Trial · NCT04495816
COVID-19 Anosmia Study
NCT04495816, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2023-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COVID-19 Anosmia Study. Trials, record NCT04495816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04495816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COVID-19 Anosmia Study
- NCT number
- NCT04495816
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Anosmia, Covid19
- Interventions
- Omega-3 Fatty Acid Supplement, Placebo/Control
- First posted
- 2020-08-03
- Last updated
- 2023-10-23
- Results first posted
- 2023-01-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Brief Smell Identification Test (BSIT) | 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. |
| Primary | Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction | 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. |
| Primary | Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction | 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. |
| Primary | Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 | Week 0 and Week 6 | Mean change in BSIT in participants with severe olfactory dysfunction defined as BSIT ≤ 6. Brief Smell Identification Test (BSIT) is a 12-item instrument, full range score from 0 to 12, higher score indicates better olfactory performances. |
| Secondary | Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) | 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). |
| Secondary | Sinonasal Outcomes Test (SNOT-22) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Brief Smell Identification Test (BSIT) | Week 0 and Week 6 | score on a scale | MEAN | |
| PRIMARY | Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction | Week 0 and Week 6 | Participants with severe olfactory dysfunction defined as BSIT ≤ 7 | score on a scale | MEAN |
| PRIMARY | Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction | Week 0 and Week 6 | Participants with Laboratory-Confirmed COVID-19 | score on a scale | MEAN |
| PRIMARY | Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 | Week 0 and Week 6 | Data not collected | ||
| SECONDARY | Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS) | baseline, weeks 1, 2, 4 and 6 after softgel initiation | score on a scale | MEAN | |
| SECONDARY | Sinonasal Outcomes Test (SNOT-22) | baseline, weeks 1, 2, 4 and 6 after softgel initiation | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Brief Smell Identification Test (BSIT) | Omega-3 | Baseline | 6.77 | Standard Deviation 1.94 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) | Placebo/Control | Baseline | 7.20 | Standard Deviation 1.88 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) | Omega-3 | Week 6 | 7.89 | Standard Deviation 2.00 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) | Placebo/Control | Week 6 | 7.88 | Standard Deviation 2.19 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) | Omega-3 | Change | 1.12 | Standard Deviation 1.99 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) | Placebo/Control | Change | 0.68 | Standard Deviation 1.86 | score on a scale |
| Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction | Omega-3 | 2.30 | Standard Deviation 1.77 | score on a scale | |
| Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction | Placebo/Control | 1.63 | Standard Deviation 1.82 | score on a scale | |
| Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction | Omega-3 | 1.18 | Standard Deviation 1.88 | score on a scale | |
| Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction | Placebo/Control | 0.61 | Standard Deviation 1.87 | score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omega-3 | 70 | |
| Overall Study | STARTED | Placebo/Control | 69 | |
| Overall Study | COMPLETED | Omega-3 | 57 | |
| Overall Study | COMPLETED | Placebo/Control | 60 | |
| Overall Study | NOT COMPLETED | Omega-3 | 13 | |
| Overall Study | NOT COMPLETED | Placebo/Control | 9 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | worsening of gastroesophageal reflux symptoms | Gastrointestinal disorders | Omega-3 | 0 | 70 | |
| other | worsening of gastroesophageal reflux symptoms | Gastrointestinal disorders | Placebo/Control | 3 | 69 | |
| other | unable to swallow the capsules | General disorders | Omega-3 | 0 | 70 | |
| other | unable to swallow the capsules | General disorders | Placebo/Control | 1 | 69 | |
| other | Unrelated upcoming surgery | General disorders | Omega-3 | 0 | 70 | |
| other | Unrelated upcoming surgery | General disorders | Placebo/Control | 1 | 69 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omega-3 | 0 | 70 |
| Total, all-cause mortality | Placebo/Control | 0 | 69 |
| Total, other adverse events | Omega-3 | 0 | 70 |
| Total, other adverse events | Placebo/Control | 5 | 69 |
| Total, serious adverse events | Omega-3 | 0 | 70 |
| Total, serious adverse events | Placebo/Control | 0 | 69 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omega-3 vs Placebo/Control: deaths from any cause | Trial comparisons |
| Omega-3 vs Placebo/Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04495816
GET https://conductscience.org/api/trials/v1/NCT04495816/results?page=2