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

• Sponsor: Arizona State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04912921
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.8
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

This is a randomized controlled trial 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).

Condition or Disease	Intervention/Treatment	Phase
Inflammation; COVID19	Dietary Supplement: palmitoylethanolamide; Dietary Supplement: Placebo	N/A

Detailed Description

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) 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 this dietary supplement 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blind, randomized, controlled trialdouble-blind, randomized, controlled trial
• Masking: Double (Participant, Investigator)
• Masking Description: Palmitoylethanolamide and placebo tablets are identical in appearance and presented to participant in unlabeled opaque containers by investigators blinded to container content.
• Primary Purpose: Supportive Care
• Official Title: Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
• Actual Study Start Date: Oct 20, 2020
• Actual Primary Completion Date: May 15, 2022
• Actual Study Completion Date: May 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: palmitoylethanolamide Levagen	Dietary Supplement: palmitoylethanolamide; 4 tablets taken daily (2 in the am and 2 in the pm); Other Names: Levagen
Placebo Comparator: Placebo microcrystalline cellulose	Dietary Supplement: Placebo; 4 tablets taken daily (2 in am and 2 in pm); Other Names: microcrystalline cellulose

Outcome Measures

Primary Outcome Measures

1. IL6 concentration [change from baseline at day 28]

   interleukin-6

Secondary Outcome Measures

1. serum CRP concentration [change from baseline at day 28]

   C-reactive protein (high sensitivity)

2. serum ferritin concentration [change from baseline at day 28]

   serum ferritin

3. serum ICAM concentration [change from baseline at day 28]

   Intercellular Adhesion Molecule 1

4. serum NFk-beta concentration [change from baseline at day 28]

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

5. serum white blood cell differential [change from baseline at day 28]

   white blood cell differential

6. serum p-selectin concentration [change from baseline at day 28]

   cell adhesion molecule

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Biomedical Collaborative	Phoenix	Arizona	United States	85004

Sponsors and Collaborators

• Arizona State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arizona State University
• ClinicalTrials.gov Identifier: NCT04912921
• Other Study ID Numbers: STUDY00012462
• First Posted: Jun 3, 2021
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arizona State University: palmitoylethanolamide
• Additional relevant MeSH terms: COVID-19; Inflammation; Palmidrol

Study Results

No Results Posted as of Aug 16, 2022