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Escin in Patients With Covid-19 Infection (add-on-COV2)

Primary Purpose

Coronavirus Infections

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Escin
standard therapy
Sponsored by
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronavirus Infections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Luca GallelliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

oral escin group

control group

parenteral escin group

Arm Description

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

standard therapy

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

Outcomes

Primary Outcome Measures

Mortality rate
All cause mortality
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

Secondary Outcome Measures

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,）
Time of hospitalization (days)
days
Time of hospitalization in intensive care units
days
Pulmonary function
forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge

Full Information

First Posted
March 23, 2020
Last Updated
September 11, 2020
Sponsor
University of Catanzaro
Collaborators
Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
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1. Study Identification

Unique Protocol Identification Number
NCT04322344
Brief Title
Escin in Patients With Covid-19 Infection
Acronym
add-on-COV2
Official Title
Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro
Collaborators
Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral escin group
Arm Type
Experimental
Arm Description
Standard therapy+Escin tablet 40mg*3, os for 12 days
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
standard therapy
Arm Title
parenteral escin group
Arm Type
Experimental
Arm Description
standard treatment + sodium Escinate 20mg iv/day for 12 days
Intervention Type
Drug
Intervention Name(s)
Escin
Intervention Description
treatment with escin or escinate sodium
Intervention Type
Drug
Intervention Name(s)
standard therapy
Intervention Description
antiviral drugs
Primary Outcome Measure Information:
Title
Mortality rate
Description
All cause mortality
Time Frame
up to 30 days
Title
Clinical status evaluated in agreement with guidelines
Description
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
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
The differences in oxygen intake methods
Description
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 Frame
up to 30 days
Title
Time of hospitalization (days)
Description
days
Time Frame
up to 30 days
Title
Time of hospitalization in intensive care units
Description
days
Time Frame
up to 30 days
Title
Pulmonary function
Description
forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge
Time Frame
up to 3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LUCA GALLELLI
Phone
3339245656
Ext
3339245656
Email
gallelli@unicz.it
Facility Information:
Facility Name
Luca Gallelli
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUCA GALLELLI
Phone
3339245656
Ext
3339245656
Email
gallelli@unicz.it

12. IPD Sharing Statement

Learn more about this trial

Escin in Patients With Covid-19 Infection

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