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

NCT ID: NCT04347538

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-03-16

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?

Conditions

COVID 19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group, No intervention

control group, no nasal irrigation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Saline Nasal Irrigation

Nasal irrigation BID with normal saline

Group Type: EXPERIMENTAL

Saline Nasal Irrigation

Intervention Type: OTHER

Saline nasal irrigation BID

Saline with Baby Shampoo Nasal Irrigation

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

Group Type: EXPERIMENTAL

Saline with Baby Shampoo Nasal Irrigation

Intervention Type: OTHER

Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

Interventions

Saline Nasal Irrigation

Saline nasal irrigation BID

Intervention Type: OTHER

Saline with Baby Shampoo Nasal Irrigation

Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Justin Turner

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Kimura, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Justin H. Turner, MD, PhD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderblt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35040594 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

200693

Identifier Type: -

Identifier Source: org_study_id