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Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04568876
Enrollment
40
Registered
2020-09-29
Start date
2020-10-23
Completion date
2021-02-28
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTMicronized 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

COMBINATION_PRODUCTStandard Therapy

Standard therapy established for individual patients

Sponsors

Azienda Ospedaliera Sant'Andrea
CollaboratorOTHER
Epitech Group SpA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of responder participants after 7 days of treatment7 daysResponder: decrease ≥ 30% from baseline of IL-6 blood levels

Secondary

MeasureTime frameDescription
Change of coagulation indices (INR, fibrinogen, D-dimer)0, 3, 7, 14, 28 days
Change of oxygenation indices (P/F ratio, lactates)0, 3, 7, 14, 28 days
Number of participants who developed delirium0, 3, 7, 14, 28 daysConfusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; \>1 delirium)
Number of participants who developed anxiety and/or depression0, 3, 7, 14, 28 daysHospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)
Change of pro-inflammatory markers (IL-6, IL-1 alpha, IL-1 beta, TNF-alpha, PCR, PCT, neopterin)0, 3, 7, 14, 28 days
Change of anti-inflammatory markers (IL-4, IL-10)0, 3, 7, 14, 28 days
Change of brain damage markers (S100b, ENS)0, 3, 7, 14, 28 days
Change of hematological parameters0, 3, 7, 14, 28 daysleukocyte formula (lymphocytes, CD4 / CD8 ratio)

Other

MeasureTime frame
Number of days of intensive care (ICU) hospitalization28 days
Number of days of non-invasive mechanical ventilation (Helmet, face mask)28 days
Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)28 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026