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

NCT04347538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-10-15

Study results available
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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.

Conditions

  • COVID 19

Interventions

OTHER

Saline Nasal Irrigation

Saline nasal irrigation BID

OTHER

Saline with Baby Shampoo Nasal Irrigation

Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Kyle Kimura, MD · Vanderbilt University Medical Center

  • Justin H. Turner, MD, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-03-16
Completion
2022-03-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347538 on ClinicalTrials.gov