TerminatedPhase 1/2

Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19

Stopped: Slow recruitment

United States20 participantsStarted 2021-09-30

Plain-language summary

This research study is a randomized controlled trial in pediatric and young adult patients who have lost their sense of smell due to COVID-19 viral infection. The goals are: 1. to learn more about the effects of smell retraining therapy on smell loss following COVID-19 and 2. to determine if budesonide-saline irrigations make smell retraining therapy more effective.

Who can participate

Age range

6 Years – 21 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: * Subjects ages 6 to 21 who have loss of smell (anosmia) or dysosmia (disordered smell perception) and thought to have occurred due to COVID-19. * Subjects who are able to complete the smell test (UPSIT), self-report their loss of smell, and do the assigned daily therapy. Exclusion Criteria: * Duration of anosmia or dysosmia \<60 days * Previous smell retraining * Prior interventions for loss of smell (excluding those on Flonase and Azelastine) * Contraindications for nasal budesonide treatment, as determined by the treating physician * Active cigarette smoker or use of vapes * Previous head trauma * Congenital anosmia * History of brain tumor * Neurocognitive disorders * Multiple sclerosis * Seizure disorder * Cystic fibrosis * Primary Ciliary Dyskinesia * History of nasal polyps * Inability to self-report

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

Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up

Timeframe: Before and after 8-12 weeks of smell retraining

Trial details

NCT IDNCT04964414

SponsorAmanda Stapleton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-13

Results submitted2024-01-10

View on ClinicalTrials.gov More Dysosmia trials