Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction (NCT06204432) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction
United States60 participantsStarted 2023-12-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Eligible Patients
Timeframe: 1 year
2
The Proportion of Participants Who Were Enrolled in the Study
Timeframe: 1 year
3
The Proportion of Participants Who Complete the Study
Timeframe: 1 year
4
Proportion of Participants Who Report Minor or Severe Adverse Events