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Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction

NCT06204432 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Long Haul COVID-19
  • Post-Acute COVID-19 Syndrome
  • Anosmia
  • Olfaction Disorders

Interventions

DRUG

Sodium Citrate

Those randomized to the Sodium Citrate arm will use 1 mL of 2.5% sodium citrate (3.5g/140 mL, pH 7.4, 298 mOsmol/L), 0.5 mL in each nostril, twice a day via an atomizer followed by olfactory training.

DRUG

Normal Saline

Those randomized to the Normal Saline arm will use 1 mL of normal saline, 0.5 mL in each nostril, twice a day via an atomizer followed by olfactory training.

OTHER

Olfactory Training Kit - "The Olfactory Kit, by AdvancedRx"

All participants, regardless of study arm they are randomized to, will participate in olfactory training twice a day after use of their nasal spray

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Brent A. Senior, MD, FACS, FARS · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204432 on ClinicalTrials.gov