, N., Loomis, K., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Combined Nasal, Oropharyngeal Povidone Iodine Plus Glycyrrhizic Acid Sprays, Accelerate Clinical and Laboratory Recovery and Reduces Household Transmission of SARS-CoV-2: A Randomized Placebo-Controlled Clinical Trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation and gargling in COVID-19: a multidisciplinary review of effects on viral load, mucosal dynamics, and patient outcomes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Reduction of SARS-CoV-2 salivary viral load with pre-procedural mouth rinses: a randomised, controlled, clinical trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of antiseptic mouth rinses to reduce salivary load of SARS-CoV-2. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Reducing the viral load of SARS-CoV-2 in the saliva of patients with COVID-19. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cetylpyridinium Chloride Mouthwash to Reduce Shedding of Infectious SARS-CoV-2: A Double-Blind Randomized Clinical Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: randomized control trial in Singapore. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nasopharyngeal and oropharyngeal rinses with neutral electrolyzed water prevents COVID-19 in front-line health professionals: A randomized, open-label, controlled trial in a general hospital in Mexico City. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Effect of 0.5% povidone-iodine on the nasopharyngeal and oropharyngeal viral loads in patients with COVID-19: A double-blind placebo-controlled randomized clinical trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Review of the use of nasal and oral antiseptics during a global pandemic. [2021]