Status:
COMPLETED
COVID-19 Anosmia Study
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Anosmia
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To capture the natural history of COVID-19 associated olfactory dysfunction as measured by two patient reported outcome measures (SNOT-22, QOD-NS) and a 6-week BSIT with a comparison to an interventio...
Detailed Description
Infection with the novel coronavirus (COVID-19) has been linked to new-onset olfactory dysfunction, often as the only presenting symptom. In one multicenter European study, 85.6% of patients with mild...
Eligibility Criteria
Inclusion
- Adults (18 years of age or older) with self-reported new-onset olfactory dysfunction
- Positive COVID-19 diagnosis will be deemed eligible for inclusion.
Exclusion
- Patients \<18 years of age
- Patients who are unable to provide informed consent
- Patients without a positive COVID-19 PCR result obtained through nasopharyngeal swab - Patients with a COVID-19 diagnosis but without self-reported anosmia
- Patients with severe COVID-19 disease as defined by the Mouth Sinai Health System Treatment Guidelines for SARS-COV-2 (requiring high flow nasal cannula, non-rebreather, CPAP/BIPAP, or mechanical ventilation OR patients requiring pressor medication OR patients with evidence of end organ damage)
- Patients with pre-existing self-reported olfactory dysfunction
- Patients with a history of chronic nasal/sinus infections (rhinosinusitis) or history of endoscopic sinus surgery
- Patients using nasal steroid sprays or irrigations for any reason
- Patients who are prisoners of the state
- Patients who have psychiatric or developmental disorder conditions that may impair ability to provide informed consent
- Patients will also be excluded if they have an allergy to fish or an omega-3 supplement, or do not eat fish or fish- containing substances for any reason
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04495816
Start Date
July 15 2020
End Date
December 31 2021
Last Update
October 23 2023
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029