Trial Outcomes & Findings for Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers (NCT NCT05121766)
NCT ID: NCT05121766
Last Updated: 2024-09-19
Results Overview
Number of participants who remain compliant for 12 weeks
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Study Arm - Omega 3 Supplement
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Study Arm - Omega 3 Supplement
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Overall Study
Covid reinfection
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers
Baseline characteristics by cohort
| Measure |
Study Arm - Omega 3 Supplement
n=16 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=16 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
46.44 years
n=5 Participants
|
47.25 years
n=7 Participants
|
46.84 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Number of participants who completed the 12-week intervention
Number of participants who remain compliant for 12 weeks
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=16 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=16 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Compliance as Captured by the Number of Participants Who Remain Compliant for the Whole Duration of the Study by Taking All Pills Daily
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 6 months recruitment efforts (starting on actual study start date)Population: Potential participants expressing interest in the study
Number of participants who expressed interest in learning about the study
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=93 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).
Interested to participate but not eligible
|
60 Participants
|
—
|
|
Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).
Chose not to participate after learning more about the study
|
1 Participants
|
—
|
|
Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).
Signed consent
|
32 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants that consented but did not completed 12 weeks of medication
Number of participants who initiate but do not complete study
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=16 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=16 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Retention as Illustrated by the Number of Participants That Initiate But do Not Complete the Study.
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: Number of participants experiencing shortness of breath at 12 weeks post treatment initiation
Self-reported shortness of breath as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=8 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=10 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: Number of participants experiencing cough at 12 weeks post treatment initiation
Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=7 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=10 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Impact of Omega-3 Supplement on Post-covid Symptoms - Cough
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: Number of participants experiencing fatigue at 12 weeks post treatment initiation
Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=7 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=10 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: Number of participants experiencing loss of smell at 12 weeks post treatment initiation
Self-reported loss of smell as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=7 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=10 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from baselinePopulation: Number of participants experiencing loss of taste at 12 weeks post treatment initiation
Self-reported loss of taste as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Outcome measures
| Measure |
Study Arm - Omega 3 Supplement
n=6 Participants
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=10 Participants
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste
|
4 Participants
|
2 Participants
|
Adverse Events
Study Arm - Omega 3 Supplement
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Arm - Placebo
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 |
Study Arm - Omega 3 Supplement
n=16 participants at risk
Omega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Omega-3 (EPA+DHA): Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).
Each capsule has 252mg of EPA and 102mg of DHA.
|
Control Arm - Placebo
n=16 participants at risk
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Placebo: 3 Soybean Oil Placebo capsules
|
|---|---|---|
|
General disorders
Excessive Fatigue
|
6.2%
1/16 • Number of events 1 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
|
Blood and lymphatic system disorders
Minimal bleeding
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
6.2%
1/16 • Number of events 2 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
|
Blood and lymphatic system disorders
Bloody nose
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
6.2%
1/16 • Number of events 4 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
|
Nervous system disorders
Localized pain
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
6.2%
1/16 • Number of events 1 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
12.5%
2/16 • Number of events 2 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
6.2%
1/16 • Number of events 1 • During the 12 weeks of the treatment with omega-3/placebo
Self-reporting adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place