Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2021-02-28

Brief Summary

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SARS-CoV-2 infection is a condition characterized by excessive leukocyte infiltration, massive release of chemokines, proteases and cytokines, the so-called "cytokine storm", which promote the inflammatory process and contribute to exacerbation of COVID-19 symptomatology. Because of the abnormal release of pro-inflammatory cytokines by non-neuronal cells of the immune system, such as the mast cells in periphery, and microglia at central level, the body activates a defensive neuroinflammatory process that, if not controlled, can become pathological. Therefore it's important to intervene early on neuroinflammation, in order to limit the progression of the disease.

A possible intervention is represented by Palmitoylethanolamide (PEA), an endogenous molecule of the N-acylethanolamine family synthesized "on demand" in response to "stress factors" to restore tissue homeostasis, able to control mast cells and microglia uncontrolled activation. Experimental evidence in vitro and in vivo demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultra-micronized PEA (mPEA and umPEA), confirmed in various clinical investigations conducted in patients with different pathological conditions. The aim of this study is to investigate the efficacy of a compound containing mPEA + umPEA on peripheral inflammatory markers, neuroinflammation, and others clinical parameters in intensive care patients with COVID-19 interstitial pneumonia.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PEA Group

Normast® MPS (mPEA and umPEA 300mg + 600mg) oral suspension: 2700mg/die in 3 doses for 28 days, in add-on to standard therapy

Group Type ACTIVE_COMPARATOR

Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension

Intervention Type DIETARY_SUPPLEMENT

Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes

Standard Therapy

Intervention Type COMBINATION_PRODUCT

Standard therapy established for individual patients

Control Group

Standard therapy only

Group Type OTHER

Standard Therapy

Intervention Type COMBINATION_PRODUCT

Standard therapy established for individual patients

Interventions

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Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension

Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes

Intervention Type DIETARY_SUPPLEMENT

Standard Therapy

Standard therapy established for individual patients

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Normast® MPS oral suspension

Eligibility Criteria

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Inclusion Criteria

* Intensive Care Unit Hospitalization for interstitial pneumonia due to COVID-19 diagnosis (nasal swab/sputum/bronchoalveolar lavage positive for Sars-Cov-2 infection)

Exclusion Criteria

* Pregnancy or breastfeeding;
* Known allergy or hypersensitivity to the product or its excipients;
* Inability to take the product per os or via nasogastric tube.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No