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

STUDY00016947

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.

2021-10-01

2025-05-30

2025-05-30

Recruiting

Early phase I

200

Inclusion Criteria: 1. A first-time positive test for SARS-CoV-2 infection within 5 days of enrollment 2. Adults who are ≥18 -65 years of age 3. Currently in isolation 4. Symptomatic or asymptomatic from SARS-CoV-2 Exclusion Criteria: 1. History of nasal or sinus surgery 2. Non-English speaking 3. Lack of electronic device (computer, mobile phone etc.) on which to access an app for study data collection. 4. Adults that need inpatient care for COVID-19 or any of its complications. 5. Adults that give a history of being unable to tolerate gargles or nasal washes. 6. Adults who do not give informed consent for study participation. 7. History of a Covid vaccine booster 8. A history of use of nasal or oral washes after SARS-CoV-2 test sample collection. 9. Prisoners 10. Adults that give history of current pregnancy (NO KNOWN CONTRAINDICATION TO PREGNANCY) 11. History of monoclonal antibody treatment 12. History of or current molnupiravir treatment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-09-07