N/A N=88 Randomized Treatment

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

COVID 19

Bottom Line

View on ClinicalTrials.gov: NCT04347538 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection — .116; .071; .118 Log10 copies/mL/days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Saline Nasal Irrigation (Other); Saline with Baby Shampoo Nasal Irrigation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Viral Load in the Nasopharynx Over the Course of COVID-19 Infection	.116; .071; .118	—
SECONDARY Symptom Assessment Via Wisconsin Upper Respiratory System Survey 21 With Additional Symptoms Prevalent During SARS-CoV-2	13; 16.3; 16.4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04347538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.