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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infections
• Intervention / Treatment: Drug: Escin; Drug: standard therapy

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Luca Gallelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	All cause mortality	up to 30 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge	up to 3 months after discharge
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
Time of hospitalization (days)	days	up to 30 days
Time of hospitalization in intensive care units	days	up to 30 days

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Collaborators: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro; Azienda Ospedaliera Pugliese Ciaccio

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Coronavirus Infections; Infections
• Other Study ID Numbers: covid-19 add-on therapy

Drug and device information, study documents

• 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