Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea
Roma, 00189, Italy
NCT Number: NCT04568876
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Roma, 00189, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Other names: Normast® MPS oral suspension
Standard therapy established for individual patients
Time frame: 7 days
Responder: decrease ≥ 30% from baseline of IL-6 blood levels
Time frame: 0, 3, 7, 14, 28 days
Time frame: 0, 3, 7, 14, 28 days
Time frame: 0, 3, 7, 14, 28 days
Time frame: 0, 3, 7, 14, 28 days
Time frame: 0, 3, 7, 14, 28 days
leukocyte formula (lymphocytes, CD4 / CD8 ratio)
Time frame: 0, 3, 7, 14, 28 days
Time frame: 0, 3, 7, 14, 28 days
Confusion Assessment Method-Intensive Care Unit (CAM-ICU) (0-1: no delirium; >1 delirium)
Time frame: 0, 3, 7, 14, 28 days
Hospital Anxiety and Depression Scale (HADS) (0: normal; 21: severe)
Time frame: 28 days
Time frame: 28 days
Time frame: 28 days
Epitech Group SpA
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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