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

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: t
View:

• 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.

Locations
United States
New Jersey
Susan Dara
Edison
Time Frame
Start Date: 2022-01-10
Completion Date: 2023-04-21
Participants
Target number of participants: 32
Treatments
Experimental: 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.
Placebo_comparator: Control arm - placebo
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov