add-on-COV2: Escin in Patients With Covid-19 Infection

Sponsor

University of Catanzaro (Other)

Overall Status

Recruiting

CT.gov ID

NCT04322344

Collaborator

Azienda Ospedaliera Pugliese Ciaccio (Other), Azienda Ospedaliera Universitaria Mater Domini, Catanzaro (Other)

120

Enrollment

Location

Arms

9.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections	Drug: Escin Drug: standard therapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 23, 2020

Actual Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: oral escin group

Standard therapy+Escin tablet 40mg*3, os for 12 days

Drug: Escin

treatment with escin or escinate sodium

Drug: standard therapy

antiviral drugs

Sham Comparator: control group

standard therapy

Drug: standard therapy

antiviral drugs

Experimental: parenteral escin group

standard treatment + sodium Escinate 20mg iv/day for 12 days

Drug: Escin

treatment with escin or escinate sodium

Drug: standard therapy

antiviral drugs

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luca Gallelli	Catanzaro		Italy	88100

Sponsors and Collaborators

University of Catanzaro
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luca Gallelli, Clinical Professor, University of Catanzaro

ClinicalTrials.gov Identifier:

NCT04322344

Other Study ID Numbers:

covid-19 add-on therapy

First Posted:

Mar 26, 2020

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infections

Coronavirus Infections

Study Results

No Results Posted as of Sep 16, 2020