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

University of Catanzaro

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Coronavirus Infections

Treatments: Drug: Escin; Drug: standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04322344

covid-19 add-on therapy

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

oral escin group

Experimental group

Description:

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

Treatment:

Drug: Escin

Drug: standard therapy

control group

Sham Comparator group

Description:

standard therapy

Treatment:

Drug: standard therapy

parenteral escin group

Experimental group

Description:

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

Treatment:

Drug: Escin

Drug: standard therapy