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| ID | Type | Description | Link |
|---|---|---|---|
| NORM_MPS_11 | Other Identifier | Epitech Group |
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| Name | Class |
|---|---|
| Azienda Ospedaliera "Sant'Andrea" | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA Group | Active Comparator | NormastĀ® MPS (mPEA and umPEA 300mg + 600mg) oral suspension: 2700mg/die in 3 doses for 28 days, in add-on to standard therapy |
|
| Control Group | Other | Standard therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension | Dietary Supplement | Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responder participants after 7 days of treatment | Responder: decrease ā„ 30% from baseline of IL-6 blood levels | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof.ssa Flaminia Coluzzi, MD | Azienda Ospedaliera Universitaria Sant'Andrea di Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anestesia e Rianimazione Azienda Ospedaliera Universitaria Sant'Andrea | Roma | 00189 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Standard Therapy | Combination Product | Standard therapy established for individual patients |
|
| 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 | leukocyte formula (lymphocytes, CD4 / CD8 ratio) | 0, 3, 7, 14, 28 days |
| Change of oxygenation indices (P/F ratio, lactates) | 0, 3, 7, 14, 28 days |
| 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 |
| 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 |
| Number of days of intensive care (ICU) hospitalization |
| 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |