Study 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.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 6 days
1 day
Levels of live virus (viral infectivity titer)
5 days
4-day trend in viral load change
Compliance as measured by percent of expected washes completed
Compliance as measured by percentage of randomized participants that withdrew consent and elected not to continue in the study.
The tolerability of the intervention measured using the validated Sino-nasal outcome test (SNOT-22) scale.
Viral Load Change from baseline
6 days
Acceptability of the intervention as measured by 7 item questionnaire based an acceptability framework described by Sekhon (2017)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Listerine Gargle
1 of 4
Baby Shampoo Nasal Wash
1 of 4
Combination of Baby Shampoo Nasal Wash and Listerine Gargle
1 of 4
Saline Wash and Gargles
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group
200 Total Participants · 4 Treatment Groups
Primary Treatment: Shampoo and Listerine · Has Placebo Group · Phase 2 & 3
Combination of Baby Shampoo Nasal Wash and Listerine Gargle
CombinationProduct
Experimental Group · 1 Intervention: Shampoo and Listerine · Intervention Types: CombinationProductListerine Gargle
CombinationProduct
ActiveComparator Group · 1 Intervention: Saline and Listerine · Intervention Types: CombinationProductSaline Wash and Gargles
CombinationProduct
PlaceboComparator Group · 1 Intervention: Saline and Saline · Intervention Types: CombinationProductBaby Shampoo Nasal Wash
CombinationProduct
ActiveComparator Group · 1 Intervention: Shampoo and saline · Intervention Types: CombinationProductTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 days
Who is running the clinical trial?
AXIOM Real Time MetricsUNKNOWN
3 Previous Clinical Trials
545 Total Patients Enrolled
Milton S. Hershey Medical CenterLead Sponsor
462 Previous Clinical Trials
2,784,527 Total Patients Enrolled
Analytica Ventures LLCUNKNOWN
Rena Kass, MDPrincipal InvestigatorPenn State College of Medicine
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:I am currently in isolation
You are an adult who is ≥18 - 65 years of age.
A person who tests positive for the SARS-CoV-2 virus within 5 days of enrolling in a study is more likely to experience a severe illness.
Symptomatic people have fever and cough
References
- Meister, Toni Luise, Yannick Brüggemann, Daniel Todt, Carina Conzelmann, Janis A Müller, Rüdiger Groß, Jan Münch, et al.. 2020. “Virucidal Efficacy of Different Oral Rinses Against Severe Acute Respiratory Syndrome Coronavirus 2”. The Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jiaa471.
- Sungnak, Waradon, HCA Lung Biological Network, Ni Huang, Christophe Bécavin, Marijn Berg, Rachel Queen, Monika Litvinukova, et al.. 2020. “Sars-cov-2 Entry Factors Are Highly Expressed in Nasal Epithelial Cells Together with Innate Immune Genes”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-0868-6.
- Shrestha, Nabin K, Francisco Marco Canosa, Amy S Nowacki, Gary W Procop, Sherilynn Vogel, Thomas G Fraser, Serpil C Erzurum, Paul Terpeluk, and Steven M Gordon. 2020. “Distribution of Transmission Potential During Nonsevere COVID-19 Illness”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciaa886.
- Cevik, Muge, Matthew Tate, Ollie Lloyd, Alberto Enrico Maraolo, Jenna Schafers, and Antonia Ho. 2021. “Sars-cov-2, Sars-cov, and Mers-cov Viral Load Dynamics, Duration of Viral Shedding, and Infectiousness: A Systematic Review and Meta-analysis”. The Lancet Microbe. Elsevier BV. doi:10.1016/s2666-5247(20)30172-5.
- "Tracking the Coronavirus at U.S. Colleges and Universities." New York Times. Last updated Dec. 11, 2020.
- 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
- 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. Erratum In: J Infect Dis. 2021 Feb 13;223(3):541.
- 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.
- Rena Kass 2021. "SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04802408.
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Cancer Related
Treatments