NCT06204432Active, not recruitingPhase 2
Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction
Efficacy of Adjunctive Sodium Citrate in Smell Retraining for People With Post-Acute Sequelae COVID-19 Olfactory Dysfunction
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
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 dysfunction. The main questions it aims to answer are: * Is sodium citrate nasal spray in addition to smell retraining feasible for participants to use in terms of participant need/desire, adherence, and adverse events? * Does sodium citrate nasal spray in addition to smell retraining further improve smell as compared to normal saline spray and smell retraining? Participants will: * Provide consent for enrollment. * Undergo smell testing via Sniffin' Sticks. * Use a nasal spray (either sodium citrate or normal saline) followed by olfactory retraining twice a day for 12 weeks. * Return for follow-up Sniffin' Sticks testing. Researchers will compare the sodium citrate group and the normal saline group to determine differences in smell improvement.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06204432
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Dec 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with another investigational drug or other intervention for olfactory dysfunction within the prior three months.
- History of persistent olfactory dysfunction related to any other prior cause other than COVID-19 infection.
Other illness
- History of chronic sinusitis or nasal polyps.
- History of olfactory dysfunction following head trauma.
- History of sinus or skull base surgery.
Other
- Current smoker or inhaled tobacco use within the last three months.
- Congenital anosmia.
- Inability to return to UNC Health for follow-up.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.