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

NCT04347538 | Completed Results

• 1 other identifier: 200693
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Outcome Measures

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.

  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

  21 days

Study Arms (3)

Control Group, No intervention

NO INTERVENTION

control group, no nasal irrigation

Saline Nasal Irrigation

EXPERIMENTAL

Nasal irrigation BID with normal saline

Other: Saline Nasal Irrigation

Saline with Baby Shampoo Nasal Irrigation

EXPERIMENTAL

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

Other: Saline with Baby Shampoo Nasal Irrigation

Interventions

Saline Nasal Irrigation OTHER

Saline nasal irrigation BID

Saline Nasal Irrigation

Saline with Baby Shampoo Nasal Irrigation OTHER

Saline with 1/2 teaspoon Baby Shampoo Nasal Irrigation.

Saline with Baby Shampoo Nasal Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderblt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 35040594 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Justin H. Turner, MD, PhD
• Organization: Vanderbilt University Medical Center

justin.h.turner@vumc.org

615-343-8848

Study Officials

• Kyle Kimura, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Justin H. Turner, MD, PhD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: May 1, 2020
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)