Escin in Patients With Covid-19 Infection

Phase 2

• Conditions: Coronavirus Infections
• Interventions: Drug: standard therapy; Drug: Escin

• Registration Number: NCT04322344
• Lead Sponsor: University of Catanzaro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-23
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-26
• Primary Completion: 2020-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	standard therapy	standard therapy
parenteral escin group	Escin	standard treatment + sodium Escinate 20mg iv/day for 12 days
oral escin group	standard therapy	Standard therapy+Escin tablet 40mg\*3, os for 12 days
parenteral escin group	standard therapy	standard treatment + sodium Escinate 20mg iv/day for 12 days
oral escin group	Escin	Standard therapy+Escin tablet 40mg\*3, os for 12 days

Primary Outcome Measures

Name	Time	Method
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
Mortality rate	up to 30 days	All cause mortality

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Luca Gallelli; 🇮🇹 Catanzaro, Italy