Phase 2 N=15 Randomized Quadruple-blind Treatment

Directed Topical Drug Delivery for Treatment for PASC Hyposmia

Post Acute Sequelae Covid-19 Hyposmia

Bottom Line

View on ClinicalTrials.gov: NCT05970731 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT) — 66.70; 28.57; 66.70; 42.86 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Beclomethasone (Drug); Placebo (Other); Microsponge (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT)	66.70; 28.57; 66.70; 42.86	—
SECONDARY Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD)	6.17; 2.66	—

Summary

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05970731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.