Directed Topical Drug Delivery for Treatment for PASC Hyposmia

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Post Acute Sequelae Covid-19 Hyposmia

🗓️ Study Start (Actual) 5 September 2023

🗓️ Primary Completion (Estimated) October 2024

✅ Study Completion (Estimated) October 2024

👥 Enrollment (Estimated) 20

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

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: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 24 July 2023
First Submitted that Met QC Criteria 24 July 2023
First Posted 1 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 24 June 2024
Last Update Posted 25 June 2024
Last Verified June 2024