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Micronized and Ultramicronized Palmitoylethanolamide in COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04568876
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera "Sant'Andrea"
Information provided by (Responsible Party):
Epitech Group SpA

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension Combination Product: Standard Therapy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PEA Group
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
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Other Name: Normast® MPS oral suspension

Combination Product: Standard Therapy
Standard therapy established for individual patients
Control Group
Standard therapy only
 Combination Product: Standard Therapy
Standard therapy established for individual patients


Outcome Measures
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Primary Outcome Measures :
  1. Number of responder participants after 7 days of treatment [ Time Frame: 7 days ]
    Responder: decrease ≥ 30% from baseline of IL-6 blood levels


Secondary Outcome Measures :
  1. 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 ]
  2. Change of anti-inflammatory markers (IL-4, IL-10) [ Time Frame: 0, 3, 7, 14, 28 days ]
  3. Change of brain damage markers (S100b, ENS) [ Time Frame: 0, 3, 7, 14, 28 days ]
  4. Change of coagulation indices (INR, fibrinogen, D-dimer) [ Time Frame: 0, 3, 7, 14, 28 days ]
  5. Change of hematological parameters [ Time Frame: 0, 3, 7, 14, 28 days ]
    leukocyte formula (lymphocytes, CD4 / CD8 ratio)

  6. Change of oxygenation indices (P/F ratio, lactates) [ Time Frame: 0, 3, 7, 14, 28 days ]
  7. Number of participants who developed delirium [ Time Frame: 0, 3, 7, 14, 28 days ]
    Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; >1 delirium)

  8. Number of participants who developed anxiety and/or depression [ Time Frame: 0, 3, 7, 14, 28 days ]
    Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)


Other Outcome Measures:
  1. Number of days of invasive mechanical ventilation (orotracheal intubation - IOT) [ Time Frame: 28 days ]
  2. Number of days of non-invasive mechanical ventilation (Helmet, face mask) [ Time Frame: 28 days ]
  3. Number of days of intensive care (ICU) hospitalization [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568876


Contacts
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Contact: Epitech Group SpA Clinical Research +39 049 8016784 info@epitech.it

Locations
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Italy
Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea Recruiting
Roma, Italy, 00189
Contact: Prof.ssa Flaminia Coluzzi, MD         
Principal Investigator: Prof.ssa Flaminia Coluzzi, MD         
Sponsors and Collaborators
Epitech Group SpA
Azienda Ospedaliera "Sant'Andrea"
Investigators
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Principal Investigator: Prof.ssa Flaminia Coluzzi, MD Azienda Ospedaliera Universitaria Sant'Andrea di Roma
More Information
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Responsible Party: Epitech Group SpA
ClinicalTrials.gov Identifier: NCT04568876    
Other Study ID Numbers: NORM_MPS-COVID
NORM_MPS_11 ( Other Identifier: Epitech Group )
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
 Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists