Coronavirus Infections
Conditions
Brief summary
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.
Interventions
DRUGEscin
treatment with escin or escinate sodium
DRUGstandard therapy
antiviral drugs
Sponsors
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
University of Catanzaro
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | up to 30 days | All cause mortality |
| Clinical status evaluated in agreement with guidelines | up to 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The differences in oxygen intake methods | up to 30 days | 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 of hospitalization (days) | up to 30 days | days |
| Time of hospitalization in intensive care units | up to 30 days | days |
| Pulmonary function | up to 3 months after discharge | forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge |
Countries
Italy
Contacts
Primary ContactLUCA GALLELLI
Outcome results
None listed