CClinicalTrials.gg
CompletedNCT04347538Updated Oct 15, 2024Results posted

Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19

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

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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?

02

Conditions studied

  • COVID 19

Browse trials for

03

In context

COVID-19

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients testing positive for COVID-19 at Vanderbilt University Medical Center or VUMC-associated testing centers
  • Age of 18 years or greater
  • Patients must be planning self-quarantine after infection in the greater Nashville area within a 30-mile radius of Vanderbilt University Medical Center

Exclusion criteria

Exclusion Criteria:

  • Requiring hospitalization - only outpatient COVID-19 cases are eligible for the study
  • Current use of nasal saline irrigations or other intranasal medications
  • Inability to perform saline irrigations/nasal swabs in separate bathroom away from household contacts
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • No intervention
    Control Group, No intervention

    control group, no nasal irrigation

  • Experimental
    Saline Nasal Irrigation

    Nasal irrigation BID with normal saline

    Other: Saline Nasal Irrigation

  • Experimental
    Saline with Baby Shampoo Nasal Irrigation

    Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo

    Other: Saline with Baby Shampoo Nasal Irrigation

Interventions

  • OtherSaline Nasal Irrigation

    Saline nasal irrigation BID

  • OtherSaline with Baby Shampoo Nasal Irrigation

    Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Oct 15, 2024

Participant flow

Participant flow — Overall Study
MilestoneSaline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No Intervention
Started282931
Completed242424
Not completed457
Withdrew: Lost to follow-up457

Outcome measures

PrimaryChange 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
Reported as:
Median · Log10 copies/mL/days
Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection
Log10 copies/mL/daysSaline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl 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)
SecondarySymptom 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
Reported as:
Mean · score on a scale
Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-2
score on a scaleSaline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No Intervention
Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-213 ± 1416.3 ± 17.816.4 ± 11.8

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group, No Intervention0/31 (0%)0/31 (0%)0/31 (0%)
Saline Nasal Irrigation0/29 (0%)0/29 (0%)0/29 (0%)
Saline With Baby Shampoo Nasal Irrigation0/28 (0%)0/28 (0%)0/28 (0%)

Baseline characteristics

Baseline data is available only for those who completed the study.

Age, Categorical
Age, Categorical(Participants)Saline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No InterventionTotal
<=18 years0000
Between 18 and 65 years23242370
>=65 years1012
Age, Continuous
Age, Continuous(years)Saline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No InterventionTotal
Mean44 ± 1839 ± 1539 ± 1539 ± 23
Sex: Female, Male
Sex: Female, Male(Participants)Saline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No InterventionTotal
Female15121037
Male9121435
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Saline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No InterventionTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(Participants)Saline With Baby Shampoo Nasal IrrigationSaline Nasal IrrigationControl Group, No InterventionTotal
United States24242472
08

Study locations

1 site
  • Vanderblt University Medical Center
    Nashville, Tennessee 37232, United States
09

References and documents

Publications

  • Esther CR Jr, Kimura KS, Mikami Y, Edwards CE, Das SR, Freeman MH, Strickland BA, Brown HM, Wessinger BC, Gupta VC, Von Wahlde K, Sheng Q, Huang LC, Bacon DR, Kimple AJ, Ceppe AS, Kato T, Pickles RJ, Randell SH, Baric RS, Turner JH, Boucher RC. Pharmacokinetic-based failure of a detergent virucidal for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nasal infections: A preclinical study and randomized controlled trial. Int Forum Allergy Rhinol. 2022 Sep;12(9):1137-1147. doi: 10.1002/alr.22975. Epub 2022 Jan 31. PubMed 35040594 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 30, 2020
  • Informed consent form · Apr 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04347538
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Justin Turner (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Apr 15, 2020
Start date
May 1, 2020
Primary completion
Mar 16, 2022
Completion
Mar 16, 2022
Results posted
Oct 15, 2024
Last update
Oct 15, 2024

Study contacts

Kyle Kimura, MD
principal investigator · Vanderbilt University Medical Center
Justin H. Turner, MD, PhD
study director · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion