Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
Completed · Not applicable · Has a placebo group
Conditions studied: Inflammation, COVID19
In brief
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)
Key facts
- Study ID
- NCT04912921
- Run by
- Arizona State University
- People needed
- 115
- Starts
- 2020-10-20
- Expected to finish
- 2022-05-15
- Last updated by the study team
- 2023-03-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and females 18-65 years old
- Generally healthy
- Able to provide informed consent
- Recent positive COVID-19 test (per RT-PCR Test)*
You may not qualify if…
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
- Serious mood disorders, neurological disorders such as MS, or cognitive damage
- Active smokers and/or nicotine or drug abuse
- Active, regular marijuana or other cannabinoid use, other street/recreational drug use
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric
- Pregnant or lactating woman
- People medically prescribed to take drugs that would affect the immune and/or the inflammatory response
- People who have had treatment (last 5 years) for cancer, or chronic use of steroids
- BMI >40
Where it is running
- Arizona Biomedical Collaborative — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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