NCT04912921

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

Completed NA Last updated 8 March 2023

What this trial tests

NA trial testing palmitoylethanolamide in Inflammation in 115 participants. Completed in 15 May 2022.

Timeline

20 October 2020

Primary endpoint
15 May 2022

15 May 2022

Quick facts

Lead sponsor	Arizona State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	115
Start date	20 October 2020
Primary completion	15 May 2022
Estimated completion	15 May 2022
Sites	1 location across United States

Drugs / interventions tested

• palmitoylethanolamide — full drug profile →
• Placebo
• Curcumin (CURCUMIN) — full drug profile →
• Control (microcrystalline cellulose)

Conditions studied

• Inflammation — all drugs for Inflammation →
• COVID19 — all drugs for COVID19 →

Sponsor

Arizona State University

Who can join

Adults 18 to 65, any sex, with Inflammation or COVID19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stand Up to Stand Out: Natural Dietary Polyphenols Curcumin, Resveratrol, and Gossypol as Potential Therapeutic Candidates against Severe Acute Respiratory Syndrome Coronavirus 2 Infection.
   Wang Z, Song XQ, Xu W, Lei S, et al · · 2023 · cited 12× · PMID 37764669 · DOI 10.3390/nu15183885
2. Palmitoylethanolamide Reduces Proinflammatory Markers in Unvaccinated Adults Recently Diagnosed with COVID-19: A Randomized Controlled Trial.
   Fessler SN, Liu L, Chang Y, Yip T, et al · · 2022 · cited 9× · PMID 36084236 · DOI 10.1093/jn/nxac154
3. Curcumin Confers Anti-Inflammatory Effects in Adults Who Recovered from COVID-19 and Were Subsequently Vaccinated: A Randomized Controlled Trial.
   Fessler SN, Chang Y, Liu L, Johnston CS. · · 2023 · cited 7× · PMID 37049389 · DOI 10.3390/nu15071548
4. Curcumin as an antiviral agent and immune-inflammatory modulator in COVID-19: A scientometric analysis.
   Liu K, Zhu Y, Cao X, Liu Y, et al · · 2023 · cited 5× · PMID 38027776 · DOI 10.1016/j.heliyon.2023.e21648
5. Body Mass Index Is Associated with Post-Acute Elevations in Biomarkers of Platelet Activation and Inflammation in Unvaccinated Adults Diagnosed with COVID-19 in the Previous 8 Weeks.
   Fessler SN, Liu L, Chang Y, Johnston CS. · · 2024 · cited 1× · PMID 39116840 · DOI 10.1159/000540343