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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hackensack Meridian Health

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.