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
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 covid19
Started Oct 2020
Shorter than P25 for phase_4 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedAugust 25, 2021
August 1, 2021
4 months
September 24, 2020
August 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of responder participants after 7 days of treatment
Responder: decrease ≥ 30% from baseline of IL-6 blood levels
7 days
Secondary Outcomes (8)
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 coagulation indices (INR, fibrinogen, D-dimer)
0, 3, 7, 14, 28 days
Change of hematological parameters
0, 3, 7, 14, 28 days
- +3 more secondary outcomes
Other Outcomes (3)
Number of days of invasive mechanical ventilation (orotracheal intubation - IOT)
28 days
Number of days of non-invasive mechanical ventilation (Helmet, face mask)
28 days
Number of days of intensive care (ICU) hospitalization
28 days
Study Arms (2)
PEA Group
ACTIVE COMPARATORNormast® MPS (mPEA and umPEA 300mg + 600mg) oral suspension: 2700mg/die in 3 doses for 28 days, in add-on to standard therapy
Control Group
OTHERStandard therapy only
Interventions
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Standard therapy established for individual patients
Eligibility Criteria
You may qualify if:
- Intensive Care Unit Hospitalization for interstitial pneumonia due to COVID-19 diagnosis (nasal swab/sputum/bronchoalveolar lavage positive for Sars-Cov-2 infection)
You may not qualify if:
- Pregnancy or breastfeeding;
- Known allergy or hypersensitivity to the product or its excipients;
- Inability to take the product per os or via nasogastric tube.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epitech Group SpAlead
- Azienda Ospedaliera "Sant'Andrea"collaborator
Study Sites (1)
Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea
Roma, 00189, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof.ssa Flaminia Coluzzi, MD
Azienda Ospedaliera Universitaria Sant'Andrea di Roma
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2020
First Posted
September 29, 2020
Study Start
October 23, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08