Sodium Citrate for Loss of Smell After COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a nasal spray with sodium citrate can improve the sense of smell in individuals who lost it after COVID-19. It compares the effects of sodium citrate spray with a normal saline spray (0.9% sodium chloride solution), alongside smell retraining exercises. Participants will use the spray and perform the exercises twice daily for 12 weeks. The trial seeks individuals who continue to experience difficulty smelling more than three months after a positive COVID-19 test. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using any investigational drugs or treatments for smell issues, you must stop those for at least three months before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sodium citrate can improve the sense of smell by influencing how signals reach the brain. It captures calcium, altering how smell signals are processed in the nose. This method may benefit those who lost their sense of smell after COVID-19.
The treatment is currently in a phase 2 trial, indicating some safety in earlier studies. Although detailed safety information for sodium citrate nasal spray specifically for smell loss is limited, its use in other areas suggests it is generally well-tolerated. So far, no major harmful side effects have been reported. However, as this is an experimental treatment, researchers will closely monitor participants for any negative effects during the trial.12345Why do researchers think this study treatment might be promising for loss of smell after COVID-19?
Unlike standard treatments for loss of smell after COVID-19, which often include olfactory training alone or corticosteroid sprays, sodium citrate offers a new approach by potentially altering the nasal environment to enhance smell recovery. Sodium citrate is administered as a nasal spray, which is a straightforward and non-invasive method, providing an alternative to more complex treatments. Researchers are excited about sodium citrate because it may work by modulating calcium ions in the nasal passages, thus directly targeting the underlying mechanisms of smell loss. This novel mechanism could offer a more effective and faster recovery pathway for patients struggling with post-COVID-19 olfactory issues.
What evidence suggests that sodium citrate might be an effective treatment for loss of smell after COVID-19?
Research has shown that sodium citrate nasal spray might help people regain their sense of smell after losing it due to reasons like long-term effects from COVID-19. In this trial, participants in the Sodium Citrate arm will use sodium citrate nasal spray and perform olfactory training twice a day for 12 weeks. One study found that people using sodium citrate experienced better improvements in their sense of smell compared to those who did not use it. This suggests that sodium citrate may help by boosting the smell signals in the nose, making it easier to notice scents. Although more research is needed, these early results offer hope for those who have lost their sense of smell after COVID-19.12467
Who Is on the Research Team?
Brent A. Senior, MD, FACS, FARS
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for individuals who have lost their sense of smell after having COVID-19 and are still experiencing this issue. Participants will use a nasal spray and undergo smell training twice daily for 12 weeks to see if it helps recover their sense of smell.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a nasal spray (either sodium citrate or normal saline) followed by olfactory retraining twice a day
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Normal Saline
- Olfactory Training Kit - "The Olfactory Kit, by AdvancedRx"
- Sodium Citrate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor