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

Study Overview
=================
Brief Summary
-----------------
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)

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) 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.

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

Conditions
-----------------
Inflammation, COVID19

Intervention / Treatment
-----------------
* Dietary Supplement: palmitoylethanolamide
* Dietary Supplement: Placebo
* Dietary Supplement: Curcumin
* Dietary Supplement: Control (microcrystalline cellulose)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind, randomized, controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palmitoylethanolamide<br>Levagen | Dietary Supplement: palmitoylethanolamide<br>* 4 tablets taken daily (2 in the am and 2 in the pm)<br>* Other names: Levagen;|
| Placebo Comparator: Placebo<br>microcrystalline cellulose | Dietary Supplement: Placebo<br>* 4 tablets taken daily (2 in am and 2 in pm)<br>* Other names: microcrystalline cellulose;|
| Experimental: HydroCurc<br>curcumin | Dietary Supplement: Curcumin<br>* 500 mg HydroCurc® twice a day<br>* Other names: Hydrocurc;|
| Placebo Comparator: Control<br>microcrystalline cellulose | Dietary Supplement: Control (microcrystalline cellulose)<br>* 2 tablets taken daily<br>* Other names: microcrystalline cellulose;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL6 concentration | interleukin-6 | change from baseline at day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum CRP concentration | C-reactive protein (high sensitivity) | change from baseline at day 28 | 
| serum ferritin concentration | serum ferritin | change from baseline at day 28 | 
| serum ICAM concentration | Intercellular Adhesion Molecule 1 | change from baseline at day 28 | 
| serum NFk-beta concentration | nuclear factor kappa-light-chain-enhancer of activated B cells | change from baseline at day 28 | 
| serum white blood cell differential | white blood cell differential | change from baseline at day 28 | 
| serum p-selectin concentration | cell adhesion molecule | change from baseline at day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palmitoylethanolamide, curcumin