A Phase 2/3 interventional study of Escin and standard therapy in Coronavirus Infections, sponsored by University of Catanzaro. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by University of Catanzaro · Phase 2/3, Interventional, and Supportive care
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →University of Catanzaro is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard therapy+Escin tablet 40mg\*3, os for 12 days
Drug: Escin · Drug: standard therapy
standard therapy
Drug: standard therapy
standard treatment + sodium Escinate 20mg iv/day for 12 days
Drug: Escin · Drug: standard therapy
treatment with escin or escinate sodium
antiviral drugs
Mortality rate
All cause mortality
Time frame: 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
Time frame: up to 30 days
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,）
Time frame: up to 30 days
Time of hospitalization (days)
days
Time frame: up to 30 days
Time of hospitalization in intensive care units
days
Time frame: up to 30 days
Pulmonary function
forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge
Time frame: up to 3 months after discharge
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Catanzaro