NCT04322344

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

March 23, 2020

Last Update Submit

September 11, 2020

Conditions

Coronavirus Infections

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • The differences in oxygen intake methods

    up to 30 days

  • Time of hospitalization (days)

    up to 30 days

  • Time of hospitalization in intensive care units

    up to 30 days

  • Pulmonary function

    up to 3 months after discharge

Study Arms (3)

oral escin group

EXPERIMENTAL

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

Drug: EscinDrug: standard therapy

control group

SHAM COMPARATOR

standard therapy

Drug: standard therapy

parenteral escin group

EXPERIMENTAL

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

Drug: EscinDrug: standard therapy

Interventions

EscinDRUG

treatment with escin or escinate sodium

oral escin groupparenteral escin group
standard therapyDRUG

antiviral drugs

control grouporal escin groupparenteral escin group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luca Gallelli

Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Interventions

EscinStandard of Care

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Pentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic ChemicalsSaponinsGlycosidesCarbohydratesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

LUCA GALLELLI

CONTACT

3339245656gallelli@unicz.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

March 23, 2020

Primary Completion

June 30, 2020

Study Completion

December 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

IT(1)