Post Acute Sequelae Covid-19 Hyposmia
Conditions
Keywords
Covid-19, smell loss, hyposmia
Brief 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.
Detailed description
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 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
Interventions
DRUGBeclomethasone
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.
OTHERPlacebo
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.
DEVICEMicrosponge
Drug delivery using chitosan-based biocompatible microsponge
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving MCID (Minimal Clinically Important Difference) on the Smell Identification Test (SIT) | Baseline, 1 month, 3 months | The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function. MCID is defined at a 4 point increase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Olfactory Quality of Life (QOL) Measured by the Questionnaire on Olfactory Disorders (QOD) | Baseline, 1 month, 3 months | 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. The change from baseline to 3 months is reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBradley Goldstein, MD, PhD
Duke Health
Participant flow
Recruitment details
Participants were recruited from an academic center otolaryngology clinic.
Pre-assignment details
One participant was found to be ineligible prior to arm assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 17.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
None listed