Escin in Patients With Covid-19 Infection

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Drug: Escin
* Drug: standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 75 years, extremes included, male or female Positivity to covid-19 screening test in molecular biology In escin group: Low response to standard treatment Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Female subjects who are pregnant or breastfeeding. patients with previous history to allergy patients meet the contraindications of escin Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. patients can't take drugs orally

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral escin group<br>Standard therapy+Escin tablet 40mg*3, os for 12 days | Drug: Escin<br>* treatment with escin or escinate sodium<br>Drug: standard therapy<br>* antiviral drugs<br>|
| Sham Comparator: control group<br>standard therapy | Drug: standard therapy<br>* antiviral drugs<br>|
| Experimental: parenteral escin group<br>standard treatment + sodium Escinate 20mg iv/day for 12 days | Drug: Escin<br>* treatment with escin or escinate sodium<br>Drug: standard therapy<br>* antiviral drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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,） | 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 |