An interventional study of Saline Nasal Irrigation and Saline with Baby Shampoo Nasal Irrigation in COVID 19, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
Nasal saline irrigations are a safe and commonly used mechanism to treat a variety of sinonasal diseases including sinusitis, rhinitis, and upper respiratory tract infections. When used properly, these irrigations are a safe and easy intervention available over the counter without a prescription. Additionally, baby shampoo has been found to be a safe additive functioning as a surfactant when a small amount is added to the saline rinses which may help augment clearance of the sinonasal cavity.
While many systemic medications and treatments have been proposed for COVID-19, there has not yet been a study looking at targeted local intervention to the nasal cavity and nasopharynx where the viral load is the highest. Studies have shown that the use of simple over the counter nasal saline irrigations can decrease viral shedding in the setting of viral URIs, including the common coronavirus (not SARS-CoV-2). Further, as SARS-CoV-2 is an enveloped virus, mild-detergent application with nasal saline would neutralize the virus further. It is our hypothesis that nasal saline or nasal saline with baby shampoo irrigations may decrease viral shedding/viral load and viral transmission, secondary bacterial load, nasopharyngeal inflammation in patients infected with the novel SARS-CoV-2.
The novel coronavirus known as SARS-CoV-2 and the associated disease process COVID-19 (coronavirus disease 2019) was first seen in late 2019 in Wuhan, China. Over the following months, it quickly spread across the continent and, in short order, the globe, making an impact that hasn't been seen in generations. Although coronaviruses have been prevalent for millennia, this version is immunologically novel, and thus there is no natural immunity to the virus. This has been a major reason for its rapid spread across the world.
Previous members of the coronavirus family have typically caused upper respiratory symptoms such as the common cold, though there have also been more virulent versions of this virus seen in the recent past, such as SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome). Similarly named, SARS-CoV-2 also causes upper respiratory symptoms but has varied from the previous viral syndromes in a number of ways including how quickly it has been able to transmit within a population. This is a disease that does not segregate and can affect all ages, genders, and ethnicities. Everyone is susceptible to this virus.
New diagnostic and therapeutic approaches for respiratory viruses are also being rapidly developed and polymerase chain reaction-based (PCR) diagnostics and multiplex assays are increasingly used in clinical laboratories for SARS-CoV-2 clinical detection and subtyping. Rapid antigenic and genetic evolution has been expected for SARS-CoV-2 strains, and a better understanding of SARS-CoV-2 evolutionary dynamics is needed to establish an effective vaccine.
Our present understanding of the nature and extent of the upper respiratory track (URT) microbiome in humans is limited. Furthermore, we have little understanding of how acute viral respiratory infections of SARS-CoV-2 influence the URT microbiome, or how genotypic differences in the virus influence the URT microbiome and vice versa. Innate immune responses to pathogens, along with dysregulation of inflammation, are key factors involved in pathogenesis, and different viral pathogens activate different types of inflammatory responses. Respiratory viral infection i.e., SARS-CoV-2 infection is expected to activate TLR2, TLR3, TLR4 and TLR7 responses and this is likely to modulate commensal microbiota populations. It is not yet known if the severity of SARS-CoV-2 disease in older adults is due to a biased host response, SARS-CoV-2 virulence determinants, or the impact infection has on commensal microbiota.
Up to this point, there is no unanimously approved treatment for the disease nor is there a vaccine or antiviral drugs available for the public. The primary methods for treatment of this deadly virus have been supportive in nature including intubation in severe cases with respiratory failure.
While a unanimous treatment has yet to be discovered, there has been a great amount of knowledge garnered over the last few months about the virus and the disease that accompanies it. Several studies have demonstrated high viral titers within the nasopharynx and oral cavity and many have posited that this is the primary source of infection and viral replication. Additionally, a high nasal/nasopharyngeal viral load has been associated with increased symptoms and higher severity of the disease.
Interestingly, there have been a number of studies recently looking at the effect of nasal saline irrigations in the setting of viral URIs, including coronaviruses (not including SARS-CoV-2). One of the major takeaways from these studies was decreased viral shedding in patients treated with saline irrigations compared to the control group. Nasal saline irrigations are available over the counter and widely viewed as both safe and affordable. Could these irrigations have a similar effect on the novel SARS-CoV-2 that they have on other viral respiratory infections?
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 88 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
control group, no nasal irrigation
Nasal irrigation BID with normal saline
Other: Saline Nasal Irrigation
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo
Other: Saline with Baby Shampoo Nasal Irrigation
Saline nasal irrigation BID
Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection
Perform qPCR Analysis to asses viral shedding over 21 day study period. Data expressed as viral shedding of N1 protein. Viral shedding = log10(change values at first day to the max value of Ct)/days between two values.
Time frame: Day 1 to day 21
Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-2
Identify symptom burden at day 5 using the modified Wisconsin Upper Respiratory System Survey 21. Minimum = 0. Maximum =21. Higher scores represent a worse outcomes.
Time frame: 21 days
| Milestone | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention |
|---|---|---|---|
| Started | 28 | 29 | 31 |
| Completed | 24 | 24 | 24 |
| Not completed | 4 | 5 | 7 |
| Withdrew: Lost to follow-up | 4 | 5 | 7 |
Perform qPCR Analysis to asses viral shedding over 21 day study period. Data expressed as viral shedding of N1 protein. Viral shedding = log10(change values at first day to the max value of Ct)/days between two values.
| Log10 copies/mL/days | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention |
|---|---|---|---|
| Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection | .116 (-.031 to 0.333) | .071 (-.047 to .253) | .118 (-.083 to .330) |
Identify symptom burden at day 5 using the modified Wisconsin Upper Respiratory System Survey 21. Minimum = 0. Maximum =21. Higher scores represent a worse outcomes.
| score on a scale | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention |
|---|---|---|---|
| Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-2 | 13 ± 14 | 16.3 ± 17.8 | 16.4 ± 11.8 |
Collected over Adverse events collected from time of consent through study completion, approximately 21 days after enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group, No Intervention | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Saline Nasal Irrigation | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Saline With Baby Shampoo Nasal Irrigation | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
Baseline data is available only for those who completed the study.
| Age, Categorical(Participants) | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 24 | 23 | 70 |
| >=65 years | 1 | 0 | 1 | 2 |
| Age, Continuous(years) | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention | Total |
|---|---|---|---|---|
| Mean | 44 ± 18 | 39 ± 15 | 39 ± 15 | 39 ± 23 |
| Sex: Female, Male(Participants) | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention | Total |
|---|---|---|---|---|
| Female | 15 | 12 | 10 | 37 |
| Male | 9 | 12 | 14 | 35 |
| Race and Ethnicity Not Collected(Participants) | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Saline With Baby Shampoo Nasal Irrigation | Saline Nasal Irrigation | Control Group, No Intervention | Total |
|---|---|---|---|---|
| United States | 24 | 24 | 24 | 72 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center