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NCT04347538 · ClinicalTrials.gov registry record · NA
Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19
A NA study of COVID-19, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT04347538: Completed NA study of COVID-19, sponsored by Vanderbilt University Medical Center.
NCT04347538 is a NA study of COVID-19 that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 88 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04347538, a NA study of COVID-19, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Saline Nasal Irrigation
- OTHER Saline with Baby Shampoo Nasal Irrigation
Study Locations (1)
Tennessee
- Vanderblt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2022-03-16 |
| Phase | NA |
What the finished NCT04347538 record still lists
NCT04347538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Saline Nasal Irrigation is the first listed.
NCT04347538 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04347538 about?
NCT04347538 is a clinical study titled "Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19". 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. Ad...
What is the current status of trial NCT04347538?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2020-05-01. Estimated completion is 2022-03-16.
What conditions does trial NCT04347538 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04347538?
The interventions under investigation include: Saline Nasal Irrigation (OTHER), Saline with Baby Shampoo Nasal Irrigation (OTHER).
Who is sponsoring clinical trial NCT04347538?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04347538 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04347538's enrollment target sits among peer trials
88 211th of 298 higher than 88 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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