Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study

Ultramicronized palmitoylethanolamide (um-PEA), a compound with antioxidant, anti-inflammatory and neuroprotective properties, appears to be a potential adjuvant treatment for early stages of Coronavirus disease 2019 (COVID-19). In our study, we enrolled 90 patients with confirmed diagnosis of COVID...

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Main Authors: Maria Albanese, Giulia Marrone, Agostino Paolino, Manuela Di Lauro, Francesca Di Daniele, Carlo Chiaramonte, Cartesio D’Agostini, Annalisa Romani, Alessandro Cavaliere, Cristina Guerriero, Andrea Magrini, Nicola Biagio Mercuri, Nicola Di Daniele, Annalisa Noce
Format: Article
Language:English
Published: MDPI AG 2022-02-01
Series:Pharmaceuticals
Subjects:
Online Access:https://www.mdpi.com/1424-8247/15/2/253
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author Maria Albanese
Giulia Marrone
Agostino Paolino
Manuela Di Lauro
Francesca Di Daniele
Carlo Chiaramonte
Cartesio D’Agostini
Annalisa Romani
Alessandro Cavaliere
Cristina Guerriero
Andrea Magrini
Nicola Biagio Mercuri
Nicola Di Daniele
Annalisa Noce
author_facet Maria Albanese
Giulia Marrone
Agostino Paolino
Manuela Di Lauro
Francesca Di Daniele
Carlo Chiaramonte
Cartesio D’Agostini
Annalisa Romani
Alessandro Cavaliere
Cristina Guerriero
Andrea Magrini
Nicola Biagio Mercuri
Nicola Di Daniele
Annalisa Noce
author_sort Maria Albanese
collection DOAJ
description Ultramicronized palmitoylethanolamide (um-PEA), a compound with antioxidant, anti-inflammatory and neuroprotective properties, appears to be a potential adjuvant treatment for early stages of Coronavirus disease 2019 (COVID-19). In our study, we enrolled 90 patients with confirmed diagnosis of COVID-19 that were randomized into two groups, homogeneous for age, gender and BMI. The first group received oral supplementation based on um-PEA at a dose of 1800 mg/day for a total of 28 days; the second group was the control group (R.S. 73.20). At baseline (T0) and after 28 days of um-PEA treatment (T1), we monitored: routine laboratory parameters, inflammatory and oxidative stress (OS) biomarkers, lymphocytes subpopulation and COVID-19 serological response. At T1, the um-PEA-treated group presented a significant reduction in inflammation compared to the control group (CRP <i>p</i> = 0.007; IL-6 <i>p</i> = 0.0001; neutrophils to lymphocytes ratio <i>p</i> = 0.044). At T1, the controls showed a significant increase in OS compared to the treated group (FORT <i>p</i> = 0.05). At T1, the um-PEA group exhibited a significant decrease in D-dimer levels (<i>p</i> = 0.0001) and higher levels of IgG against SARS-CoV-2 (<i>p</i> = 0.0001) compared to the controls. Our data demonstrated, in a randomized clinical trial, the beneficial effects of um-PEA in both asymptomatic and mild-symptomatic patients related to reductions in inflammatory state, OS and coagulative cascade alterations.
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spelling doaj.art-f809ad22d8134d10bc4f3c765562e4492023-11-23T21:35:29ZengMDPI AGPharmaceuticals1424-82472022-02-0115225310.3390/ph15020253Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control StudyMaria Albanese0Giulia Marrone1Agostino Paolino2Manuela Di Lauro3Francesca Di Daniele4Carlo Chiaramonte5Cartesio D’Agostini6Annalisa Romani7Alessandro Cavaliere8Cristina Guerriero9Andrea Magrini10Nicola Biagio Mercuri11Nicola Di Daniele12Annalisa Noce13Neurology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyUOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, ItalyUOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyPhD School of Applied Medical, Surgical Sciences, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of Statistics, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of Experimental Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyPHYTOLAB (Pharmaceutical, Cosmetic, Food Supplement, Technology and Analysis), DiSIA, University of Florence, Sesto Fiorentino, 50019 Florence, ItalyClinic Department of Gynecology Fabia Mater, 00171 Rome, ItalyUOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyDepartment of Biomedicine and Prevention, University of Rome Tor Vergata, 00133 Rome, ItalyNeurology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyUOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyUOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, ItalyUltramicronized palmitoylethanolamide (um-PEA), a compound with antioxidant, anti-inflammatory and neuroprotective properties, appears to be a potential adjuvant treatment for early stages of Coronavirus disease 2019 (COVID-19). In our study, we enrolled 90 patients with confirmed diagnosis of COVID-19 that were randomized into two groups, homogeneous for age, gender and BMI. The first group received oral supplementation based on um-PEA at a dose of 1800 mg/day for a total of 28 days; the second group was the control group (R.S. 73.20). At baseline (T0) and after 28 days of um-PEA treatment (T1), we monitored: routine laboratory parameters, inflammatory and oxidative stress (OS) biomarkers, lymphocytes subpopulation and COVID-19 serological response. At T1, the um-PEA-treated group presented a significant reduction in inflammation compared to the control group (CRP <i>p</i> = 0.007; IL-6 <i>p</i> = 0.0001; neutrophils to lymphocytes ratio <i>p</i> = 0.044). At T1, the controls showed a significant increase in OS compared to the treated group (FORT <i>p</i> = 0.05). At T1, the um-PEA group exhibited a significant decrease in D-dimer levels (<i>p</i> = 0.0001) and higher levels of IgG against SARS-CoV-2 (<i>p</i> = 0.0001) compared to the controls. Our data demonstrated, in a randomized clinical trial, the beneficial effects of um-PEA in both asymptomatic and mild-symptomatic patients related to reductions in inflammatory state, OS and coagulative cascade alterations.https://www.mdpi.com/1424-8247/15/2/253SARS-CoV-2COVID-19um-PEAoral food supplementcytokines stormoxidative stress
spellingShingle Maria Albanese
Giulia Marrone
Agostino Paolino
Manuela Di Lauro
Francesca Di Daniele
Carlo Chiaramonte
Cartesio D’Agostini
Annalisa Romani
Alessandro Cavaliere
Cristina Guerriero
Andrea Magrini
Nicola Biagio Mercuri
Nicola Di Daniele
Annalisa Noce
Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
Pharmaceuticals
SARS-CoV-2
COVID-19
um-PEA
oral food supplement
cytokines storm
oxidative stress
title Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
title_full Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
title_fullStr Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
title_full_unstemmed Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
title_short Effects of Ultramicronized Palmitoylethanolamide (um-PEA) in COVID-19 Early Stages: A Case–Control Study
title_sort effects of ultramicronized palmitoylethanolamide um pea in covid 19 early stages a case control study
topic SARS-CoV-2
COVID-19
um-PEA
oral food supplement
cytokines storm
oxidative stress
url https://www.mdpi.com/1424-8247/15/2/253
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