Escin in Patients With Covid-19 Infection

Coronavirus Infections Clinical Trial

— add-on-COV2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322344
• Other study ID #: covid-19 add-on therapy
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 23, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: University of Catanzaro
• Contact: LUCA GALLELLI
• Phone: 3339245656
• Email: gallelli[@]unicz.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Escin
treatment with escin or escinate sodium
• standard therapy
antiviral drugs

Locations

Country	Name	City	State
Italy	Luca Gallelli	Catanzaro

Sponsors (3)

Lead Sponsor	Collaborator
University of Catanzaro	Azienda Ospedaliera Policlinico "Mater Domini", Azienda Ospedaliera Pugliese Ciaccio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	All cause mortality	up to 30 days
Primary	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	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
Secondary	Time of hospitalization (days)	days	up to 30 days
Secondary	Time of hospitalization in intensive care units	days	up to 30 days
Secondary	Pulmonary function	forced expiratory volume at one second ,maximum voluntary ventilation at 1month,2month,3month after discharge	up to 3 months after discharge