Covid19Phase 2/3SNOWNCT04802408
SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial
A Phase 2/3 study testing Saline and Listerine and Saline and Saline in people with Covid19 and SARS-CoV Infection, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Saline and Listerine and Saline and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2021to 30 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Penn State
State College, Pennsylvania, 16801
About this study
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.
Read the detailed description
Investigators have demonstrated the in vitro viridical efficacy of both Listerine Antiseptic® and 1% dilute baby shampoo solution, a commonly used nasal rinse, against a SARS-CoV-2 surrogate and Meister et al. have similar findings with SARS-CoV-2. With an urgent need to expand the armamentarium of widely available, low-cost interventions, that are safe for repeated human use and reduce viral transmission, investigators seek to determine the impact of a combined regimen of oral and nasal rinsing with these agents on naso-oropharyngeal viral loads in adults (aged 18-65 years) with SARS-CoV-2 infection.
Rationale for the intervention: a combination of nasal washes with 1% solution of baby shampoo and oral washes with Listerine Antiseptic® Available data indicate that SARS-CoV-2 is most likely to spread, like most other common respiratory viruses, primarily through respiratory droplet transmission. With the naso-oropharynx being both the primary site from which the virus is expelled by people with infection and the nasal and oral mucosal cells is one of the sites of initial infection and viral replication. Specifically the ACE2 receptor, that SARS-CoV-2 binds for cell entry, are highly concentrated in the goblet and ciliated cells of the nose and on the tongue. Thus a reduction of viral load through topical treatment of these sites could potentially lead to reduced transmission of SARS-CoV-2.
Each of the two proposed agents to be tested have independently demonstrated virucidal activity with short contact time in vitro. With over 140 years of usage worldwide, the safety of gargles with Listerine Antiseptic® is well established. Topical nasal lavage using a dilute solution of baby shampoo has also been demonstrated to be safe and effective both as a mucoactive and microbicidal agent. Both agents are readily available and cost-efficient for daily usage.
While there are a number of ongoing trials of interventions with similar approaches, most of them focus on a single intervention, either nasal or oral rinses. This potentially leaves a viral reservoir in the untreated site, with the potential for recolonizing the entire oronasopharynx thereby limiting the utility of intervention. There is a single trial treating both the oral and nasal spaces. However, the agent being tested is povidone-iodine, that has known adverse effects limiting its use. These adverse effects include discoloration of teeth, ciliary dysfunction, iodine overdose and possible drug interactions, such as with lithium.
Investigators believe that the proposed intervention for this study is likely to be well-tolerated, highly acceptable and result in elimination from the key sites in the oronasopharynx. Additionally, the proposed four-arm design will allow investigators to compare the combined intervention with each of the component treatments. A decision was made to use saline rinses as the control arm as the investigator's in vitro data revealed that saline had no virucidal activity against human coronavirus.
Based on recent literature describing viral load dynamics during the course of SARS-CoV-2 infection, investigators believe that a four-day trial, initiated within 5 days of Covid testing, will allow for the testing of change in viral load close to/or within the 7-10 day timeframe of greatest SARS-CoV-2 viral load. The study period will also fall within the 2-3 week period of the mean duration of SARS-CoV-2. Mohamed et al suggest that 4 days of oral Listerine washes three times daily may be efficacious in decreasing viral load. Several other rinse trials also employ this rinse frequency. The rinse times of 60 secs and 30 secs for nasal wash with 1% dilute baby shampoo and oral Listerine respectively, are based on the successful virus reduction demonstrated at these contact times in vitro.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Shampoo and saline, Saline and Listerine, Shampoo and Listerine, Saline and Saline
- Keywords
- Covid 19, SARS-CoV-2, Viral Load, Nasal Rinse, Oral Rinse
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shampoo and salineCombination product
Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution
Saline and ListerineCombination product
Nasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution
Shampoo and ListerineCombination product
Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution
Saline and SalineCombination product
Nasal washes with buffered saline solution and oropharyngeal gargles with saline solution
| Study group | Role | What they receive |
|---|---|---|
| Baby Shampoo Nasal Wash | Active comparator | Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution Receives: Combination Product: Shampoo and saline |
| Listerine Gargle | Active comparator | Nasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution Receives: 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 Receives: Combination Product: Shampoo and Listerine |
| Saline Wash and Gargles | Placebo comparator | Nasal washes with buffered saline solution and oropharyngeal gargles with saline solution Receives: Combination Product: Saline and Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (7)
4-day trend in viral load change
The 4-day trend in viral load change in the nose and mouth of adults with SARS-CoV-2 infection measured with qPCR each morning on Days 1, 2, 3 and 4, as well as the post-intervention level measured on Day 5.
