Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568876
• Other study ID #: NORM_MPS-COVID
• Secondary ID: NORM_MPS_11
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2021
• Source: Epitech Group SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Dietary Supplement:
• Micronized 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 Product:
• Standard Therapy
Standard therapy established for individual patients

Locations

Country	Name	City	State
Italy	Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Epitech Group SpA	Azienda Ospedaliera "Sant'Andrea"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)		28 days
Other	Number of days of non-invasive mechanical ventilation (Helmet, face mask)		28 days
Other	Number of days of intensive care (ICU) hospitalization		28 days
Primary	Number of responder participants after 7 days of treatment	Responder: decrease = 30% from baseline of IL-6 blood levels	7 days
Secondary	Change of pro-inflammatory markers (IL-6, IL-1 alpha, IL-1 beta, TNF-alpha, PCR, PCT, neopterin)		0, 3, 7, 14, 28 days
Secondary	Change of anti-inflammatory markers (IL-4, IL-10)		0, 3, 7, 14, 28 days
Secondary	Change of brain damage markers (S100b, ENS)		0, 3, 7, 14, 28 days
Secondary	Change of coagulation indices (INR, fibrinogen, D-dimer)		0, 3, 7, 14, 28 days
Secondary	Change of hematological parameters	leukocyte formula (lymphocytes, CD4 / CD8 ratio)	0, 3, 7, 14, 28 days
Secondary	Change of oxygenation indices (P/F ratio, lactates)		0, 3, 7, 14, 28 days
Secondary	Number of participants who developed delirium	Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; >1 delirium)	0, 3, 7, 14, 28 days
Secondary	Number of participants who developed anxiety and/or depression	Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)	0, 3, 7, 14, 28 days