Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

Epitech Group

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Combination Product: Standard Therapy; Dietary Supplement: Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04568876

NORM_MPS_11 (Other Identifier)

NORM_MPS-COVID

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

PEA Group

Active Comparator group

Description:

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

Treatment:

Combination Product: Standard Therapy

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

Control Group

Other group

Description:

Standard therapy only

Treatment:

Combination Product: Standard Therapy