Measured: 5 days
Levels of live virus (viral infectivity titer)
The change in measured levels of live virus (viral infectivity titer), detected from the nose and mouth after the first wash on the morning of Day 1 compared to live virus detected before the first wash on Day 1 (baseline) . Infectivity will be measured by the number of plaque forming units in Vero cells
Measured: 15 minutes
Levels of live virus (viral infectivity titer)
The change in measured levels of live virus (viral infectivity titer) detected from the nose and mouth 24 hours after the initiation of rinses on Day 1. Infectivity will be measured by the number of plaque forming units in Vero cells
Measured: 1 day
The tolerability of the intervention measured using the validated Sino-nasal outcome test (SNOT-22) scale.
The tolerability of the intervention measured using the validated Sino-nasal outcome test (SNOT-22) scale.
The minimum score is 0 and the maximum score is 110, where a higher score is less tolerable.
Measured: 5 days
Compliance as measured by percent of expected washes completed
Participant compliance to the intervention will be calculated by percent of expected washes completed.
Measured: 5 days
Compliance as measured by percentage of randomized participants that withdrew consent and elected not to continue in the study.
Compliance will be measured by determining the percentage of randomized participants that withdrew consent and elected not to continue in the study.
Measured: 5 days
Acceptability of the intervention as measured by 7 item questionnaire based an acceptability framework described by Sekhon (2017)
The acceptability of the intervention, using a structured 7 item questionnaire based on the acceptability framework described by Sekhon (2017). The minimum score is 7 and the maximum score is 35. With the higher score being more acceptible.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Oct 2021
- Primary completion30 May 2024
- Study completion30 May 2024
Why it stopped: technical difficulties in sample analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AXIOM Real Time Metrics, Analytica Ventures LLC
- Responsible party
- Principal investigator, Rena Kass, Milton S. Hershey Medical Center
- Investigators
- Rena Kass, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802408
- Sponsor's protocol ID
- STUDY00016947
- Acronym
- SNOW
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32726430Sungnak 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.
PubMed 32327758Shrestha 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.
PubMed 32594116Cevik 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.
PubMed 33521734Mohamed 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
"Tracking the Coronavirus at U.S. Colleges and Universities." New York Times. Last updated Dec. 11, 2020.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial
- ClinicalTrials.gov ID
- NCT04802408
- Acronym / sponsor ID
- SNOW / STUDY00016947
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- Covid 19, SARS-CoV-2, Viral Load, Nasal Rinse, Oral Rinse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: technical difficulties in sample analysis
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- AXIOM Real Time Metrics, Analytica Ventures LLC
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators have demonstrated the in vitro viridical efficacy of both Listerine Antiseptic® and 1% dilute baby shampoo solution, a commonly used nasal rinse, against a SARS-CoV-2 surrogate and Meister et al. have similar findings with SARS-CoV-2. With an urgent need to expand the armamentarium of widely available, low-cost interventions, that are safe for repeated human use and reduce viral transmission, investigators seek to determine the impact of a combined regimen of oral and nasal rinsing with these agents on naso-oropharyngeal viral loads in adults (aged 18-65 years) with SARS-CoV-2 infection.
Rationale for the intervention: a combination of nasal washes with 1% solution of baby shampoo and oral washes with Listerine Antiseptic® Available data indicate that SARS-CoV-2 is most likely to spread, like most other common respiratory viruses, primarily through respiratory droplet transmission. With the naso-oropharynx being both the primary site from which the virus is expelled by people with infection and the nasal and oral mucosal cells is one of the sites of initial infection and viral replication. Specifically the ACE2 receptor, that SARS-CoV-2 binds for cell entry, are highly concentrated in the goblet and ciliated cells of the nose and on the tongue. Thus a reduction of viral load through topical treatment of these sites could potentially lead to reduced transmission of SARS-CoV-2.
