Clinical trial NCT05121766: Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: post-acute sequelae of covid-19
post- covid syndrome
long covid syndrome
healthcare workers
post-covid symptoms
quality of life
omega-3
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
measure: 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).
timeFrame: 6 months recruitment efforts (starting on actual study start date)
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath
timeFrame: 12 weeks from baseline
measure: Impact of Omega-3 Supplement on Post-covid Symptoms - Cough
timeFrame: 12 weeks from baseline
measure: Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue
timeFrame: 12 weeks from baseline
measure: Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell
timeFrame: 12 weeks from baseline
measure: Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Edison
country: United States
facility: Susan Dara
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Arunima Sarkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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