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The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Huaier Granule
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Huaier granule

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged between 18 and 75 years, extremes included, male or female
  2. Patients diagnosed with mild or common type COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
  3. patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
  4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1
  5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Female subjects who are pregnant or breastfeeding.
  2. patients who are allergic to this medicine
  3. patients meet the contraindications of Huaier granule
  4. Patients with diabetes
  5. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
  6. patients can't take drugs orally

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)

    standard therapy

    Outcomes

    Primary Outcome Measures

    Mortality rate
    All cause mortality

    Secondary Outcome Measures

    Clinical status assessed according to the official guideline
    1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2>93% without oxygen inhalation ; severe type:Match any of the following：a. R≥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
    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,）.
    Duration (days) of supplemental oxygenation
    days
    Duration (days) of mechanical ventilation
    days
    The mean PaO2/FiO2
    Length of hospital stay (days)
    days
    Length of ICU stay (days)
    days
    Pulmonary function
    forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge

    Full Information

    First Posted
    February 27, 2020
    Last Updated
    March 14, 2020
    Sponsor
    Tongji Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04291053
    Brief Title
    The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19
    Official Title
    The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    August 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tongji Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    COVID-19, Huaier granule

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    550 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    standard therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Huaier Granule
    Intervention Description
    standard treatment + Huaier Granule 20g po tid for 2weeks
    Primary Outcome Measure Information:
    Title
    Mortality rate
    Description
    All cause mortality
    Time Frame
    up to 28 days
    Secondary Outcome Measure Information:
    Title
    Clinical status assessed according to the official guideline
    Description
    1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2>93% without oxygen inhalation ; severe type:Match any of the following：a. R≥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
    Time Frame
    up to 28 days
    Title
    The differences in oxygen intake methods
    Description
    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,）.
    Time Frame
    up to 28 days
    Title
    Duration (days) of supplemental oxygenation
    Description
    days
    Time Frame
    up to 28 days
    Title
    Duration (days) of mechanical ventilation
    Description
    days
    Time Frame
    up to 28 days
    Title
    The mean PaO2/FiO2
    Time Frame
    up to 28 days
    Title
    Length of hospital stay (days)
    Description
    days
    Time Frame
    up to 28 days
    Title
    Length of ICU stay (days)
    Description
    days
    Time Frame
    up to 28 days
    Title
    Pulmonary function
    Description
    forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge
    Time Frame
    up to 3 months after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 75 years, extremes included, male or female Patients diagnosed with mild or common type COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)" patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)" Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Female subjects who are pregnant or breastfeeding. patients who are allergic to this medicine patients meet the contraindications of Huaier granule Patients with diabetes 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lin Chen
    Phone
    +8613517260864
    Email
    chenlin_tj@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19

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