Each of the two proposed agents to be tested have independently demonstrated virucidal activity with short contact time in vitro. With over 140 years of usage worldwide, the safety of gargles with Listerine Antiseptic® is well established. Topical nasal lavage using a dilute solution of baby shampoo has also been demonstrated to be safe and effective both as a mucoactive and microbicidal agent. Both agents are readily available and cost-efficient for daily usage.
While there are a number of ongoing trials of interventions with similar approaches, most of them focus on a single intervention, either nasal or oral rinses. This potentially leaves a viral reservoir in the untreated site, with the potential for recolonizing the entire oronasopharynx thereby limiting the utility of intervention. There is a single trial treating both the oral and nasal spaces. However, the agent being tested is povidone-iodine, that has known adverse effects limiting its use. These adverse effects include discoloration of teeth, ciliary dysfunction, iodine overdose and possible drug interactions, such as with lithium.
Investigators believe that the proposed intervention for this study is likely to be well-tolerated, highly acceptable and result in elimination from the key sites in the oronasopharynx. Additionally, the proposed four-arm design will allow investigators to compare the combined intervention with each of the component treatments. A decision was made to use saline rinses as the control arm as the investigator's in vitro data revealed that saline had no virucidal activity against human coronavirus.
Based on recent literature describing viral load dynamics during the course of SARS-CoV-2 infection, investigators believe that a four-day trial, initiated within 5 days of Covid testing, will allow for the testing of change in viral load close to/or within the 7-10 day timeframe of greatest SARS-CoV-2 viral load. The study period will also fall within the 2-3 week period of the mean duration of SARS-CoV-2. Mohamed et al suggest that 4 days of oral Listerine washes three times daily may be efficacious in decreasing viral load. Several other rinse trials also employ this rinse frequency. The rinse times of 60 secs and 30 secs for nasal wash with 1% dilute baby shampoo and oral Listerine respectively, are based on the successful virus reduction demonstrated at these contact times in vitro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Baby Shampoo Nasal Wash | Active comparator | Combination Product: Shampoo and salineNasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution |
| Listerine Gargle | Active comparator | Combination Product: Saline and ListerineNasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution |
| Combination of Baby Shampoo Nasal Wash and Listerine Gargle | Experimental | Combination Product: Shampoo and ListerineNasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution |
| Saline Wash and Gargles | Placebo comparator | Combination Product: Saline and SalineNasal washes with buffered saline solution and oropharyngeal gargles with saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shampoo and salineNasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution | Combination product | Baby Shampoo Nasal Wash |
| Saline and ListerineNasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution | Combination product | Listerine Gargle |
| Shampoo and ListerineNasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution | Combination product | Combination of Baby Shampoo Nasal Wash and Listerine Gargle |
| Saline and SalineNasal washes with buffered saline solution and oropharyngeal gargles with saline solution | Combination product | Saline Wash and Gargles |
Primary outcome
Viral Load Change from baseline
Time frame: 5 days
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.
7 secondary outcomes
4-day trend in viral load change
Time frame: 5 days
Levels of live virus (viral infectivity titer)
Time frame: 15 minutes
Levels of live virus (viral infectivity titer)
Time frame: 1 day
The tolerability of the intervention measured using the validated Sino-nasal outcome test (SNOT-22) scale.
Time frame: 5 days
Compliance as measured by percent of expected washes completed
Time frame: 5 days
Compliance as measured by percentage of randomized participants that withdrew consent and elected not to continue in the study.
Time frame: 5 days
Acceptability of the intervention as measured by 7 item questionnaire based an acceptability framework described by Sekhon (2017)
Time frame: 6 days
Results and safety
The study was stopped early (reason given: technical difficulties in sample analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 32726430Meister 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.
- Background: PubMed 32327758Sungnak 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.
- Background: PubMed 32594116Shrestha 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.
- Background: PubMed 33521734Cevik 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.
- BackgroundMohamed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena Kass, MD principal investigator
Penn State College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Saline and Listerine and Saline and Saline in people with Covid19 and SARS-CoV Infection, run by Milton S. Hershey Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: technical difficulties in sample analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load Change from baseline (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802408, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.