Status:
ACTIVE_NOT_RECRUITING
Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Long Haul COVID-19
Post-Acute COVID-19 Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this pilot study is to assess the feasibility and impact of using sodium citrate nasal spray as an adjunct to olfactory retraining in participants with long-term post-COVID-19 olfactory dy...
Detailed Description
Background: Loss of sense of smell is a hallmark of COVID-19 infection. While about 80% of post-COVID olfactory dysfunction (OD) will experience some spontaneous recovery within 2 months of initial in...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male and female, ages greater than or equal to 18 years.
- Patients with persistent olfactory dysfunction originating at the time of a confirmed COVID-19 positive test occurring greater than 3 months ago.
- Ability to use nasal spray and be willing to adhere to the nasal spray and olfactory training regimen
Exclusion
- Treatment with another investigational drug or other intervention for olfactory dysfunction within the prior three months.
- Current smoker or inhaled tobacco use within the last three months.
- History of chronic sinusitis or nasal polyps.
- History of olfactory dysfunction following head trauma.
- History of sinus or skull base surgery.
- History of persistent olfactory dysfunction related to any other prior cause other than COVID-19 infection.
- Congenital anosmia.
- Inability to return to UNC Health for follow-up.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06204432
Start Date
December 1 2023
End Date
December 1 2025
Last Update
February 20 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599