SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial

NCT04802408 | Active Not Recruiting Phase 2

• 1 other identifier: STUDY00016947
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Covid19; SARS-CoV Infection

Keywords

Covid 19; SARS-CoV-2; Viral Load; Nasal Rinse; Oral Rinse

Outcome Measures

Primary Outcomes (1)

• Viral Load Change from baseline

  Primary Study Endpoints The primary endpoint is the change from baseline in measured viral load in the nose and mouth of adults aged 18-65 years with SARS-CoV-2 infection after 4 days of washes (Day 5 vs Day 1). This will be measured using quantitative PCR (qPCR) analysis, with standard procedures to make cDNA copies of the viral genomic RNA and using CDC recommended primers qPCR to determine viral load. Four separate regimens will be evaluated: 1% dilute baby shampoo nasal wash and a saline oral gargle; buffered saline nasal wash and Listerine oral gargle; 1% dilute baby shampoo nasal wash and Listerine oral gargle; and buffered saline nasal wash and saline oral gargle.

  5 days

Secondary Outcomes (7)

• 4-day trend in viral load change

  5 days

• Levels of live virus (viral infectivity titer)

  15 minutes

• Levels of live virus (viral infectivity titer)

  1 day

• The tolerability of the intervention measured using the validated Sino-nasal outcome test (SNOT-22) scale.

  5 days

• Compliance as measured by percent of expected washes completed

  5 days

Study Arms (4)

Baby Shampoo Nasal Wash

ACTIVE COMPARATOR

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

Combination Product: Shampoo and saline

Listerine Gargle

ACTIVE COMPARATOR

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

Combination Product: Saline and Listerine

Combination of Baby Shampoo Nasal Wash and Listerine Gargle

EXPERIMENTAL

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

Combination Product: Shampoo and Listerine

Saline Wash and Gargles

PLACEBO COMPARATOR

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

Combination Product: Saline and Saline

Interventions

Shampoo and saline COMBINATION_PRODUCT

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

Baby Shampoo Nasal Wash

Saline and Listerine COMBINATION_PRODUCT

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

Listerine Gargle

Shampoo and Listerine COMBINATION_PRODUCT

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

Combination of Baby Shampoo Nasal Wash and Listerine Gargle

Saline and Saline COMBINATION_PRODUCT

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

Saline Wash and Gargles

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A first-time positive test for SARS-CoV-2 infection within 5 days of enrollment
• Adults who are ≥18 -65 years of age
• Currently in isolation
• Symptomatic or asymptomatic from SARS-CoV-2

You may not qualify if:

• History of nasal or sinus surgery
• Non-English speaking
• Lack of electronic device (computer, mobile phone etc.) on which to access an app for study data collection.
• Adults that need inpatient care for COVID-19 or any of its complications.
• Adults that give a history of being unable to tolerate gargles or nasal washes.
• Adults who do not give informed consent for study participation.
• History of a Covid vaccine booster
• A history of use of nasal or oral washes after SARS-CoV-2 test sample collection.
• Prisoners
• Adults that give history of current pregnancy (NO KNOWN CONTRAINDICATION TO PREGNANCY)
• History of monoclonal antibody treatment
• History of or current molnupiravir treatment

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• AXIOM Real Time Metrics: collaborator
• Analytica Ventures LLC: collaborator

Study Sites (2)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn State

State College, Pennsylvania, 16801, United States

Location

Related Publications (6)

• Meister TL, Bruggemann Y, Todt D, Conzelmann C, Muller JA, Gross R, Munch J, Krawczyk A, Steinmann J, Steinmann J, Pfaender S, Steinmann E. Virucidal Efficacy of Different Oral Rinses Against Severe Acute Respiratory Syndrome Coronavirus 2. J Infect Dis. 2020 Sep 14;222(8):1289-1292. doi: 10.1093/infdis/jiaa471.

  PMID: 32726430 BACKGROUND

• Sungnak W, Huang N, Becavin C, Berg M, Queen R, Litvinukova M, Talavera-Lopez C, Maatz H, Reichart D, Sampaziotis F, Worlock KB, Yoshida M, Barnes JL; HCA Lung Biological Network. SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nat Med. 2020 May;26(5):681-687. doi: 10.1038/s41591-020-0868-6. Epub 2020 Apr 23.

  PMID: 32327758 BACKGROUND

• Shrestha NK, Marco Canosa F, Nowacki AS, Procop GW, Vogel S, Fraser TG, Erzurum SC, Terpeluk P, Gordon SM. Distribution of Transmission Potential During Nonsevere COVID-19 Illness. Clin Infect Dis. 2020 Dec 31;71(11):2927-2932. doi: 10.1093/cid/ciaa886.

  PMID: 32594116 BACKGROUND

• Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021 Jan;2(1):e13-e22. doi: 10.1016/S2666-5247(20)30172-5. Epub 2020 Nov 19.

  PMID: 33521734 BACKGROUND

• Mohamed N. Early viral clearance among Covid-19 patients when gargling with povidone-iodine and essential oils: A pilot clinical trial. medRxiv 2020.09.07.20180448; https://doi.org/10.1101/2020.09.07.20180448 preprint

  BACKGROUND

• "Tracking the Coronavirus at U.S. Colleges and Universities." New York Times. Last updated Dec. 11, 2020.

  BACKGROUND

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Sodium Chloride; Listerine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rena Kass, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We plan to provide the number and proportion of the primary outcome of participants who have completed 5 days of follow up from randomization, by treatment arms to an independent biostatistician, as well as participant accrual rate, and withdrawals from study. A formal interim analysis (as detailed in the analysis section) will be completed when 67% of final sample size reaches day 5 and the results will be provided masked to the independent biostatistician, who will decide whether to halt the trial or not.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Model Details: This is a prospective, randomized, controlled, 2x2 factorial, phase 2/phase 3 trial to compare the impact of a 4-day intervention of nasal washes with 1% baby shampoo solution and/or oropharyngeal gargles with Listerine Antiseptic® solution compared to that of nasal washes with buffered saline solution and/or oropharyngeal rinses with saline solution on naso-oropharyngeal SARS-CoV-2 viral load in a population of adults (aged 18-65 years) with SARS-CoV-2 infection diagnosed within 5 days who are asymptomatic or mildly symptomatic for COVID-19 disease.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 17, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)