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OpenTrials
Completed

NCT Number: NCT04912921

Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

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)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

About this study

Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and females 18-65 years old
  • Generally healthy
  • Able to provide informed consent
  • Recent positive COVID-19 test (per RT-PCR Test)*

Exclusion criteria

  • 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

Treatment and study plan

palmitoylethanolamide

Dietary Supplement

4 tablets taken daily (2 in the am and 2 in the pm)

Other names: Levagen

Placebo

Dietary Supplement

4 tablets taken daily (2 in am and 2 in pm)

Other names: microcrystalline cellulose

Curcumin

Dietary Supplement

500 mg HydroCurc® twice a day

Other names: Hydrocurc

Control (microcrystalline cellulose)

Dietary Supplement

2 tablets taken daily

Other names: microcrystalline cellulose

Primary outcomes

  1. IL6 concentration

    Time frame: change from baseline at day 28

    interleukin-6

Secondary outcomes

  1. serum CRP concentration

    Time frame: change from baseline at day 28

    C-reactive protein (high sensitivity)

  2. serum ferritin concentration

    Time frame: change from baseline at day 28

    serum ferritin

  3. serum ICAM concentration

    Time frame: change from baseline at day 28

    Intercellular Adhesion Molecule 1

  4. serum NFk-beta concentration

    Time frame: change from baseline at day 28

    nuclear factor kappa-light-chain-enhancer of activated B cells

  5. serum white blood cell differential

    Time frame: change from baseline at day 28

    white blood cell differential

  6. serum p-selectin concentration

    Time frame: change from baseline at day 28

    cell adhesion molecule

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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