Trial Outcomes & Findings for COVID-19 Anosmia Study (NCT NCT04495816)
NCT ID: NCT04495816
Last Updated: 2023-10-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
139 participants
Primary outcome timeframe
Week 0 and Week 6
Results posted on
2023-10-23
Participant Flow
Participants with laboratory-confirmed or clinically-suspected COVID-19 infection and self-reported new-onset OD from August 2020 to November 2021 were prospectively recruited from otolaryngology and primary care practices across a large metropolitan health system as well as through a web-based symptom-tracking application and self-referral, resulting in a cohort of individuals from throughout the United States.
Participant milestones
| Measure |
Omega-3
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Omega-3
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omega-3
n=57 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=60 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 14.6 • n=57 Participants
|
40.7 years
STANDARD_DEVIATION 12.7 • n=60 Participants
|
41.1 years
STANDARD_DEVIATION 13.6 • n=117 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=57 Participants
|
46 Participants
n=60 Participants
|
92 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=57 Participants
|
14 Participants
n=60 Participants
|
25 Participants
n=117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Olfactory Dysfunction
Anosmia
|
45 Participants
n=57 Participants
|
47 Participants
n=60 Participants
|
92 Participants
n=117 Participants
|
|
Type of Olfactory Dysfunction
Hyposmia
|
4 Participants
n=57 Participants
|
6 Participants
n=60 Participants
|
10 Participants
n=117 Participants
|
|
Type of Olfactory Dysfunction
Parosmia
|
1 Participants
n=57 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=117 Participants
|
|
Type of Olfactory Dysfunction
Hyposmia & Parosmia
|
7 Participants
n=57 Participants
|
7 Participants
n=60 Participants
|
14 Participants
n=117 Participants
|
|
Anosmia Severity (Worst)
|
91.9 units on a scale
STANDARD_DEVIATION 16.9 • n=57 Participants
|
96.0 units on a scale
STANDARD_DEVIATION 8.54 • n=60 Participants
|
93.9 units on a scale
STANDARD_DEVIATION 13.3 • n=117 Participants
|
|
Anosmia Severity (Current)
|
68.1 units on a scale
STANDARD_DEVIATION 27.7 • n=57 Participants
|
73.2 units on a scale
STANDARD_DEVIATION 22.2 • n=60 Participants
|
70.8 units on a scale
STANDARD_DEVIATION 25.0 • n=117 Participants
|
|
Comorbidities, n (%)
Ageusia
|
41 Participants
n=57 Participants
|
48 Participants
n=60 Participants
|
89 Participants
n=117 Participants
|
|
Comorbidities, n (%)
History of Facial Trauma
|
2 Participants
n=57 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=117 Participants
|
|
Comorbidities, n (%)
Chronic Rhinosinusitis
|
1 Participants
n=57 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=117 Participants
|
|
Comorbidities, n (%)
Allergic Rhinitis
|
3 Participants
n=57 Participants
|
6 Participants
n=60 Participants
|
9 Participants
n=117 Participants
|
|
Comorbidities, n (%)
Neurodegenerative Disease
|
1 Participants
n=57 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=117 Participants
|
|
Duration of Olfactory Dysfunction Prior to Trial Start
|
196 days
STANDARD_DEVIATION 105 • n=57 Participants
|
204 days
STANDARD_DEVIATION 95.6 • n=60 Participants
|
200 days
STANDARD_DEVIATION 99.6 • n=117 Participants
|
|
Therapies Used Prior to Trial Start
Smell Training
|
24 Participants
n=57 Participants
|
24 Participants
n=60 Participants
|
48 Participants
n=117 Participants
|
|
Therapies Used Prior to Trial Start
Nasal Saline Spray or Irrigation
|
11 Participants
n=57 Participants
|
11 Participants
n=60 Participants
|
22 Participants
n=117 Participants
|
|
Therapies Used Prior to Trial Start
Intranasal Corticosteroid Spray or Irrigation
|
5 Participants
n=57 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=117 Participants
|
|
Therapies Used Prior to Trial Start
Oral Corticosteroids
|
0 Participants
n=57 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=117 Participants
|
|
Therapies Used Prior to Trial Start
Other
|
3 Participants
n=57 Participants
|
8 Participants
n=60 Participants
|
11 Participants
n=117 Participants
|
|
Concomitant Therapies Used During the Trial, n (%) ***
Smell Training
|
12 Participants
n=57 Participants
|
17 Participants
n=60 Participants
|
29 Participants
n=117 Participants
|
|
Concomitant Therapies Used During the Trial, n (%) ***
Nasal Saline
|
5 Participants
n=57 Participants
|
8 Participants
n=60 Participants
|
13 Participants
n=117 Participants
|
|
Concomitant Therapies Used During the Trial, n (%) ***
Intranasal Corticosteroid Spray or Irrigation
|
6 Participants
n=57 Participants
|
7 Participants
n=60 Participants
|
13 Participants
n=117 Participants
|
|
Concomitant Therapies Used During the Trial, n (%) ***
Oral Corticosteroids
|
5 Participants
n=57 Participants
|
3 Participants
n=60 Participants
|
8 Participants
n=117 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 6Change 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.
