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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322344
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Policlinico "Mater Domini"
Information provided by (Responsible Party):
Luca Gallelli, University of Catanzaro

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infections Drug: Escin Drug: standard therapy Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Escin

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




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: up to 30 days ]
    All cause mortality

  2. Clinical status evaluated in agreement with guidelines [ Time Frame: up to 30 days ]
    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 :
  1. The differences in oxygen intake methods [ Time Frame: up to 30 days ]
    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,)

  2. Time of hospitalization (days) [ Time Frame: up to 30 days ]
    days

  3. Time of hospitalization in intensive care units [ Time Frame: up to 30 days ]
    days

  4. Pulmonary function [ Time Frame: up to 3 months after discharge ]
    forced expiratory volume at one second ,maximum voluntary ventilation at 1month,2month,3month after discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322344


Contacts
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Contact: LUCA GALLELLI 3339245656 ext 3339245656 gallelli@unicz.it

Locations
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Italy
Luca Gallelli Recruiting
Catanzaro, Italy, 88100
Contact: LUCA GALLELLI    3339245656 ext 3339245656    gallelli@unicz.it   
Sponsors and Collaborators
University of Catanzaro
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Policlinico "Mater Domini"
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Responsible Party: Luca Gallelli, Clinical Professor, University of Catanzaro
ClinicalTrials.gov Identifier: NCT04322344    
Other Study ID Numbers: covid-19 add-on therapy
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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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
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases