18 and older, any sex, with Anosmia or Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Brief Smell Identification Test (BSIT)Primary· Week 0 and Week 6
Change in BSIT. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.
Baseline
Group
Value
95% CI
Omega-3
6.77
± 1.94
Placebo/Control
7.20
± 1.88
Week 6
Group
Value
95% CI
Omega-3
7.89
± 2.00
Placebo/Control
7.88
± 2.19
Change
Group
Value
95% CI
Omega-3
1.12
± 1.99
Placebo/Control
0.68
± 1.86
Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory DysfunctionPrimary· Week 0 and Week 6
Mean change in BSIT in participants with severe olfactory dysfunction defined as BSIT ≤ 7. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.
Group
Value
95% CI
Omega-3
2.30
± 1.77
Placebo/Control
1.63
± 1.82
Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory DysfunctionPrimary· Week 0 and Week 6
Mean change in BSIT in participants with laboratory-confirmed COVID-19. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances.
Group
Value
95% CI
Omega-3
1.18
± 1.88
Placebo/Control
0.61
± 1.87
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)Secondary· baseline, weeks 1, 2, 4 and 6 after softgel initiation
The modified Brief Questionnaire of Olfactory Dysfunction - Negative Statements (QOD-NS) survey is a 17-item instrument, each item graded on a scale from 0 to 3, with total scale range from 0 to 51. Higher score indicates better olfactory-specific quality of life (QOL).
baseline
Group
Value
95% CI
Omega-3
12.29
± 4.46
Placebo/Control
13.73
± 4.33
week 1
Group
Value
95% CI
Omega-3
11.41
± 4.42
Placebo/Control
12.54
± 4.83
week 2
Group
Value
95% CI
Omega-3
11.46
± 4.81
Placebo/Control
12.76
± 4.41
week 4
Group
Value
95% CI
Omega-3
11.17
± 5.15
Placebo/Control
12.95
± 4.67
week 6
Group
Value
95% CI
Omega-3
11.19
± 4.58
Placebo/Control
12.33
± 4.80
Sinonasal Outcomes Test (SNOT-22)Secondary· baseline, weeks 1, 2, 4 and 6 after softgel initiation
Sino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.
baseline
Group
Value
95% CI
Omega-3
22.35
± 13.23
Placebo/Control
25.75
± 12.43
week 1
Group
Value
95% CI
Omega-3
21.23
± 13.60
Placebo/Control
24.54
± 12.90
week 2
Group
Value
95% CI
Omega-3
21.41
± 14.33
Placebo/Control
22.90
± 12.58
week 4
Group
Value
95% CI
Omega-3
20.79
± 13.56
Placebo/Control
23.47
± 13.82
week 6
Group
Value
95% CI
Omega-3
19.91
± 13.05
Placebo/Control
22.41
± 13.58
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06733636 — Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
· NA
· recruiting
NCT05562050 — Characteristics of the Anosmic Olfactory Mucosa
· active not recruiting
NCT05040659 — Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
· active not recruiting
NCT05364125 — Olfactory Training on Smell Dysfunction Patients in HK
· NA
· recruiting
NCT06423495 — Efficacy of Photobiomodulation in the Rehabilitation of Olfactory Dysfunctions Induced by Long COVID-19
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 23 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04495816.