Outcome measures
| Measure |
Omega-3
n=57 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=60 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Change in Brief Smell Identification Test (BSIT)
Baseline
|
6.77 score on a scale
Standard Deviation 1.94
|
7.20 score on a scale
Standard Deviation 1.88
|
|
Change in Brief Smell Identification Test (BSIT)
Week 6
|
7.89 score on a scale
Standard Deviation 2.00
|
7.88 score on a scale
Standard Deviation 2.19
|
|
Change in Brief Smell Identification Test (BSIT)
Change
|
1.12 score on a scale
Standard Deviation 1.99
|
0.68 score on a scale
Standard Deviation 1.86
|
PRIMARY outcome
Timeframe: Week 0 and Week 6Population: Participants with severe olfactory dysfunction defined as BSIT ≤ 7
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.
Outcome measures
| Measure |
Omega-3
n=23 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=16 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction
|
2.30 score on a scale
Standard Deviation 1.77
|
1.63 score on a scale
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: Week 0 and Week 6Population: Participants with Laboratory-Confirmed COVID-19
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.
Outcome measures
| Measure |
Omega-3
n=51 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=51 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction
|
1.18 score on a scale
Standard Deviation 1.88
|
0.61 score on a scale
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: Week 0 and Week 6Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, weeks 1, 2, 4 and 6 after softgel initiationThe 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).
Outcome measures
| Measure |
Omega-3
n=57 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=60 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)
baseline
|
12.29 score on a scale
Standard Deviation 4.46
|
13.73 score on a scale
Standard Deviation 4.33
|
|
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)
week 2
|
11.46 score on a scale
Standard Deviation 4.81
|
12.76 score on a scale
Standard Deviation 4.41
|
|
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)
week 4
|
11.17 score on a scale
Standard Deviation 5.15
|
12.95 score on a scale
Standard Deviation 4.67
|
|
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)
week 6
|
11.19 score on a scale
Standard Deviation 4.58
|
12.33 score on a scale
Standard Deviation 4.80
|
|
Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)
week 1
|
11.41 score on a scale
Standard Deviation 4.42
|
12.54 score on a scale
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: baseline, weeks 1, 2, 4 and 6 after softgel initiationSino-Nasal Outcome Test (SNOT-22) is a 22-item instrument, total scale range from 0 to 110, higher score indicates more severe QOL impact.
Outcome measures
| Measure |
Omega-3
n=57 Participants
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=60 Participants
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Sinonasal Outcomes Test (SNOT-22)
baseline
|
22.35 score on a scale
Standard Deviation 13.23
|
25.75 score on a scale
Standard Deviation 12.43
|
|
Sinonasal Outcomes Test (SNOT-22)
week 1
|
21.23 score on a scale
Standard Deviation 13.60
|
24.54 score on a scale
Standard Deviation 12.90
|
|
Sinonasal Outcomes Test (SNOT-22)
week 2
|
21.41 score on a scale
Standard Deviation 14.33
|
22.90 score on a scale
Standard Deviation 12.58
|
|
Sinonasal Outcomes Test (SNOT-22)
week 4
|
20.79 score on a scale
Standard Deviation 13.56
|
23.47 score on a scale
Standard Deviation 13.82
|
|
Sinonasal Outcomes Test (SNOT-22)
week 6
|
19.91 score on a scale
Standard Deviation 13.05
|
22.41 score on a scale
Standard Deviation 13.58
|
Adverse Events
Omega-3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3
n=70 participants at risk
2,000mg daily of O3FA supplementation in the form of 2 capsules of Nature Made® Ultra Omega-3 Fish Oil 1400mg, each of which contains 1000 mg of O3FAs
|
Placebo/Control
n=69 participants at risk
received a placebo pill of identical size and shape to be taken twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
worsening of gastroesophageal reflux symptoms
|
0.00%
0/70 • 6 weeks
|
4.3%
3/69 • 6 weeks
|
|
General disorders
unable to swallow the capsules
|
0.00%
0/70 • 6 weeks
|
1.4%
1/69 • 6 weeks
|
|
General disorders
Unrelated upcoming surgery
|
0.00%
0/70 • 6 weeks
|
1.4%
1/69 • 6 weeks
|
Additional Information
Dr. David Lerner
Icahn School of Medicine at Mount Sinai
Phone: 212-241-9410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place