Phase 2
N=139
COVID-19 Anosmia Study
Anosmia · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04495816 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Change in Brief Smell Identification Test (BSIT) — 6.77; 7.20; 7.89; 7.88 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omega-3 Fatty Acid Supplement (Drug); Placebo/Control (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brief Smell Identification Test (BSIT) |
6.77; 7.20; 7.89; 7.88; 1.12; 0.68 | — |
| PRIMARY Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction |
2.30; 1.63 | — |
| PRIMARY Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction |
1.18; 0.61 | — |
| PRIMARY Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 |
— | — |
| SECONDARY Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) |
12.29; 13.73; 11.41; 12.54; 11.46; 12.76 | — |
| SECONDARY Sinonasal Outcomes Test (SNOT-22) |
22.35; 25.75; 21.23; 24.54; 21.41; 22.90 | — |
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 intervention arm receiving daily omega-3 supplements.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04495816). 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.