Sodium Citrate for Loss of Smell After COVID-19

Overseen By Lauren Cook

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Smoking, Chronic sinusitis, Head trauma, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

60 Participants Needed

Trial Summary

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 sodium citrate safe for treating loss of smell after COVID-19?

Saline irrigation, which is similar to sodium citrate, is considered safe and has low side effects when used for treating olfactory dysfunction (loss of smell) related to COVID-19. ^{1 2 3 4 5}

How does the treatment with the Olfactory Training Kit differ from other treatments for loss of smell after COVID-19?

The Olfactory Training Kit, which includes sodium citrate, is unique because it focuses on retraining the sense of smell through repeated exposure to specific scents, unlike other treatments that may use medications or supplements to address olfactory dysfunction. This approach is different from using drugs like nasal steroids or supplements like Palmitoylethanolamide and Luteolin, which aim to reduce inflammation or support nerve function. ^{1 3 4 6 7}

What is the purpose of this trial?

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.

Research Team

Brent A. Senior, MD, FACS, FARS

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

Provision of signed and dated informed consent form

Ability to use nasal spray and be willing to adhere to the nasal spray and olfactory training regimen

I have had a loss of smell since testing positive for COVID-19 over 3 months ago.

Exclusion Criteria

I have a history of chronic sinusitis or nasal polyps.

I have long-term smell loss not caused by COVID-19.

I have experienced a loss of smell due to a head injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use a nasal spray (either sodium citrate or normal saline) followed by olfactory retraining twice a day

12 weeks

3 virtual check-ins at days 7, 28, and 56

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) for Sniffin' Sticks assessment

Treatment Details

Interventions

• Normal Saline
• Olfactory Training Kit - "The Olfactory Kit, by AdvancedRx"
• Sodium Citrate

Trial Overview The study tests whether adding sodium citrate nasal spray to regular olfactory (smell) retraining can improve the sense of smell in people with long-term loss due to COVID-19, compared to using just normal saline spray with the same training.

Participant Groups

Group I: Sodium Citrate Experimental Treatment 2 Interventions

The Sodium Citrate arm will use sodium citrate nasal spray and olfactory training twice a day for 12 weeks.

Group II: Normal Saline Placebo Group 2 Interventions

The Normal Saline arm will use normal saline nasal spray and olfactory training twice a day for 12 weeks.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Findings from Research

Olfactory training (OT) is being investigated as a promising treatment for smell disorders in COVID-19 patients, which can significantly affect their quality of life.

This systematic review will assess the effectiveness and safety of OT, providing crucial evidence to support its use in treating smell dysfunction caused by COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smell disorders in COVID-19 patients: role of olfactory training: A protocol for systematic review and meta-analysis. Zhang, Y., Mei, T., Chen, Y., et al.[2023]

In a study of 150 COVID-19 patients with olfactory dysfunction, those treated with both saline irrigation and the nasal corticosteroid triamcinolone showed significantly improved olfactory function after 30 days compared to those receiving no treatment or only saline irrigation.

Topical triamcinolone was effective in reducing the duration of olfactory dysfunction, highlighting its potential as a safe and low-cost treatment option for patients experiencing smell loss due to COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Healing Effect of Nasal Saline Irrigation with Triamcinolone Acetonide Versus Nasal Saline Irrigation alone in COVID-19 Related Olfactory Dysfunction: A Randomized Controlled Study. Yildiz, E., Koca Yildiz, S., Kuzu, S., et al.[2022]

In a pilot study involving 27 patients with persistent olfactory dysfunction due to COVID-19, those treated with a combination of oral corticosteroids and olfactory training showed significant improvement in their sense of smell compared to those who only received olfactory training.

The treatment was found to be safe, with only minimal and transient side effects reported by a few participants, indicating that this approach could be a promising option for patients suffering from long-lasting olfactory loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral corticosteroids and olfactory training in the management of COVID-19-related loss of smell. Le Bon, SD., Konopnicki, D., Pisarski, N., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Palmitoylethanolamide and Luteolin Association on Post-Covid Olfactory Dysfunction: A Systematic Review and Meta-Analysis of Clinical Studies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Smell disorders in COVID-19 patients: role of olfactory training: A protocol for systematic review and meta-analysis. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Alpha-lipoic acid does not improve olfactory training results in olfactory loss due to COVID-19: a double-blind randomized trial. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Comparison of the Healing Effect of Nasal Saline Irrigation with Triamcinolone Acetonide Versus Nasal Saline Irrigation alone in COVID-19 Related Olfactory Dysfunction: A Randomized Controlled Study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral corticosteroids and olfactory training in the management of COVID-19-related loss of smell. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Saline Nasal Irrigation Plus Theophylline for Treatment of COVID-19-Related Olfactory Dysfunction: The SCENT2 Phase 2 Randomized Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A 32-Year-Old Man with Persistent Olfactory Dysfunction Following COVID-19 Whose Recovery Was Evaluated by Retronasal Olfactory Testing. [2022]