Clinical trial NCT04568876: Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Lead sponsor: Epitech Group SpA
Sponsor class: INDUSTRY
Collaborators: name: Azienda Ospedaliera "Sant'Andrea"
First posted: 2020-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of responder participants after 7 days of treatment
timeFrame: 7 days
Secondary outcomes:
measure: Change of pro-inflammatory markers (IL-6, IL-1 alpha, IL-1 beta, TNF-alpha, PCR, PCT, neopterin)
timeFrame: 0, 3, 7, 14, 28 days
measure: Change of anti-inflammatory markers (IL-4, IL-10)
timeFrame: 0, 3, 7, 14, 28 days
measure: Change of brain damage markers (S100b, ENS)
timeFrame: 0, 3, 7, 14, 28 days
measure: Change of coagulation indices (INR, fibrinogen, D-dimer)
timeFrame: 0, 3, 7, 14, 28 days
measure: Change of hematological parameters
timeFrame: 0, 3, 7, 14, 28 days
measure: Change of oxygenation indices (P/F ratio, lactates)
timeFrame: 0, 3, 7, 14, 28 days
measure: Number of participants who developed delirium
timeFrame: 0, 3, 7, 14, 28 days
measure: Number of participants who developed anxiety and/or depression
timeFrame: 0, 3, 7, 14, 28 days
Other outcomes:
measure: Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)
timeFrame: 28 days
measure: Number of days of non-invasive mechanical ventilation (Helmet, face mask)
timeFrame: 28 days
measure: Number of days of intensive care (ICU) hospitalization
timeFrame: 28 days
Locations:
city: Roma
country: Italy
facility: Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea
Study officials:
affiliation: Azienda Ospedaliera Universitaria Sant'Andrea di Roma
name: Prof.ssa Flaminia Coluzzi, MD
role: PRINCIPAL_INVESTIGATOR
References: