COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05121766

Sarkar, A

None

2021-11-16

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Long covid

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.

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.

2

Hackensack Meridian Health

18

89

United States

Patients recovered from covid

N/A

32

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;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).;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.

None

Phase 1

[{"arm_notes": "Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). ", "treatment_id": 926, "treatment_name": "Omega dha/epa", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]