Nasal and Oral Hygiene for COVID-19

(SNOW Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nasal washes with baby shampoo and gargling with Listerine (an antiseptic mouthwash) can reduce the COVID-19 virus in the nose and mouth. The goal is to determine if this method is more effective than regular saline solutions for nasal and oral hygiene. Participants will be divided into groups to try different combinations of these treatments. The trial seeks adults who tested positive for COVID-19 for the first time within the last five days and are currently isolating. As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking COVID-19 treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using Listerine Antiseptic® as a mouthwash is generally safe for short-term use in people. It helps fight many germs in the mouth, but it has not been proven to kill the virus that causes COVID-19. Some studies have examined a 1% baby shampoo solution for nasal washes, finding it safe and capable of deactivating the coronavirus in certain situations.

When used together, baby shampoo nasal washes and Listerine gargles are considered safe and well-tolerated. No major reports of harmful effects have emerged when used for a short time. Both products are commonly used and have a history of safety for their intended purposes. However, more research is needed to understand their exact effect on reducing the COVID-19 virus in the body.

In summary, current research suggests that both treatments are safe and well-tolerated by most people. However, further studies are necessary to determine their effectiveness against COVID-19. Participants can feel confident about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these hygiene treatments for COVID-19 because they focus on simple, accessible methods of reducing viral load in the nasal and oral cavities. Unlike standard antiviral medications that target the virus throughout the body, these treatments use everyday products like Listerine Antiseptic® and baby shampoo for nasal and oral hygiene. This approach is different as it leverages the antiseptic properties of Listerine® and the mild cleansing of baby shampoo to potentially decrease viral transmission and severity of symptoms. These treatments offer a non-invasive, easy-to-implement strategy that could complement existing COVID-19 treatments, providing an additional layer of defense against the virus.

What evidence suggests that this trial's treatments could be effective for reducing SARS-CoV-2 viral load?

Research has shown that using Listerine Antiseptic as a mouthwash can reduce the amount of COVID-19 virus in the mouth. One study found it might lower virus levels for up to two hours. In this trial, participants will be assigned to different treatment arms. One arm involves using Listerine Antiseptic for gargles. Another arm combines baby shampoo nasal washes with Listerine gargles, which showed promise in lab tests for reducing the virus. Additionally, baby shampoo nasal washes alone might help decrease the virus in the nose, although results can vary. These findings suggest these treatments could help manage virus levels in infected individuals. ^{1 3 5 6 7}

Who Is on the Research Team?

Rena Kass, MD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

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.

Currently in isolation

You tested positive for COVID-19 for the first time within 5 days before joining the study.

Exclusion Criteria

I have received a COVID vaccine booster.

Adults who do not give informed consent for study participation

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04347538

Impact of Nasal Saline Irrigations on Viral Load in Patients ... It is our hypothesis that nasal saline or nasal saline with baby shampoo irrigations may decrease viral shedding/viral load and viral transmission, secondary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8132247/

Pharmacokinetic-based failure of a detergent virucidal for ... Johnson and Johnson's Baby Shampoo (J&J) was tested as a topical virucidal agent in SARS-CoV-2 infected subjects.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lary.31761

Washing Illness Away: A Systematic Review of the Impact ... We conducted a systematic review to analyze the efficacy of three common nasal irrigation methods, saline, PVP-I, and INCS at reducing ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35040594/

A preclinical study and randomized controlled trial - PubMed The purpose of this study was to assess both the in vivo and in vitro efficacy of a detergent-based virucidal agent, Johnson and Johnson's Baby Shampoo (J&J), ...

5. clinicaltrial.be clinicaltrial.be/fr/details/46277?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral ... Investigators have demonstrated the in vitro viridical efficacy of both Listerine Antiseptic® and 1% dilute baby shampoo solution, ...

6. advancedsinusandallergy.com advancedsinusandallergy.com/blog/can-snorting-baby-shampoo-as-a-nasal-rinse-prevent-covid

Can snorting baby shampoo as a nasal rinse prevent Covid? The results, published in the September 2020 Journal of Medical Virology, show that a 1% solution of baby shampoo deactivated 99.9% of this coronavirus after a ...

7. trialstoday.org trialstoday.org/trial/NCT04802408

SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral ... 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 ...