Coronavirus Smell Therapy for Anosmia Recovery (Co-STAR)
Anosmia
About this trial
This is an interventional treatment trial for Anosmia focused on measuring COVID, Smell Therapy
Eligibility Criteria
Inclusion Criteria:
- Adult women and men.
- Positive laboratory finding for SARS-CoV-2 (e.g., real-time reverse-transcription polymerase chain reaction (rRT-PCR) assays to detect viral RNA).
- In convalescence from their COVID-19 illness.
- Subjective complaints of reduced olfaction after COVID-19 infection of greater than 3 months duration.
- Reduced olfaction ability as determined by a score of <35 (women) or <34 (men) on the University of Pennsylvania Smell Identification Test (UPSIT ).
- Ability to read, write, and understand English.
Exclusion Criteria:
- History of olfaction disorder prior to COVID-19 infection.
- History of nasal cavity polyps.
- Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.
- History of cerebrospinal fluid leak.
- History of allergy to budesonide or other topical steroids.
- Pregnant or breast feeding or intend to become pregnant during the course of the trial.
- Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.
- Baseline UPSIT score 5 or below, which suggests malingering.
- History of neurodegenerative disease (i.e. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia).
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Budesonide & High-Concentration OLF
Placebo & High-Concentration OLF
Budesonide & Low-Concentration OLF
Placebo & Low-Concentration OLF
In this arm, subjects will perform nasal saline lavage (240 ml) with budesonide (0.5mg/capsule) and four different high-concentration (1 ml) essential oils for olfactory training twice daily.
In this arm, subjects will perform nasal saline lavage (240 ml) with placebo (lactose monohydrate) and four different high-concentration (1 ml) essential oils for olfactory training twice daily.
In this arm, subjects will perform nasal saline lavage (240 ml) with budesonide (0.5mg/capsule) and four different low-concentration (0.1 ml) essential oils for olfactory training twice daily.
In this arm, subjects will perform nasal saline lavage (240 ml) with placebo (lactose monohydrate) and four different low-concentration (0.1 ml) essential oils for olfactory training twice daily.