A Phase 4 interventional study of Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension and Standard Therapy in Covid19, sponsored by Epitech Group SpA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Epitech Group SpA · Phase 4, Interventional, and Supportive care
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
Normast® MPS (mPEA and umPEA 300mg + 600mg) oral suspension: 2700mg/die in 3 doses for 28 days, in add-on to standard therapy
Dietary Supplement: Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension · Combination Product: Standard Therapy
Standard therapy only
Combination Product: Standard Therapy
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Also known as: Normast® MPS oral suspension
Standard therapy established for individual patients
Number of responder participants after 7 days of treatment
Responder: decrease ≥ 30% from baseline of IL-6 blood levels
Time frame: 7 days
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
Change of anti-inflammatory markers (IL-4, IL-10)
Time frame: 0, 3, 7, 14, 28 days
Change of brain damage markers (S100b, ENS)
Time frame: 0, 3, 7, 14, 28 days
Change of coagulation indices (INR, fibrinogen, D-dimer)
Time frame: 0, 3, 7, 14, 28 days
Change of hematological parameters
leukocyte formula (lymphocytes, CD4 / CD8 ratio)
Time frame: 0, 3, 7, 14, 28 days
Change of oxygenation indices (P/F ratio, lactates)
Time frame: 0, 3, 7, 14, 28 days
Number of participants who developed delirium
Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; \>1 delirium)
Time frame: 0, 3, 7, 14, 28 days
Number of participants who developed anxiety and/or depression
Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)
Time frame: 0, 3, 7, 14, 28 days
Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)
Time frame: 28 days
Number of days of non-invasive mechanical ventilation (Helmet, face mask)
Time frame: 28 days
Number of days of intensive care (ICU) hospitalization
Time frame: 28 days
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Epitech Group SpA