Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

Phase 4

Completed

• Conditions: Covid19

• Registration Number: NCT04568876
• Lead Sponsor: Epitech Group SpA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-29
• Study Start: 2020-10-23
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of responder participants after 7 days of treatment	7 days	Responder: decrease ≥ 30% from baseline of IL-6 blood levels

Secondary Outcome Measures

Name	Time	Method
Number of participants who developed delirium	0, 3, 7, 14, 28 days	Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; \>1 delirium)
Change of coagulation indices (INR, fibrinogen, D-dimer)	0, 3, 7, 14, 28 days
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 brain damage markers (S100b, ENS)	0, 3, 7, 14, 28 days
Change of hematological parameters	0, 3, 7, 14, 28 days	leukocyte formula (lymphocytes, CD4 / CD8 ratio)
Change of anti-inflammatory markers (IL-4, IL-10)	0, 3, 7, 14, 28 days
Number of participants who developed anxiety and/or depression	0, 3, 7, 14, 28 days	Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)
Change of oxygenation indices (P/F ratio, lactates)	0, 3, 7, 14, 28 days

Trial Locations

Locations (1)

Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea; 🇮🇹 Roma, Italy