Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers

Study Overview
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Brief Summary
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This is a two-arm, double blind randomized 12-week study to supplement omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute sequelae of covid-19 (also called post-covid syndrome or long covid syndrome).

Detailed Description
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This is a double-blind, randomized controlled trial (RCT) with two treatment arms: Arm 1 - Omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - 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. Support for dosing: The American Heart Association (AHA) says taking up to 3 grams of fish oil daily in supplement form is considered safe; Up to 5,000mg of omega-3 fatty acids per day is considered safe; The U.S. Food and Drug Administration recommends consuming no more than 3 g/day of EPA and DHA combined, including up to 2 g/day from dietary supplements. Arm 2 - Placebo - made from soybean oil (same dosing schedule as intervention arm)

Official Title
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Feasibility Pilot Clinical Trial of Omega-3 (EPA+DHA) Supplement vs. Placebo for Post-Acute Sequelae of Coronavirus-19 (COVID-19) Recovery Among Health Care Workers

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Omega-3 (EPA+DHA)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Team member at Hackensack Meridian Health Age: 18+ Willing to provide informed consent Formal diagnosis of COVID-19 via Polymerase Chain Reaction (PCR)test (if home test was done, team member must confirm via PCR test) Outpatient treatment only for covid-19; no hospitalization (most team members will be vaccinated and may likely have milder case) Must be experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell) Symptom(s) have persisted for more than 12 weeks after initial infection Symptom(s) coincided with covid-19 infection and were not present prior to covid-19 infection Does not have soy allergy Does not have allergy to fish Able to participate in bi-weekly surveys in Research Electronic Data Capture (REDCap) Able to take own blood pressure and record it in bi-weekly REDCap survey Willing to participate in 12-week study and be assigned to either intervention or placebo arm Not currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry). Able to take/swallow six mini-pills daily Able and willing to give a spot blood sample (2 drops) at baseline and end of study. Exclusion Criteria: Not a Team Member at Hackensack Meridian Health Not age 18+ Unwilling to provide informed consent/ declined to take part No formal diagnosis of COVID-19 via PCR test (if home test was done, team member must confirm via PCR test) Were hospitalized for treatment of covid-19 Not experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell) Symptom(s) have persisted for more than 12 weeks after initial infection Symptom(s) did not coincide with covid-19 infection and were present prior to covid-19 infection Does have soy allergy Does have allergy to fish Not able to participate in bi-weekly surveys in REDCap Able to take own blood pressure and record it in bi-weekly REDCap survey Not willing to participate in 12-week study and be assigned to either intervention or placebo arm Currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry). Unable to take/swallow six mini-pills daily Not able and not willing to give a spot blood sample (2 drops) at baseline and end of study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm - Omega 3 supplement<br>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. | Drug: Omega-3 (EPA+DHA)<br>* 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.<br>* Other names: fish oil;|
| Placebo Comparator: Control arm - placebo<br>3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day). | Drug: Placebo<br>* 3 Soybean Oil Placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of participants who remain compliant for 12 weeks | 12 weeks | 
| 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). | Number of participants approached but not interested in participating | 6 months recruitment efforts (starting on actual study start date) | 
| 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. | Number of participants who initiate but do not complete study | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of omega-3 supplement on post-covid symptoms - Shortness of breath | 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). | 12 weeks from baseline | 
| Impact of omega-3 supplement on post-covid symptoms - Cough | Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post). | 12 weeks from baseline | 
| Impact of omega-3 supplement on post-covid symptoms - Fatigue | Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post). | 12 weeks from baseline | 
| Impact of omega-3 supplement on post-covid symptoms - Loss of smell | 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). | 12 weeks from baseline | 
| Impact of omega-3 supplement on post-covid symptoms - Loss of taste | 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). | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-acute sequelae of covid-19, post- covid syndrome, long covid syndrome, healthcare workers, post-covid symptoms, quality of life, omega-3