Status:
WITHDRAWN
Coronavirus Smell Therapy for Anosmia Recovery
Lead Sponsor:
Washington University School of Medicine
Conditions:
Anosmia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
As the COVID-19 pandemic spread around the world, anosmia and dysgeusia were quickly recognized as two of the key presenting symptoms. The probability of return of smell is related to severity of smel...
Detailed Description
This will be a virtual or "contactless" clinical trial. Subjects will be recruited through a variety of ways and will complete all baseline and post-intervention assessments via specially designed ele...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04422275
Start Date
June 1 2021
End Date
December 31 2023
Last Update
March 2 2021
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110