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Nasal and Oral Hygiene for COVID-19 (SNOW Trial)
Phase 2 & 3
Recruiting
Led By Rena Kass, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults who are ≥18 -65 years of age
Symptomatic or asymptomatic from SARS-CoV-2
Must not have
History of monoclonal antibody treatment
History of or current molnupiravir treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Summary
This trial is testing whether a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic can reduce the SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the nasal and oral wash procedures. There could also be reactions specific to the ingredients in baby shampoo and Listerine such as irritation or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have or have not had symptoms from COVID-19.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with monoclonal antibodies before.
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I have been treated with or am currently on molnupiravir.
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I am hospitalized due to COVID-19 or its complications.
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I have had surgery on my nose or sinuses.
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I do not speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Viral Load Change from baseline
Secondary study objectives
4-day trend in viral load change
Acceptability of the intervention as measured by 7 item questionnaire based an acceptability framework described by Sekhon (2017)
Compliance as measured by percent of expected washes completed
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Combination of Baby Shampoo Nasal Wash and Listerine GargleExperimental Treatment1 Intervention
Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution
Group II: Listerine GargleActive Control1 Intervention
Nasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution
Group III: Baby Shampoo Nasal WashActive Control1 Intervention
Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution
Group IV: Saline Wash and GarglesPlacebo Group1 Intervention
Nasal washes with buffered saline solution and oropharyngeal gargles with saline solution
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Who is running the clinical trial?
AXIOM Real Time MetricsUNKNOWN
3 Previous Clinical Trials
552 Total Patients Enrolled
Analytica Ventures LLCUNKNOWN
Milton S. Hershey Medical CenterLead Sponsor
511 Previous Clinical Trials
2,870,690 Total Patients Enrolled
Rena Kass, MDPrincipal InvestigatorPenn State College of Medicine