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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04347538
Enrollment
88
Registered
2020-04-15
Start date
2020-05-01
Completion date
2022-03-16
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Brief 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.

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?

Interventions

Saline nasal irrigation BID

OTHERSaline with Baby Shampoo Nasal Irrigation

Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients enrolled will be randomized to one of three treatment groups (1. control- no intervention, 2. intervention 1 - nasal saline irrigations BID, 3. intervention 2- nasal saline irrigations with ½ teaspoon surfactant (Johnson's baby shampoo) BID).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Viral Load in the Nasopharynx Over the Course of COVID-19 InfectionDay 1 to day 21Perform 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.

Secondary

MeasureTime frameDescription
Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-221 daysIdentify symptom burden at day 5 using the modified Wisconsin Upper Respiratory System Survey 21. Minimum = 0. Maximum =21. Higher scores represent a worse outcomes.

Countries

United States

Participant flow

Participants by arm

ArmCount
Saline With Baby Shampoo Nasal Irrigation
Nasal irrigation BID with normal saline and 1/2 teaspoon baby shampoo Saline with Baby Shampoo Nasal Irrigation: Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.
24
Saline Nasal Irrigation
Nasal irrigation BID with normal saline Saline Nasal Irrigation: Saline nasal irrigation BID
24
Control Group, No Intervention
control group, no nasal irrigation
24
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up457

Baseline characteristics

CharacteristicSaline Nasal IrrigationControl Group, No InterventionSaline With Baby Shampoo Nasal IrrigationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
24 Participants23 Participants23 Participants70 Participants
Age, Continuous39 years
STANDARD_DEVIATION 15
39 years
STANDARD_DEVIATION 15
44 years
STANDARD_DEVIATION 18
39 years
STANDARD_DEVIATION 23
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
24 Participants24 Participants24 Participants72 Participants
Sex: Female, Male
Female
12 Participants10 Participants15 Participants37 Participants
Sex: Female, Male
Male
12 Participants14 Participants9 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 290 / 28
other
Total, other adverse events
0 / 310 / 290 / 28
serious
Total, serious adverse events
0 / 310 / 290 / 28

Outcome results

Primary

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

ArmMeasureValue (MEDIAN)
Saline With Baby Shampoo Nasal IrrigationChange in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection.116 Log10 copies/mL/days
Saline Nasal IrrigationChange in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection.071 Log10 copies/mL/days
Control Group, No InterventionChange in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection.118 Log10 copies/mL/days
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Saline With Baby Shampoo Nasal IrrigationSymptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-213 score on a scaleStandard Deviation 14
Saline Nasal IrrigationSymptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-216.3 score on a scaleStandard Deviation 17.8
Control Group, No InterventionSymptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-216.4 score on a scaleStandard Deviation 11.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026