Escin in Patients With Covid-19 Infection

NCT ID: NCT04322344

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Coronavirus Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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oral escin group

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

Group Type EXPERIMENTAL

Escin

Intervention Type DRUG

treatment with escin or escinate sodium

standard therapy

Intervention Type DRUG

antiviral drugs

control group

standard therapy

Group Type SHAM_COMPARATOR

standard therapy

Intervention Type DRUG

antiviral drugs

parenteral escin group

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

Group Type EXPERIMENTAL

Escin

Intervention Type DRUG

treatment with escin or escinate sodium

standard therapy

Intervention Type DRUG

antiviral drugs

Interventions

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Escin

treatment with escin or escinate sodium

Intervention Type DRUG

standard therapy

antiviral drugs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Pugliese Ciaccio

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

OTHER

Sponsor Role collaborator

University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luca Gallelli

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luca Gallelli

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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LUCA GALLELLI

Role: CONTACT

3339245656 ext. 3339245656

Facility Contacts

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LUCA GALLELLI

Role: primary

3339245656 ext. 3339245656

Other Identifiers

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covid-19 add-on therapy

Identifier Type: -

Identifier Source: org_study_id

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