Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Study Overview
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Brief Summary
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This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.

Detailed Description
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Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2 follow-up visits at Week 6 and Week 12. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 12. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.

Official Title
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Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Conditions
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Post Acute Sequelae Covid-19 Hyposmia

Intervention / Treatment
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* Drug: Beclomethasone
* Other: Placebo
* Device: Microsponge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-COVID hyposmia lasting greater than 3 months following COVID19 by history Male or female, aged 18 years or older Exclusion Criteria: Pregnancy or lactation Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone Known diagnosis of glaucoma Febrile illness within 1 week Treatment with another investigational drug or other intervention within 3 months Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps Adults unable to consent Prisoners, employees or subordinates Individuals who are not yet adults (infants, children, teenagers)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beclomethasone<br>84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14) | Drug: Beclomethasone<br>* 84 mcg of Beclomethasone administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.<br>Device: Microsponge<br>* Drug delivery using chitosan-based biocompatible microsponge<br>|
| Placebo Comparator: Placebo<br>Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14) | Other: Placebo<br>* Placebo (0.9% sodium chloride) administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.<br>Device: Microsponge<br>* Drug delivery using chitosan-based biocompatible microsponge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in olfactory function as measured by the Smell Identification Test (SIT) | The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function. | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD) | The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL. | Baseline, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, smell loss, hyposmia