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OpenTrials
Completed

NCT Number: NCT04568876

Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea

Roma, 00189, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

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

Other names: Normast® MPS oral suspension

Standard therapy

Combination Product

Standard therapy established for individual patients

Primary outcomes

  1. Number of responder participants after 7 days of treatment

    Time frame: 7 days

    Responder: decrease ≥ 30% from baseline of IL-6 blood levels

Secondary outcomes

  1. Change of pro-inflammatory markers (IL-6, IL-1 alpha, IL-1 beta, TNF-alpha, PCR, PCT, neopterin)

    Time frame: 0, 3, 7, 14, 28 days

  2. Change of anti-inflammatory markers (IL-4, IL-10)

    Time frame: 0, 3, 7, 14, 28 days

  3. Change of brain damage markers (S100b, ENS)

    Time frame: 0, 3, 7, 14, 28 days

  4. Change of coagulation indices (INR, fibrinogen, D-dimer)

    Time frame: 0, 3, 7, 14, 28 days

  5. Change of hematological parameters

    Time frame: 0, 3, 7, 14, 28 days

    leukocyte formula (lymphocytes, CD4 / CD8 ratio)

  6. Change of oxygenation indices (P/F ratio, lactates)

    Time frame: 0, 3, 7, 14, 28 days

  7. Number of participants who developed delirium

    Time frame: 0, 3, 7, 14, 28 days

    Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; >1 delirium)

  8. Number of participants who developed anxiety and/or depression

    Time frame: 0, 3, 7, 14, 28 days

    Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)

Other outcomes

  1. Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)

    Time frame: 28 days

  2. Number of days of non-invasive mechanical ventilation (Helmet, face mask)

    Time frame: 28 days

  3. Number of days of intensive care (ICU) hospitalization

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Epitech Group SpA

Industry

Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

Registry information

Official study title

Efficacy of Palmitoylethanolamide, in add-on to Standard Therapy, on Inflammatory Markers of Patients With Interstitial Pneumonia Due to COVID-19. A Pilot Controlled, Randomized, Open Lable Clinical Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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