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| Name | Class |
|---|---|
| Azienda Ospedaliera Pugliese Ciaccio | OTHER |
| Azienda Ospedaliera Universitaria Mater Domini, Catanzaro | OTHER |
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In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral escin group | Experimental | Standard therapy+Escin tablet 40mg*3, os for 12 days |
|
| control group | Sham Comparator | standard therapy |
|
| parenteral escin group | Experimental | standard treatment + sodium Escinate 20mg iv/day for 12 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escin | Drug | treatment with escin or escinate sodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | All cause mortality | up to 30 days |
| Clinical status evaluated in agreement with guidelines | mild type：no No symptoms, Radiological examination: no pneumonia; possible mild increase in C-reactive portein 2, moderate type: fever, cough, or other respiratory symptoms. Radiological examination: pneumonia, SpO2>93% without oxygen inhalation ; increase in C reactive protein, 3: severe type: a. Rate ≥30bpm；b. Pulse Oxygen Saturation (SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The differences in oxygen intake methods | Pulse Oxygen Saturation(SpO2)>93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LUCA GALLELLI | Contact | 3339245656 | 3339245656 | gallelli@unicz.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luca Gallelli | Recruiting | Catanzaro | 88100 | Italy |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D004928 | Escin |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
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| standard therapy | Drug | antiviral drugs |
|
| up to 30 days |
| Time of hospitalization (days) | days | up to 30 days |
| Time of hospitalization in intensive care units | days | up to 30 days |
| Pulmonary function | forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge | up to 3 months after discharge |
| D007239 |
| Infections |
| D009930 |
| Organic Chemicals |
| D012503 | Saponins |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |