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NCT06204432 · ClinicalTrials.gov registry record · Phase 2
Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction
A Phase 2 study of Post-Acute COVID-19 Syndrome and Anosmia, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06204432: Active Phase 2 study of Post-Acute COVID-19 Syndrome and Anosmia, sponsored by University of North Carolina, Chapel Hill.
NCT06204432 is a Phase 2 study of Post-Acute COVID-19 Syndrome and Anosmia that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants, below the 840-participant average among 14 other Post-Acute COVID-19 Syndrome trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06204432, a Phase 2 study of Post-Acute COVID-19 Syndrome and Anosmia, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Number of Eligible Patients Who Meet the Inclusion Criteria
Conditions Studied
Interventions
- DRUG Normal Saline
- DRUG Sodium Citrate
- OTHER Olfactory Training Kit - "The Olfactory Kit, by AdvancedRx"
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT06204432 still lists
NCT06204432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 840-participant average among 14 other Post-Acute COVID-19 Syndrome trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Post-Acute COVID-19 Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Normal Saline is the first listed.
NCT06204432 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06204432 about?
NCT06204432 is a clinical study titled "Sodium Citrate in Smell Retraining for People With Post-COVID-19 Olfactory Dysfunction". 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 t...
What is the current status of trial NCT06204432?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-12-01. Estimated completion is 2025-12.
What conditions does trial NCT06204432 study?
This clinical trial studies the following conditions: Post-Acute COVID-19 Syndrome, Anosmia, Long Haul COVID-19, Olfaction Disorders.
What interventions are being tested in trial NCT06204432?
The interventions under investigation include: Normal Saline (DRUG), Sodium Citrate (DRUG), Olfactory Training Kit - "The Olfactory Kit, by AdvancedRx" (OTHER).
Who is sponsoring clinical trial NCT06204432?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06204432 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06204432's enrollment target sits among peer trials
60 7th of 14 higher than 7 of 14 other Post-Acute COVID-19 Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post-Acute COVID-19 Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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